Medicines in Development for Mental Illnesses

America’s biopharmaceutical research com-panies are developing 187 medicines to help the nearly 60 million American adults now suf-fering from some form of mental illness—from anxiety to depression and from schizophrenia to addictive disorders, such as dependence on alcohol or drugs. All of the medicines are either in clinical trials or awaiting review by the Food and Drug Administration. Over the past half century, biopharmaceutical research has helped transform mental illnesses from misunderstood causes of shame and fear into often highly treatable conditions. For example, medicines for treating depression are helping thousands of people live productive lives and breakthrough schizophrenia medicines have enabled patients to be treated in the commu-nity rather than being institutionalized.Despite such progress, mental illnesses con-tinue to exact a heavy human and economic toll. The National Institute of Mental Health (NIMH) estimates that 1 in 4 American adults suffer from a diagnosable mental disorder. Ac-cording to the NIMH, serious mental illnesses cost the United States more than $317 billion

annually in lost wages, health care expendi-tures, and disability benefits.Examples of some medicines now being tested to treat mental illnesses include: • A medicine to potentially treat the various

symptoms associated with schizophrenia, with diminished side effects.

• An intranasal medicine for the treatment of anxiety which has shown to improve symptoms within several minutes of administration.

Researching and developing new medicines remains a risky investment and lengthy process. But advances in our understanding of mental illnesses and how to treat them have allowed America’s biopharmaceutical com-panies to conduct the cutting-edge research needed to reduce the destructive toll of these disorders and to allow more patients to lead healthier, happier, more productive lives.

Pharmaceutical Research Companies Are Developing Nearly 200 Medicines to Treat Mental Illnesses and Addictive Disorders

Medicines in Development

Mental Illnessespresented by america’s biopharmaceutical research companies

2012 RepoRt

26 26

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36

Schi

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Anxi

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Dis

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Medicines in Development

For Selected Mental Illnesses

And Addictive Disorders 1 in 4 American adults suffer from a diagnosable mental illness

ADDICTIVE DISORDERS

EATING DISORDERSDEVELOPMENTAL DISORDERS

DEPRESSION

ATTENTION-DEFICIT/HYPERACTIVITY DISORDERER

SSLEEEP DISORDERSSCHIZOPHRENIA

ANXIETY DISORDERS

PERSONALITY DISORDERS

Medicines in Development Mental Illnesses 20122

*For more information about a specific medicine in this report, please call the telephone number listed.

Sleep Disorders

Schizophrenia

Eating Disorders

Developmental Disorders

Depression

Cognition Disorders

Attention-Deficit/Hyperactivity Disorder

Anxiety Disorders

Addictive Disorders 26

26

52

20

10

10

3

36

22

Other 9

* Some medicines are in development for more than one disorder.

Medicines in Development for Mental Illnesses*

Medicines in Development for Mental Illnesses

addIctIve dIsorders

product Name Sponsor Indication Development Status*

ALKS33(samidorphan)

AlkermesCambridge, MA

drug dependence Phase I(617) 494-0171

ALKS5461(buprenorphine/samidorphan)


cocaine dependence(see also depression)

Phase I(617) 494-0171

ARD-1600(nicotine inhalation)

AradigmHayward, CA

smoking dependence Phase I(510) 265-9000

buprenorphine/naloxonefixed-dose combination

OrexoUppsala, Sweden

opioid dependence Phase III www.orexo.com

buprenorphine/naloxonetransmucosal

BioDelivery Sciences International Raleigh, NC

opioid dependence Phase I(919) 582-9050

Ch-mAb7F9 InterveXionLittle Rock, AR

drug dependence Phase I (501) 554-2377

Medicines in Development Mental Illnesses 2012 3


addIctIve dIsorders

product Name Sponsor Indication Development Status

CPP-109(vigabatrin)

Catalyst PharmaceuticalCoral Gables, FL

alcohol dependence, cocaine dependence(Fast Track)

Phase II(305) 529-2522

ecopipam(PSYRX101)

Psyadon PharmaceuticalsGermantown, MD

pathological gambling(see also other)

Phase II(301) 919-2020

EMB-001 Embera NeuroTherapeuticsShreveport, LA

cocaine dependence Phase I completed(318) 213-0198

GSK561679(verucerfont)

GlaxoSmithKlineRsch. Triangle Park, NC

stress-related alcohol abuse(see also anxiety)

Phase II(888) 825-5249

ibudilast(MN-166/AV11)

MediciNovaSan Diego, CA

methamphetamine dependence Phase I (858) 373-1500

INT-0003/2005 Cary PharmaceuticalsGreat Falls, VAIntelGenx Quebec, Canada

nicotine dependence Phase I(703) 759-7460(514) 331-7440

KRL-901 Krele Pharmaceuticals(TONIX Pharmaceuticals)New York, NY

alcohol dependence in clinical trials(212) 908-9155

lofexidine US WorldMedsLouisville, KY

opioid dependence Phase III(502) 753-2094

MT-7716 Mitsubishi Tanabe PharmaDevelopment AmericaWarren, NJ

alcohol dependence Phase I(908) 607-1950

NanoBUp™buprenorphine/naloxone

NanotherapeuticsAlachua, FL

opioid dependence Phase I completed(386) 462-9663

neboglamine(CR-224)

Rottapharm | MadausMonza, Italy

cocaine dependence Phase IIwww.rotta.com

nepicastat oral (SYN117)

Biotie TherapiesSouth San Francisco, CA

cocaine dependence(see also anxiety)

Phase II completed(650) 244-4850

NIC002 Novartis PharmaceuticalsEast Hanover, NJ

nicotine dependence Phase II(888) 669-6682

NicVAX™nicotine abuse vaccine

GlaxoSmithKlineRsch. Triangle Park, NCNabi BiopharmaceuticalsRockville, MD

nicotine dependence (Fast Track) Phase III(888) 825-5249(800) 685-5579



addIctIve dIsorders


OMS-403 OmerosSeattle, WANew York State Psychiatric InstituteNew York, NY

nicotine dependence, opioid dependence

Phase II(206) 676-5000

probuphine®

bupenorphine implantTitan PharmaceuticalsSouth San Francisco, CA

opioid dependence Phase III(650) 244-4990

Sabril®vigabatrin

LundbeckDeerfield, IL

cocaine dependence (Fast Track)

