2012 REPO Medicines in Development MENTAL ILLNESSES R PRESENTED BY AMERICA’S BIOPHARMACEUTICAL T RESEARCH COMPANIES Pharmaceutical Research Companies Are Developing Nearly 200 Medicines to Treat Mental Illnesses and Addictive Disorders ADDICTIVE DISORDERS ANXIETY DISORDERS ATTENTION-DEFICIT/HYPERACTIVITY DISORDERER DEPRESSION DEVELOPMENTAL DISORDERS EATING DISORDERS PERSONALITY DISORDERS Medicines in Development SCHIZOPHRENIA For Selected Mental Illnesses SSLEEEP DISORDERS And Addictive Disorders 1 in 4 American adults suffer from a 52 diagnosable mental illness America’s biopharmaceutical research com- annually in lost wages, health care expendi- panies are developing 187 medicines to help tures, and disability benefits. the nearly 60 million American adults now suf- 36 Examples of some medicines now being fering from some form of mental illness—from tested to treat mental illnesses include: anxiety to depression and from schizophrenia to addictive disorders, such as dependence • A medicine to potentially treat the various on alcohol or drugs. All of the medicines are symptoms associated with schizophrenia, 26 26 either in clinical trials or awaiting review by with diminished side effects. the Food and Drug Administration. Over the • An intranasal medicine for the treatment past half century, biopharmaceutical research of anxiety which has shown to improve has helped transform mental illnesses from symptoms within several minutes of misunderstood causes of shame and fear into administration. often highly treatable conditions. For example, Researching and developing new medicines medicines for treating depression are helping remains a risky investment and lengthy thousands of people live productive lives and process. But advances in our understanding breakthrough schizophrenia medicines have of mental illnesses and how to treat them have enabled patients to be treated in the commu- allowed America’s biopharmaceutical com- nity rather than being institutionalized. panies to conduct the cutting-edge research Despite such progress, mental illnesses con- needed to reduce the destructive toll of these tinue to exact a heavy human and economic disorders and to allow more patients to lead s s toll. The National Institute of Mental Health healthier, happier, more productive lives. (NIMH) estimates that 1 in 4 American adults Anxiety Addictive Disorder Disorder suffer from a diagnosable mental disorder. Ac- Depression cording to the NIMH, serious mental illnesses Schizophrenia cost the United States more than $317 billion Medicines in Development for Mental Illnesses Medicines in Development for Mental Illnesses* Addictive Disorders 26 Anxiety Disorders 26 Attention-Deficit/ Hyperactivity Disorder 20 Cognition Disorders 10 Depression 52 Developmental Disorders 10 Eating Disorders 3 Schizophrenia 36 Sleep Disorders 22 Other 9 * Some medicines are in development for more than one disorder. ADDICTIVE DISORDERS Product Name Sponsor Indication Development Status* ALKS33 Alkermes drug dependence Phase I (samidorphan) Cambridge, MA (617) 494-0171 ALKS5461 Alkermes cocaine dependence Phase I (buprenorphine/samidorphan) Cambridge, MA (see also depression) (617) 494-0171 ARD-1600 Aradigm smoking dependence Phase I (nicotine inhalation) Hayward, CA (510) 265-9000 buprenorphine/naloxone Orexo opioid dependence Phase III fixed-dose combination Uppsala, Sweden www.orexo.com buprenorphine/naloxone BioDelivery Sciences International opioid dependence Phase I transmucosal Raleigh, NC (919) 582-9050 Ch-mAb7F9 InterveXion drug dependence Phase I Little Rock, AR (501) 554-2377 *For more information about a specific medicine in this report, please call the telephone number listed. 2 Medicines in Development Mental Illnesses 2012 Medicines in Development for Mental Illnesses ADDICTIVE DISORDERS Product Name Sponsor Indication Development Status CPP-109 Catalyst Pharmaceutical alcohol dependence, Phase II (vigabatrin) Coral Gables, FL cocaine dependence (305) 529-2522 (Fast Track) ecopipam Psyadon Pharmaceuticals pathological gambling Phase II (PSYRX101) Germantown, MD (see also other) (301) 919-2020 EMB-001 Embera NeuroTherapeutics cocaine dependence Phase I completed Shreveport, LA (318) 213-0198 GSK561679 GlaxoSmithKline stress-related alcohol abuse Phase II (verucerfont) Rsch. Triangle Park, NC (see also anxiety) (888) 825-5249 ibudilast MediciNova methamphetamine dependence Phase I (MN-166/AV11) San Diego, CA (858) 373-1500 INT-0003/2005 Cary Pharmaceuticals nicotine dependence Phase I Great Falls, VA (703) 759-7460 IntelGenx (514) 331-7440 Quebec, Canada KRL-901 Krele Pharmaceuticals alcohol dependence in clinical trials (TONIX Pharmaceuticals) (212) 908-9155 New York, NY lofexidine US WorldMeds opioid dependence Phase III Louisville, KY (502) 753-2094 MT-7716 Mitsubishi Tanabe Pharma alcohol dependence Phase I Development America (908) 607-1950 Warren, NJ NanoBUP™ Nanotherapeutics opioid dependence Phase I completed buprenorphine/naloxone Alachua, FL (386) 462-9663 neboglamine Rottapharm | Madaus cocaine dependence Phase II (CR-224) Monza, Italy www.rotta.com nepicastat oral Biotie Therapies cocaine dependence Phase II completed (SYN117) South San Francisco, CA (see also anxiety) (650) 244-4850 NIC002 Novartis Pharmaceuticals nicotine dependence Phase II East Hanover, NJ (888) 669-6682 NicVAX™ GlaxoSmithKline nicotine dependence (Fast Track) Phase III nicotine abuse vaccine Rsch. Triangle Park, NC (888) 825-5249 Nabi Biopharmaceuticals (800) 685-5579 Rockville, MD Medicines in Development Mental Illnesses 2012 3 Medicines in Development for Mental Illnesses ADDICTIVE DISORDERS Product Name Sponsor Indication Development Status OMS-403 Omeros nicotine dependence, Phase II Seattle, WA opioid dependence (206) 676-5000 New York State Psychiatric Institute New York, NY Probuphine® Titan Pharmaceuticals opioid dependence Phase III bupenorphine implant South San Francisco, CA (650) 244-4990 Sabril® Lundbeck cocaine dependence (Fast Track) Phase II vigabatrin Deerfield, IL (866) 337-6996 -------------------------------------------------- ------------------------------------------- methamphetamine addiction Phase I (866) 337-6996 SEL-068 Selecta Biosciences smoking dependence Phase I Watertown, MA (617) 923-1400 TA-CD Celtic Pharma cocaine dependence Phase II (cocaine abuse vaccine) Hamilton, Bermuda www.celticpharma.com X-22 22nd Century Group smoking dependence Phase II Westport, CT (203) 222-7399 ANXIETY DISORDERS Product Name Sponsor Indication Development Status ABT-436 Abbott Laboratories anxiety Phase I (vasopressin-1b receptor Abbott Park, IL (see also depression) (847) 937-6100 antagonist) alprazolam sublingual Pfizer anxiety Phase I completed New York, NY (860) 732-5156 alprazolam transdermal Nuvo Research panic disorder Phase I Mississauga, Canada (905) 673-6980 AVN 101 Avineuro Pharmaceuticals anxiety Phase II (serotonin 6 receptor San Diego, CA (858) 436-1537 antagonist) AVN 397 Avineuro Pharmaceuticals anxiety Phase II San Diego, CA (858) 436-1537 BNC210 Bionomics anxiety Phase I completed Adelaide, Australia (617) 621-7722 Ironwood Pharmaceuticals Cambridge, MA 4 Medicines in Development Mental Illnesses 2012 Medicines in Development for Mental Illnesses ANXIETY DISORDERS Product Name Sponsor Indication Development Status carvedilol Columbia Northwest Pharmaceuticals post-traumatic stress disorder Phase II Bellevue, WA (877) 453-0404 CX157 CeNeRx Pharma anxiety Phase I Cary, NC (see also depression) (919) 234-4072 CXB722 CeNeRx BioPharma anxiety Phase II (pivagabine prodrug) Cary, NC (see also depression) (919) 234-4072 Cymbalta® Eli Lilly generalized anxiety disorder Phase III duloxetine Indianapolis, IN (pediatric) (800) 545-5979 (see also depression) ganaxolone Marinus Pharmaceuticals post-traumatic stress disorder Phase II Branford, CT (203) 315-0566 GSK561679 GlaxoSmithKline post-traumatic stress disorder Phase II (verucerfont) Rsch. Triangle Park, NC (see also addictive) (888) 825-5249 INTUNIV™ Shire Pharmaceuticals anxiety disorders (pediatric), Phase II guanfacine Wayne, PA generalized anxiety disorder www.shire.com extended-release (pediatric), social phobia (pediatric) KRL-104 Krele Pharmaceuticals generalized anxiety disorder in clinical trials (TONIX Pharmaceuticals) (212) 908-9155 New York, NY nepicastat oral Biotie Therapies post-traumatic stress disorder Phase II (SYN117) South San Francisco, CA (see also addictive) (650) 244-4850 PH94B Pherin Pharmaceuticals generalized social phobia Phase II Los Altos, CA (650) 961-2703 PRX-3140 Nanotherapeutics post-traumatic stress disorder Phase II Alachua, FL (386) 462-9663 SPN-805 Supernus Pharmaceuticals anxiety Phase I Rockville, MD (301) 838-2500 SPN-808 Supernus Pharmaceuticals anxiety Phase I Rockville, MD (301) 838-2500 SRX246 Azevan Pharmaceuticals traumatic stress disorder Phase I Bethlehem, PA (610) 419-1057 Medicines in Development Mental Illnesses 2012 5 Medicines in Development for Mental Illnesses ANXIETY DISORDERS Product Name Sponsor Indication Development Status tedatioxetine Lundbeck generalized anxiety disorder Phase I Deerfield, IL (see also depression) (866) 337-6996 Takeda Pharmaceuticals U.S.A. (877) 825-3327 Deerfield, IL TGFK08AA Fabre-Kramer Pharmaceuticals generalized anxiety disorder Phase II Houston, TX (713) 975-6900 TGWOOAA Fabre-Kramer Pharmaceuticals generalized anxiety disorder, Phase II Houston, TX social phobia (713) 975-6900 TO-2061 Transcept Pharmaceuticals obsessive-compulsive disorder Phase II (ondansetron/risperidone) Pt. Richmond, CA (510)