--------------------------------------------------methamphetamine addiction

Phase II (866) 337-6996-------------------------------------------Phase I (866) 337-6996

SEL-068 Selecta BiosciencesWatertown, MA

smoking dependence Phase I (617) 923-1400

TA-CD(cocaine abuse vaccine)

Celtic PharmaHamilton, Bermuda

cocaine dependence Phase IIwww.celticpharma.com

X-22 22nd Century GroupWestport, CT

smoking dependence Phase II(203) 222-7399

anxIety dIsorders


ABT-436(vasopressin-1b receptor antagonist)

Abbott LaboratoriesAbbott Park, IL

anxiety(see also depression)

Phase I(847) 937-6100

alprazolam sublingual PfizerNew York, NY

anxiety Phase I completed(860) 732-5156

alprazolam transdermal Nuvo ResearchMississauga, Canada

panic disorder Phase I(905) 673-6980

AVN 101(serotonin 6 receptor antagonist)

Avineuro PharmaceuticalsSan Diego, CA

anxiety Phase II(858) 436-1537

AVN 397 Avineuro PharmaceuticalsSan Diego, CA

anxiety Phase II(858) 436-1537

BNC210 Bionomics Adelaide, AustraliaIronwood Pharmaceuticals Cambridge, MA

anxiety Phase I completed(617) 621-7722



anxIety dIsorders


carvedilol Columbia Northwest PharmaceuticalsBellevue, WA

post-traumatic stress disorder Phase II(877) 453-0404

CX157 CeNeRx PharmaCary, NC


Phase I(919) 234-4072

CXB722(pivagabine prodrug)

CeNeRx BioPharmaCary, NC


Phase II(919) 234-4072

Cymbalta®

duloxetineEli LillyIndianapolis, IN

generalized anxiety disorder (pediatric)(see also depression)

Phase III(800) 545-5979

ganaxolone Marinus PharmaceuticalsBranford, CT

post-traumatic stress disorder Phase II(203) 315-0566

GSK561679(verucerfont)


post-traumatic stress disorder(see also addictive)

Phase II(888) 825-5249

INtUNIV™guanfacine extended-release

Shire PharmaceuticalsWayne, PA

anxiety disorders (pediatric), generalized anxiety disorder (pediatric), social phobia (pediatric)

Phase IIwww.shire.com


generalized anxiety disorder in clinical trials(212) 908-9155

nepicastat oral (SYN117)

Biotie TherapiesSouth San Francisco, CA

post-traumatic stress disorder(see also addictive)

Phase II(650) 244-4850

PH94B Pherin PharmaceuticalsLos Altos, CA

generalized social phobia Phase II(650) 961-2703

PRX-3140 NanotherapeuticsAlachua, FL

post-traumatic stress disorder Phase II (386) 462-9663

SPN-805 Supernus PharmaceuticalsRockville, MD

anxiety Phase I(301) 838-2500


anxiety Phase I(301) 838-2500

SRX246 Azevan PharmaceuticalsBethlehem, PA

traumatic stress disorder Phase I(610) 419-1057



anxIety dIsorders


tedatioxetine LundbeckDeerfield, ILTakeda Pharmaceuticals U.S.A.Deerfield, IL

generalized anxiety disorder(see also depression)

Phase I(866) 337-6996(877) 825-3327

TGFK08AA Fabre-Kramer PharmaceuticalsHouston, TX

generalized anxiety disorder Phase II(713) 975-6900

TGWOOAA Fabre-Kramer PharmaceuticalsHouston, TX

generalized anxiety disorder,social phobia

Phase II(713) 975-6900

TO-2061(ondansetron/risperidone)

Transcept PharmaceuticalsPt. Richmond, CA

obsessive-compulsive disorder Phase II(510) 215-3500

vortioxetine LundbeckDeerfield, ILTakeda Pharmaceuticals U.S.A.Deerfield, IL

generalized anxiety disorder(see also depression)

--------------------------------------------------anxiety disorders (pediatric)

Phase III(866) 337-6996(877) 825-3327-------------------------------------------Phase II(866) 337-6996(877) 825-3327

YKP-3089 SK Life ScienceFair Lawn, NJ


Phase Iwww.sklsi.com

attentIon-defIcIt/HyperactIvIty dIsorder


amfetamine transdermal Noven PharmaceuticalsMiami, FL

attention-deficit/hyperactivity disorder (ADHD)

Phase I(305) 253-5099

AZD5213(histamine-3 receptor antagonist)

AstraZenecaWilmington, DE

ADHD Phase I (800) 236-9933

bavisant(JNJ-31001074)

Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

ADHD

--------------------------------------------------ADHD (pediatric)

Phase II(800) 817-5286-------------------------------------------Phase II(800) 817-5286

COL-171 Collegium PharmaceuticalsCumberland, RI

ADHD in clinical trials(401) 762-2000





CX1739 Cortex PharmaceuticalsIrvine, CA

ADHD Phase I completed(949) 727-3157

EB-1020(triple reuptake inhibitor)

Euthymics BioscienceCambridge, MA

ADHD Phase I(617) 758-0300

edivoxetine(LY2216684)

Eli LillyIndianapolis, IN

ADHD (pediatric)(see also depression)

Phase II(800) 545-5979

KP106 KemPharmNorth Liberty, IA

ADHD Phase I(319) 665-2575


ADHD in clinical trials(212) 908-9155

methylphenidate extended-release

Purdue PharmaStamford, CT

ADHD Phase III(203) 588-8000

NWP06(methylphenidate extended-release suspension)

NextWave PharmaceuticalsCupertino, CA

ADHD application submitted(408) 342-1300

NWP09(methylphenidate extended-release chewable tablets)

NextWave PharmaceuticalsCupertino, CA

ADHD Phase II(408) 342-1300

OPC-34712(brexpiprazole)

LundbeckDeerfield, ILOtsuka America PharmaceuticalRockville, MD

ADHD(see also depression, schizophrenia)

Phase II(866) 337-6996(800) 562-3974

ORADUR-ADHD(sustained-release oral therapy)

DURECT Cupertino, CA

ADHD Phase I(408) 777-1417

sofinicline Abbott LaboratoriesAbbott Park, ILNeuroSearchBallerup, Denmark


SPN-810(molindone)

Supernus PharmaceuticalsRockville, MD

conduct disorder and impulsive aggression in ADHD (pediatric)

Phase II(301) 838-2500


ADHD Phase I(301) 838-2500


ADHD (adults) Phase I/II(301) 838-2500





TC-5619 TargaceptWinston-Salem, NC

ADHD(see also cognition)

Phase II(336) 480-2100

TD-9855 TheravanceSouth San Francisco, CA


cognItIon dIsorders


AMG 747(GlyT-1 inhibitor)

AmgenThousand Oaks, CA

cognitive deficits and negative symptoms associated with schizophrenia

Phase II(800) 772-6436

AQW051 Novartis PharmaceuticalsEast Hanover, NJ

cognition disorders associated with schizophrenia

Phase II(888) 669-6682

AV965(serotonin-1A antagonist)

Avera PharmaceuticalsSan Diego, CA

cognition impairment associated with schizophrenia

Phase I(858) 847-0650

davunetide intranasal Allon TherapeuticsVancouver, Canada

mild cognitive impairment associated with schizophrenia


irdabisant(CEP-26401)

CephalonFrazer, PA


Phase I(610) 344-0200

LU AE58054 LundbeckDeerfield, IL

cognitive impairment associatedwith schizophrenia

Phase II(800) 455-1141

RG1662(GABA receptor)

RocheNutley, NJ

cognitive disorders in patients withDown’s syndrome

Phase I(973) 235-5000

sabcomeline(BCI-224)

BrainCellsSan Diego, CA

cognitive decline associated with schizophrenia

Phase I(858) 812-7700

SYN-120 Biotie TherapiesSouth San Francisco, CA


Phase I(650) 244-4850

TC-5619 TargaceptWinston-Salem, NC

cognition disorders associated with schizophrenia(see also ADHD)

Phase II(336) 480-2100



depressIon


ABT-436(vasopressin-1b receptor antagonist)


major depressive disorder(see also anxiety)

Phase I(847) 937-6100

ADX N05 Aerial BioPharmaMorrisville, NC

depressive disorders (adjunctive treatment)(see also sleep)

Phase I(919) 460-9500

amitifadine(EB-1010)

Euthymics BioscienceCambridge, MA

major depressive disorder Phase II/III(617) 758-0300

ARA 290 Araim PharmaceuticalsOssining, NY

depression Phase II(914) 762-7586

ALKS5461(buprenorphine/samidorphan)


major depressive disorder(see also addictive)

Phase II(617) 494-0171

aripiprazole/escitalopramfixed-dose combination

Otsuka America PharmaceuticalRockville, MD

major depressive disorder Phase III(800) 562-3974

armodafinil CephalonFrazer, PA

bipolar depression(see also eating)

Phase III(610) 344-0200

AZD6765(NMDA receptor antagonist)


major depressive disorder Phase II(800) 236-9933

BCI-632(mGluR2/3 antagonist)


major depressive disorder Phase I(858) 812-7700

BCI-838(mGluR2/3 antagonist)



BCI-952(buspirone/melatonin)



bipolar disorder NCE Eli LillyIndianapolis, IN

bipolar disorder Phase I(800) 545-5979

BMS-820836(triple reuptake inhibitor)

Bristol-Myers SquibbPrinceton, NJ


cariprazine Forest LaboratoriesNew York, NYGedeon RichterBudapest, Hungary

bipolar disorder(see also schizophrenia)--------------------------------------------------bipolar depression, major depressive disorder

Phase III(800) 947-5227-------------------------------------------Phase II(800) 947-5227



depressIon


CX157 CeNeRx PharmaCary, NC

treatment-resistant depression(see also anxiety)

Phase I(919) 234-4072

CXB722(pivagabine prodrug)

CeNeRx BioPharmaCary, NC

depressive disorders(see also anxiety)

Phase II(919) 234-4072

Cymbalta®

duloxetineEli LillyIndianapolis, IN

major depressive disorder (pediatric)(see also anxiety)

Phase III(800) 545-5979

depression NCE Eli LillyIndianapolis, IN

depression Phase I(800) 545-5979

depression NCE Eli LillyIndianapolis, IN

depression Phase I(800) 545-5979

DSP-1053 Sunovion PharmaceuticalsMarlborough, MA


edivoxetine(LY2216684)


major depressive disorder (see also ADHD)

Phase III(800) 545-5979

elpetrigine Jazz PharmaceuticalsDublin, Ireland

bipolar disorder Phase Iwww.jazzpharma.com

GLYX-13 NaurexEvanston, IL


HT-2157 Dart NeuroScienceSan Diego, CA

major depressive disorder Phase I/II(858) 736-3060

Korlym™mifepristone

Corcept TherapeuticsMenlo Park, CA

psychotic major depression(Fast Track)

Phase III(650) 327-3270

Lamictal®lamotrigine


bipolar disorder (elderly)

--------------------------------------------------bipolar disorder (pediatric)

Phase III completed(888) 825-5249-------------------------------------------Phase III(888) 825-5249

Latuda®

lurasidoneSunovion PharmaceuticalsMarlborough, MA

bipolar disorder, major depressive disorder

Phase III(508) 481-6700

levomilnacipran Forest LaboratoriesNew York, NY

major depressive disorder Phase III(800) 947-5227



depressIon


lithium Columbia Northwest PharmaceuticalsBellevue, WA

suicide ideation in patients with depressive mood disorders

Phase II(877) 453-0404

Motiva™nefiracetam

Neuren PharmaceuticalsAuckland, New Zealand

major depressive disorder post stroke

Phase IIwww.neurenpharma.com

nemifitide Tetragenex PharmaceuticalsPark Ridge, NJ

major depressive disorder Phase II completed(201) 505-1300

NSI-189 NeuralstemRockville, MD




major depressive disorder(see also ADHD, schizophrenia)

Phase III(866) 337-6996(800) 562-3974

PNB01(citalopram/pipamperone)

PharmaNeuroBoostAlken, Belgium

major depressive disorder Phase IIIwww.pharmaneuroboost.com

pristiq®

desvenlafaxinePfizerNew York, NY

major depressive disorder (pediatric)

Phase III(860) 732-5156

RG1578(mGluR2 modulator)

RocheNutley, NJ


RG7090(mGluR5 antagonist)

RocheNutley, NJ

major depressive disorder(see also developmental)

Phase II(973) 235-5000

RO4995819 RocheNutley, NJ


Rozerem®

ramelteonTakeda Pharmaceuticals U.S.A.Deerfield, IL

bipolar depression, bipolar disorder(see also sleep)

Phase II(877) 825-3327

sabcomeline(BCI-224)



Saphris®

asenapineMerckWhitehouse Station, NJ

bipolar disorder (pediatric)(see also schizophrenia)

Phase III(800) 672-6372

SEP-228432 Sunovion PharmaceuticalsMarlborough, MA

depressive disorders Phase I(508) 481-6700



depressIon


Seroquel XR®

quetiapine fumarateextended-release


bipolar depression (pediatric) Phase III completed(800) 236-9933

SKL-10406 SK Life ScienceFair Lawn, NJ

major depressive disorder Phase Iwww.sklsi.com


bipolar disorder Phase I(301) 838-2500

tasimelteon Vanda PharmaceuticalsWashington, DC

major depressive disorder(see also sleep)

Phase I/II(202) 734-3400

tedatioxetine LundbeckDeerfield, ILTakeda Pharmaceuticals U.S.A.Deerfield, IL


Phase I(866) 337-6996(877) 825-3327

TGBA01AD Fabre-Kramer PharmaceuticalsHouston, TX


venlafaxine deuterium-substituted

Auspex PharmaceuticalsLa Jolla, CA


vortioxetine LundbeckDeerfield, ILTakeda Pharmaceuticals U.S.A.Deerfield, IL


--------------------------------------------------depressive disorders (pediatric)

Phase III(866) 337-6996(877) 825-3327-------------------------------------------Phase II(866) 337-6996(877) 825-3327

Vyvanse®

lisdexamfetamineShire PharmaceuticalsWayne, PA

bipolar depression, major depressive disorder(see also eating, schizophrenia, sleep)

Phase IIIwww.shire.com

YKP-3089 SK Life ScienceFair Lawn, NJ

bipolar disorder(see also anxiety)

Phase Iwww.sklsi.com



developMental dIsorders


AFQ056 Novartis PharmaceuticalsEast Hanover, NJ

fragile X syndrome Phase II/III(888) 669-6682

AT001(fluoxetine-rapid dissolve)(orphan Drug)

Autism TherapeuticsLondon, United Kingdom

autism (Fast Track) Phase IIIwww.autismtherapeutics.com

AT002(fenobam) (orphan Drug)

Autism TherapeuticsLondon, United Kingdom

fragile X syndrome Phase I/II www.autismtherapeutics.com

CM-AT CureMarkRye, NY

autism (Fast Track) Phase III(914) 925-3450

CYP2001(carbetocin intranasal)

Cypress Bioscience(Royalty Pharma)New York, NY

autism (Fast Track) Phase I(212) 883-0200

Namenda®

memantineForest LaboratoriesNew York, NY

Asperger syndrome (pediatric), autism (pediatric)

Phase II(800) 947-5227

RG7090(mGluR5 antagonist)

RocheNutley, NJ

fragile X syndrome(see also depression)

Phase II(973) 235-5000

RG7314(vasopressin-1 receptor antagonist)

RocheNutley, NJ

autism Phase I(973) 235-5000

STX107(mGluR5 antagonist)

Seaside TherapeuticsCambridge, MA

fragile X syndrome Phase II(617) 374-9009

STX209(GABA-B receptor agonist)(orphan Drug)

Seaside TherapeuticsCambridge, MA

fragile X syndrome, fragile X syndrome (pediatric)--------------------------------------------------autism (pediatric)




eatIng dIsorders


anamorelin Helsinn TherapeuticsBridgewater, NJ

anorexia (Fast Track) Phase III(908) 231-1435

armodafinil CephalonFrazer, PA

binge-eating disorder(see also depression)

Phase III(610) 344-0200

Vyvanse®


binge-eating disorder(see also depression, schizophrenia, sleep)


scHIzopHrenIa


Abilify® IM Depotaripiprazole(once-monthly)


schizophrenia application submitted(866) 337-6996(800) 562-3974

ABT-126(alpha-7 neuronal nicotinicreceptor antagonist)


schizophrenia Phase II(847) 937-6100

ABT-288(neurotransmitter receptor modulator)



ALKS9070/ALKS9072(aripiprazole injectable)


schizophrenia Phase III(617) 494-0171

AM-831 ACADIA PharmaceuticalsSan Diego, CA

schizophrenia Phase I(858) 558-2871

AMG 579(PDE10A inhibitor)

AmgenThousand Oaks, CA

schizoaffective disorder, schizophrenia

Phase I(800) 772-6436

ATON-005 ATON PharmaLawrenceville, NJ

psychotic disorders Phase I(609) 671-9010

AVN 211(serotonin 6 receptor antagonist)

Avineuro PharmaceuticalsSan Diego, CA

schizophrenia Phase II completed(858) 436-1537



scHIzopHrenIa


bitopertin(RG1678)

RocheNutley, NJ

schizophrenia Phase III(973) 235-5000

BL-1020 BioLineRxJerusalem, Israel

schizophrenia Phase IIwww.biolinerx.com

cariprazine Forest LaboratoriesNew York, NYGedeon RichterBudapest, Hungary

schizophrenia (see also depression)

Phase III(800) 947-5227

CM-2395 Cenomed BioSciencesIrvine, CA

schizophrenia in clinical trials(949) 838-0344

DCCCyB MerckWhitehouse Station, NJ


EVP-6124(α7-nAChR agonist)

EnVivo PharmaceuticalsWatertown, MA


Fanapt®iloperidoneinjectable

Novartis PharmaceuticalsEast Hanover, NJ

schizophrenia Phase I/II(888) 669-6682

GSK239512 GlaxoSmithKlineRsch. Triangle Park, NC


Invega®

paliperidoneJohnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

schizoaffective disorder(prevention of relapse)

Phase III(800) 817-5286

ITI-007(high-dose formulation)

Intra-Cellular TherapiesNew York, NY

schizophrenia(see also sleep)

Phase II(212) 923-3344

JNJ-17305600 Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ


JNJ-37822681 Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ


MK-2637 MerckWhitehouse Station, NJ

schizophrenia Phase I completed(800) 672-6372





scHIzopHrenIa


olanzapineoral disintegrating tablet

INVENT PharmaceuticalsDel Mar, CA

psychotic disorders Phase I completed(858) 945-8576



schizophrenia (see also ADHD, depression)

Phase III(866) 337-6996(800) 562-3974

PF-02545920 PfizerNew York, NY






pitolisant BioprojetParis, FranceFerrerBarcelona, Spain

schizophrenia Phase IIwww.bioprojet.frwww.ferrergrupo.com

pomaglumetad(LY2140023)


schizophrenia (monotherapy)

--------------------------------------------------schizophrenia (add-on therapy)


RP5063 Reviva PharmaceuticalsSan Jose, CA

schizoaffective disorder, schizophrenia

Phase II(408) 960-2209

Saphris®

asenapineMerckWhitehouse Station, NJ

schizophrenia (pediatric)(see also depression)

Phase I(800) 672-6372

SB773812 GlaxoSmithKlineRsch. Triangle Park, NC

schizophrenia Phase II completed(888) 825-5249

SLV 354 Abbott LaboratoriesAbbott Park, IL


TGOF02N Fabre-Kramer PharmaceuticalsHouston, TX


Vyvanse®


schizophrenia(see also depression, eating, sleep)


zicronapine LundbeckDeerfield, IL




sleep dIsorders


ABT-652(histamine H3 receptor modulator)


excessive daytime sleepiness Phase I completed(847) 937-6100

ADX N05 Aerial BioPharmaMorrisville, NC

excessive daytime sleepiness(see also depression)

Phase II(919) 460-9500

E2006 EisaiWoodcliff Lake, NJ

insomnia Phase I(888) 274-2378

GSK649868(orexin antagonist)


Phase II(888) 825-5249

ITI-007(low-dose formulation)

Intra-Cellular TherapiesNew York, NY

sleep maintenance insomnia(see also schizophrenia)

Phase II(212) 923-3344


sleep disorders in clinical trials(212) 980-9155

Lunesta®

eszopicloneSunovion PharmaceuticalsMarlborough, MA

ADHD-associated insomnia (pediatric)

Phase III completed(508) 481-6700

melatonin controlled-release(orphan Drug)

Neurim PharmaceuticalsTel-Aviv, Israel

sleep disorders Phase IIIwww.neurim.com


insomnia Phase II(800) 672-6372




excessive daytime sleepiness Phase I (800) 672-6372

Neu-P11 Neurim PharmaceuticalsTel-Aviv, Israel

insomnia Phase IIwww.neurim.com

Rozerem®

ramelteonTakeda Pharmaceuticals U.S.A.Deerfield, IL

insomnia (pediatric)(see also depression)

Phase I completed(877) 825-3327

SKP-1041(zaleplon controlled-release)

Somnus TherapeuticsBranchburg, NJ

sleep disorders Phase II completed(908) 901-0300

suvorexant(MK-4305)

MerckWhitehouse Station, NJ

insomnia Phase III(800) 672-6372

tasimelteon Vanda PharmaceuticalsWashington, DC

insomnia(see also depression)

Phase III(202) 734-3400



sleep dIsorders


triazolam intranasal(TGAR01H)

Fabre-Kramer PharmaceuticalsHouston, TX


Vimpat®lacosamide

UCBSmyrna, GA

sleep disorders Phase I(770) 970-7500

Vyvanse®


excessive daytime sleepiness(see also depression, eating, schizophrenia)


zaleplon controlled-release

Intec PharmaJerusalem, Israel

insomnia Phase IIwww.intecpharma.com

zaleplon inhalation(AZ-007)

Alexza PharmaceuticalsMountain View, CA

insomnia Phase I completed(650) 944-7000

Zolpimist™zolpidem buccal spray

NovaDel PharmaBridgewater, NJ

sleep maintenance insomnia Phase I(908) 203-4640

otHer


Abilify®

aripiprazole(once-weekly tablet)

Bristol-Myers SquibbPrinceton, NJOtsuka America PharmaceuticalRockville, MD

Gilles de la Tourette’s syndrome Phase III(800) 332-2056(800) 562-3974

ADX71149(mGluR2-positive allosteric modulator)

Addex PharmaceuticalsGeneva, SwitzerlandJohnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

psychiatric disorders Phase I(800) 817-5286

BI-409306 Boehringer IngelheimPharmaceuticalsRidgefield, CT


BMS-933043(a-7 nicotinic agonist)

Bristol-Myers SquibbPrinceton, NJ




otHer


CORT-108297 Corcept TherapeuticsMenlo Park, CA

weight gain associated with antipsychotics--------------------------------------------------psychiatric disorders

Phase I/II(650) 327-3270-------------------------------------------Phase I(650) 327-3270

ecopipam(PSYRX101)

Psyadon PharmaceuticalsGermantown, MD

Gilles de la Tourette’s syndrome(see also addictive)--------------------------------------------------psychiatric disorders

Phase I/II(301) 919-2020-------------------------------------------Phase I(301) 919-2020

loxapineinhalation(AZ-004)

Alexza PharmaceuticalsMountain View, CA

acute agitation associated with bipolar disorder or schizophrenia

application submitted(650) 944-7000

PH80 Pherin PharmaceuticalsRedwood City, CA

premenstrual dysphoric disorder, premenstrual syndrome


pimavanserin ACADIA PharmaceuticalsSan Diego, CA

Parkinson’s disease-associated psychosis

Phase III(858) 558-2871

The content of this report has been obtained through industry sources and the Adis “R&D Insight” database based on the latest information. Report current as of June 14, 2012. The information may not be comprehensive. For more specific information about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA’s web site.

A publication of phRMA’s Communications & public Affairs Department. (202) 835-3460

www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info | www.sharingmiracles.com

Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.

Copyright © 2012 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given.

Pharmaceutical Research and Manufacturers of America • 950 F Street, NW, Washington, DC 20004


Glossary

anxiety disorders—A group of mental ill-nesses in which symptoms of anxiety (from mild unease to intense fear) are the main feature. Generalized anxiety disorder is diag-nosed if a patient experiences unjustifiable or excessive anxiety and worry, e.g., worry about something bad happening to a loved one (who is not in danger), or worry about money (for no reason) on two or more life circumstances and for six months or longer. A diagnosis of panic disorder requires occurrence of “panic attacks”—sudden feelings of apprehension or fear accompanied by physical symptoms such as shortness of breath—in association with a few concomitant psychological symptoms, that the attacks are severe enough and happen often enough to be disruptive or distressing to the individual, and that at least one attack occurs spontaneously (i.e., in the absence of a fearful stimulus).

application submitted—An application for marketing has been submitted to the U.S. Food and Drug Administration (FDA). The application can either be an NDA (new drug application) or a BLA (biologic license application).

attention deficit/hyperactivity disorder (ADHD)—ADHD is a complex neurological im-pairment that results in an overactive behavior pattern and a difficulty concentrating. While it primarily affects children, a growing number of adults are being diagnosed with the disorder. Boys are affected about three times as often as girls. Children with ADHD are fidgety, impul-sive, reckless, irritable, emotionally immature and sometimes aggressive. Because their attention span is short, they do not conform to orderly routine. ADHD often leads to anti-social acts and difficulty learning, although IQ is nor-mal. No definite cause has been established, but some researchers now believe genetics plays a role.

autism—A complex developmental disorder that causes severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. It is usually first diagnosed in early childhood and ranges from a severe form,

called autism disorder, to a much milder form called Asperger syndrome.

depression—A mental illness characterized by an intense feeling of sadness, which is of greater proportion and duration than expected by objective reason (i.e., recent loss or other sad event). Major depressive disorder (or major depression) includes an episode of depression defined as a persistent (for at least 2 weeks) mood disturbance, plus at least four of the following symptoms: sleep disturbance, changes in psychomotor activity, loss of ability to experience pleasure and interest, fatigue, feelings of worthlessness or guilt, difficulty in concentrating, and/or suicidal thoughts. Major depression is associated with impairment in social functioning. If criteria for major depres-sion have been met but in addition an episode of mania has ever occurred, then the diagnosis becomes bipolar disorder (or manic-depres-sive illness). The essential feature of mania is a distinct period when the mood is either elevated, expansive, or irritable, with associ-ated symptoms including hyperactivity, flight of ideas, inflated self-esteem, decreased need for sleep, distractibility and excessive involvement in activities that often are flamboyant, bizarre or disorganized.

Fast track—Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The status is as-signed by the U.S. Food and Drug Administra-tion. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Generally, determining factors include whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. Once a drug receives Fast Track designation, early and frequent communication between the FDA and

a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, of-ten leading to earlier drug approval and access by patients.

fragile X syndrome (FXS)—The most com-mon inherited mental illness. Impairment can range from learning disabilities to more severe cognitive or intellectual disabilities. FXS is the most common known cause of autism or “autistic-like” behaviors, but up to 85 percent of autism cases are of unknown cause. Symp-toms can also include characteristic physical and behavioral features and delays in speech and language development.

NCe—New chemical entity.

obsessive-compulsive disorder—A psychi-atric condition characterized by recurrent and persistent thoughts that are intense, frighten-ing, absurd or otherwise alien, accompanied by ritualized, repetitive behavior that is usually irrational and bizarre.

orphan Drug—A drug to treat a disease that has a patient population of 200,000 or less, or a disease that has a patient population of more than 200,000 and a development cost that will not be recovered from sales in the United States. Orphan Drug status is assigned by the U.S. Food and Drug Administration.

phase 0—First-in-human trials conducted in accordance with FDA’s 2006 guidance on exploratory Investigational New Drug (IND) studies designed to speed up development of promising drugs by establishing very early whether the tested compound behaves in hu-man subjects as was anticipated from preclini-cal studies.

phase I—Safety testing and pharmacologi-cal profiling of new drugs in small numbers of humans.

phase II—Effectiveness testing and identi-fication of side effect profile of new drugs in humans.


Glossary

phase III—Extensive clinical trials in humans to verify effectiveness and monitor adverse reactions of new drugs.

premenstrual syndrome (PMS)/premenstru-al dysphoric disorder (pMDD)—pMS refers to the variation of physical and mood symp-toms that appear during the last one or two weeks of the menstrual cycle and disappear by the end of a full flow of menses. Psychiatrists and other mental health workers tend to use the term pMDD to describe a specific set of mood symptoms that interfere with social or role functioning that are also present the week

before menses and remit a few days after the start. PMS looks more at physical symptoms such as bloating, breast tenderness and appe-tite change. PMDD has as part of its definition symptoms such as depressed mood, anxiety or tension, irritability, concentration difficul-ties, overeating or food cravings, and feeling overwhelmed.

psychosis—Severe mental disorders in which the individual loses contact with reality. Symptoms include delusions, hallucinations, thought disorders, loss of emotion, mania and depression.

schizophrenia—The most common form of psychotic illness characterized by disturbances in thinking, emotional reaction and behavior. It is disabling and has a prolonged course that almost always results in chronic ill health and some degree of personality change.


Selected Facts about Mental Illnesses and Addictive Disorders

• An estimated 450 million people worldwide have a mental disorder. At any given time, approximately 10 percent of adults are experiencing a current mental disorder, and 25 percent will develop one at some point during their lifetimes.1

• Mental disorders account for 13 percent of the global burden of disease, and that figure will rise to nearly 15 percent by 2030. Depression alone is likely to be the second highest contributor to the global burden of disease by that date.1

• Suicide is among the top 20 leading causes of death globally for all ages. Mental disorders are associated with more than 90 percent of the 1 million suicides that occur annually. On average, almost 3,000 people commit suicide daily.1

• Mental disorders are common both in the United States and internationally. An estimated 26.2 percent of Americans ages 18 and older—about 1 in 4 adults—suffer from a diagnosable mental disorder in a given year. That’s 57.7 million people with a diagnosable mental disorder in a year. In addition, an estimated 4 million American children and adolescents suffer from a severe mental illness. While mental disorders are widespread in the population, the main burden of illness is concentrated in a much smaller proportion of the population; about 6 percent, or 1 in 17 Ameri-cans, suffer from a serious mental illness.2

• Mental disorders are the leading cause of disability in the United States and Canada for people ages 15 to 44. Many people suffer from more than one mental disorder at a given time. Nearly half (45 percent) of those with any mental disorder meet criteria for two or more disorders.2

• Suicide is a major, preventable public health problem. In 2007, it was the tenth leading cause of death in the United States, accounting for 34,598 deaths. The overall rate was 11.3 suicide deaths per 100,000 people. Risk factors for suicide include depression and other mental dis-orders or a substance-abuse disorder (often in combination with other mental disorders). More than 90 percent of people who die by suicide have those risk factors.2

• An estimated 11 attempted suicides occur for every suicide death. Men are more likely to die by suicide than women, but women are more likely to attempt suicide. Men are more likely to use deadlier methods, such as firearms or suffocation, while women are more likely to attempt suicide by poisoning.2

• Year after year, suicide remains one of the top three leading causes of death for young people ages 15 to 24. Older adults are at risk for suicide, too. White males age 85 and older consistently have the highest suicide rate than any other age and ethnic group.2

• Serious mental illnesses cost the United States more than $317 billion in lost wages, health care expenditures, and disability benefits each year.2

• Slightly more than half (51.8 percent) of Americans ages 12 or older reported being current drinkers of alcohol in the 2010 National Survey on Drug Use and Health (NSDUH), an annual survey sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA). That translates to an estimated 131.3 million people. In 2010, nearly one-quarter (23.1 percent) of people ages 12 or older—about 58.6 million people--participated in binge drinking. Also in 2010, heavy drinking was reported by 6.7 percent of that population, or 16.9 million people.3

• In 2010, an estimated 22.6 million Americans ages 12 or older were current (past month) illicit drug users. That estimate represents 8.9 percent of the population ages 12 or older. Illicit drugs include marijuana/hashish, cocaine (including crack), heroin, hallucinogens, inhalants, or prescrip-tion-type psychotherapeutics used non-medically.3

• In 2010, an estimated 22.1 million people (8.7 percent of the population ages 12 or older) were classified with substance dependence or abuse in the past year. Of those, 2.9 million were classified with dependence or abuse of both alcohol and illicit drugs, 4.2 million had dependence or abuse of illicit drugs but not alcohol, and 15.0 million had dependence or abuse of alcohol but not illicit drugs.3

Overview

Addictive Disorders


• Anxiety disorders, which include panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and phobias, affect some 40 million adults ages 18 and older, or about 18 percent of people in that age group in a given year.

• Generalized anxiety disorder (GAD) affects about 6.8 million American adults, including twice as many women as men. The disorder develops gradually and can begin at any point in life, although the years of highest risk are between childhood and middle age.

• obsessive-compulsive disorder (oCD) affects about 2.2 million American adults, striking men and women in roughly equal numbers. OCD usually appears in childhood, adolescence, or early adulthood. One-third of adults with OCD develop symptoms as children, and research indi-cates that OCD might run in families.

• panic disorder affects about 6 million American adults and is twice as common in women as men. Panic attacks often begin in late adolescence or early adulthood.

• post-traumatic stress disorder (ptSD) affects about 7.7 million American adults, but it can occur at any age, including childhood. Women are more likely to develop PTSD than men, and there is some evidence that susceptibility to the disorder may run in families.

• Social phobia affects about 15 million American adults. Women and men are equally likely to develop the disorder, which usually begins in childhood or early adolescence.

Anxiety Disorders2

Addictive Disorders (continued)


• The estimated economic cost of alcohol abuse in 1998 was $184.6 billion, or $638 for every man, woman, and child in the United States. Alcohol-related injuries alone cost an estimated $47 billion annually.4

• Illicit drug use in the United States is estimated to have cost the U.S. economy more than $193 billion in 2007, according to a study produced by the National Drug Intelligence Center (NDIC).5

Attention-Deficit/Hyperactivity Disorder (ADHD)6

Autism7

• Attention-deficit/hyperactivity disorder (ADHD) is one of the most common reasons children are referred for mental health services. It affects as many as one in every 20 children, and boys are three to four times more likely than girls to experience the disorder. Although most children with ADHD have normal or above-normal intelligence, 40 percent to 60 percent have serious learning difficulties.

• Children and adolescents with ADHD are more likely than children without the disorder to suffer from other mental disorders. About one-half of all young people with ADHD have oppositional defiant disorder; about one-quarter have an anxiety disorder; as many as one-third have depression; and one-fifth have bipolar disorder. Adolescents with untreated ADHD are at risk for substance abuse disorders.

• Autism spectrum disorders (ASDs) are a group of developmental disabilities that can cause significant social, communication and behavioral challenges. The U.S. Centers for Disease Control and Prevention (CDC) estimates that about 1 in 88 children has been identified with an ASD. ASDs are reported in all racial, ethnic, and socioeconomic groups. They are almost five times more common among boys (1 in 54) than among girls (1 in 252).


• Mood disorders, which include major depressive disorder, dysthymic disorder, and bipolar disorder, affect nearly 21 million adults, or about 9.5 percent of the U.S. population age 18 and older in a given year.2

• Bipolar disorder often develops in a person’s late teens or early adult years. At least half of all cases start before age 25. Some people have their first symptoms during childhood, while others may develop symptoms late in life.2

• Depression can strike anyone regardless of age, ethnic background, socioeconomic status, or gender; however, studies have found that depression is about twice as common in women as in men. In any given one year period, depressive illnesses affect 12 percent of women (more than 12 million women) and nearly 7 percent of men (more than 6 million men).2

• Dysthymic disorder, which is characterized by chronic low-level depression, affects approximately 1.5 percent of the adult population in the United States.2

• Both dysthymic disorder and major depressive disorder together have affected approximately 11.2 percent of 13- to 18-year olds in the United States at some point during their lives. Girls are more likely than boys to experience depressive disorders. Additionally, 3.3 percent of 13- to 18-year olds have experienced a seriously debilitating depressive disorder.2

• Major depressive disorder is, by itself, the leading cause of disability among Americans ages 15-44. It affects 6.7 percent of the U.S. adult population.2

• Bipolar disorder costs twice as much in lost productivity as major depressive disorder, according to a study by the National Institute of Mental Health (NIMH). Each U.S. worker with bipolar disorder averaged 65.5 lost workdays in a year, compared to 27.2 for major depression. Even though major depression is more than six times as prevalent, bipolar disorder costs the U.S. workplace nearly half as much—a disproportionate-ly high $14.1 billion in lost salary-equivalent productivity compared to $36.6 billion for major depression annually. Researchers traced the higher toll mostly to bipolar disorder’s more severe depressive episodes rather than to its agitated manic periods.2

• Clinical depression has become one of America’s most costly illnesses. Left untreated, depression is as costly as heart disease or AIDS to the U.S. economy, costing over $51 billion in absenteeism from work and lost productivity and $26 billion in direct treatment costs. Depression tends to affect people in their prime working years and may last a lifetime if untreated. More than 80 percent of people with clinical depression can be successfully treated.6

Depression


• eating disorders are more common in women. The lifetime rate for anorexia nervosa among women is estimated at 0.9 percent compared to 0.3 percent among men. The lifetime rate among women for bulimia nervosa is 0.5 percent compared to 0.1 percent among men. And the life-time rate among women for binge-eating disorder is 3.5 percent compared to 2 percent among men. Some researchers believe those numbers are under-estimates, in part because hospitalization rates for eating disorders continue to rise, increasing 18 percent between 1999 and 2006.

eating Disorders2

• premenstrual syndrome (pMS) is estimated to affect up to 75 percent of women during their childbearing years. It occurs more often in women between their late 20s and early 40s, those with at least one child, those with a family history of major depression, or women with a past medi-cal history of either postpartum depression or an affective mood disorder. Up to 60 percent of women with severe PMS have an underlying psychiatric disorder.

• premenstrual dysphoric disorder (pMDD), a very severe form of PMS, affects between 3 percent to 8 percent of menstruating women.

premenstrual Disorders2


• Schizophrenia affects about 1 percent of the American population and affects men and women equally. It occurs at similar rates in all ethnic groups around the world. Symptoms such as hallucinations and delusions usually start between the ages of 16 and 30. Men tend to experience symptoms a little earlier than women. Most of the time, people do not get schizophrenia after age 45.2

• The appearance of schizophrenic symptoms before age 12 is rare—less than one-sixtieth as common as the adult-onset type. Neurodevel-opmental damage seems to be greater in childhood schizophrenia than in the adult-onset type. Most schizophrenic children show delays in language and other functions long before their psychotic symptoms (hallucinations, delusions, and disordered thinking) appear, usually at age 7 or later. In the first years of life, about 30 percent of those children have transient symptoms of pervasive developmental disorder, such as rock-ing, posturing, and arm flapping.6

• Schizoaffective disorder, a combination of symptoms of schizophrenia and a mood disorder, may range from 2 to 5 in 1,000 people (i.e., 0.2 percent to 0.5 percent) and may account for one-fourth or even one-third of all people with schizophrenia.8

Schizophrenia


Sources:

1. World Health Organization, www.who.int

2. National Institute of Mental Health, www.nimh.nih.gov

3. Substance Abuse and Mental Health Services Administration, www.samhsa.gov

4. Community Safety Services, www.be-safe.org

5. U.S. Department of Justice, www.usdoj.gov

6. Mental Health America, www.mentalhealthamerica.net

7. U.S. Centers for Disease Control and Prevention, www.cdc.gov

8. National Alliance on Mental Illness, www.nami.org

the U.S. system of new drug approvals is perhaps the most rigorous in the world.It takes 10-15 years, on average, for an experimental drug to travel from lab to U.S. patients, according to the Tufts Center for the Study of Drug Development. Only five in 5,000 compounds that enter preclinical testing make it to human testing. And only one of those five is approved for sale.On average, it costs a company $1.2 billion, including the cost of failures, to get one new medicine from the laboratory to U.S. patients, according to a 2007 study by the Tufts Center for the Study of Drug Development.Once a new compound has been identified in the laboratory, medicines are usually devel-oped as follows:preclinical testing. A pharmaceutical com-pany conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the com-pound is evaluated for safety.Investigational New Drug Application (IND). After completing preclinical testing, a company files an IND with the U.S. Food and Drug

Administration (FDA) to begin to test the drug in people. The IND shows results of previous experiments; how, where and by whom the new studies will be conducted; the chemical structure of the compound; how it is thought to work in the body; any toxic effects found in the animal studies; and how the compound is manufactured. All clinical trials must be reviewed and approved by the Institutional Review Board (IRB) where the trials will be conducted. Progress reports on clinical trials must be submitted at least annually to FDA and the IRB.Clinical trials, phase I. These tests usually involve about 20 to 100 healthy volunteers. The tests study a drug’s safety profile, including the safe dosage range. The studies also determine how a drug is absorbed, distributed, metabo-lized, and excreted as well as the duration of its action.Clinical trials, phase II. In this phase, controlled trials of approximately 100 to 500 volunteer patients (people with the disease) assess a drug’s effectiveness and determine the early side effect profile.Clinical trials, phase III. This phase usually involves 1,000 to 5,000 patients in clinics and

hospitals. Physicians monitor patients closely to confirm efficacy and identify adverse events. New Drug Application (NDA)/Biologic License Application (BLA). Following the completion of all three phases of clinical trials, a company analyzes all of the data and files an NDA or BLA with FDA if the data successfully demonstrate both safety and effectiveness. The applications contain all of the scientific information that the company has gathered. Applications typically run 100,000 pages or more.Approval. Once FDA approves an NDA or BLA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional trials (Phase IV) to evaluate long-term effects. Discovering and developing safe and effective new medicines is a long, difficult, and expensive process. PhRMA member companies invested an estimated $49.5 billion in research and development in 2011.

The Drug Discovery, Development and Approval Process

Developing a new medicine takes an average of 10-15 years; For every 5,000-10,000 compounds in the pipeline, only 1 is approved.

The Drug Development and Approval Process

Medicines in Development for Mental Illnesses

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