美国2000年开发中的精神病新药

2000 Mental Illnesses N E W M E D I C I N E S I N D E V E L O P M E N T F O R Survey P R E S E N T E D B Y A M E R I C A ’ S P H A R M A C E U T I C A L C O M P A N I E S One hundred and three medicines are in the pharma-ceutical pipeline to help the more than 50 millionAmericans who suffer from some form of mental illness—from Alzheimer’s disease to depression to schizo- phrenia to substance dependence. Over the past half-century, pharmaceutical research has helped transform mental illness from a misunderstood cause of shame and fear into a highly treatable condition. Medicines for depression are helping many thousands of people with this disease to be productive workers and responsible family members. Breakthrough medicines for schizophrenia enable most patients to be treated in the community. And medi- cines for Alzheimer’s are helping elderly people stay out of nursing homes. Twenty-six of the potential medicines target depression, which afflicts some 19 million Americans and costs the economy an estimated $44 billion a year, including $12 billion in lost work days. Alzheimer’s disease and other dementias are the focus of 24 of the medicines in development. More than 4 million Americans suffer from Alzheimer’s disease, which costs about $100 billion each year. The incidence and expense of Alzheimer’s are expected to triple in the next 20 years as the population ages. Sixteen medicines are in the pipeline for schizophrenia, which affects more than 2 million Americans and costs more than $30 billion a year. Substance use disorders, which cost U.S. society nearly $400 billion a year, are the target of 21 new medicines, many of which are being developed by the National Institute on Drug Abuse. Thirteen of the medicines target anxiety disorders, the most common mental illness in the United States. More than 19 million Americans are affected by these debilitating disorders, which account for nearly one-third of the nation’s annual $148 billion mental health bill. Other medicines are being developed to treat attention deficit/hyperactivity disorder, eating disorders, post-traumatic stress disorder, premenstrual disorders, sexual disorders and other problems with mental symptoms. Many of the medicines in the pipeline attack mental ill- nesses in new ways. For example: • A potential medicine for Alzheimer’s has a dual mechanism of action. Like medicines currently on the market, it inhibits an enzyme that breaks down a critical chemical messenger in the brain called acetylcholine. But the new medicine also acts on key receptors in the brain that could lead to the release of more acetylcholine. • A medicine in development for both Alzheimer’s disease and schizophrenia is designed to increase the strength of signals at connections between brain cells. The weakening or loss of these connections is thought to be responsible for memory difficulties in Alzheimer’s patients and to contribute to cognitive dysfunction in schizophrenia. • A medicine being tested for attention deficit/hyperactivity disorder blocks a receptor that releases histamine—a sub- stance that depresses levels of alertness. By blocking the release of histamine, researchers hope to increase levels of alertness. The medicine may also be developed for dementias and sleep disorders. This year, pharmaceutical companies will spend an esti- mated $6 billion to discover and develop medicines for diseases of the central nervous system, including mental ill- nesses. This ongoing commitment and the 103 medicines for mental illnesses now in clinical trials or awaiting approval by the Food and Drug Administration offer hope of reducing the terrible human and economic toll of mental illnesses. Alan F. Holmer President and CEO PhRMA Survey Finds 103 Medicines in Clinical Testing for Mental Illnesses Other Disorders Substance Use Disorders Schizophrenia Premenstrual Disorders Attention Deficit/ Hyperactivity Disorder Eating Disorders Depression Dementias Anxiety Disorders 13 10 24 26 5 3 Post-Traumatic Stress Disorder 2 16 21 2 Sexual Disorders 3 * Some medicines are in development for more than one disorder. MEDICINES IN DEVELOPMENT FOR MENTAL ILLNESSES* New Medicines in Development for Mental Illnesses A N X I E T Y D I S O R D E R S Product Name Company Indication Development Status BuSpar® Bristol-Myers Squibb anxiety application submitted buspirone Princeton, NJ -------------------------------------------------------------------------------------- hydrochloride anxiety (pediatric) Phase III CGP 60829 Novartis Pharmaceuticals panic disorder, social phobia Phase II East Hanover, NJ (see also depression) DU 127090 Solvay Pharmaceuticals psychosis Phase II Marietta, GA flesinoxan Solvay Pharmaceuticals generalized anxiety disorder Phase III Marietta, GA (see also depression) fluvoxamine Solvay Pharmaceuticals obsessive-compulsive disorder, Phase III controlled-release Marietta, GA social anxiety disorder LU 28-179 Forest Laboratories generalized anxiety disorder Phase II New York, NY NGD 91-3 Neurogen anxiety Phase I Branford, CT Pfizer New York, NY pagodone Interneuron panic disorder Phase III Pharmaceuticals Lexington, MA Warner-Lambert Morris Plains, NJ Paxil® SmithKline Beecham generalized anxiety disorder application submitted paroxetine Philadelphia, PA (see also post-traumatic stress hydrochloride disorder, premenstrual disorders) Prozac® Eli Lilly panic disorder Phase III fluoxetine Indianapolis, IN (see also post-traumatic stress disorder, premenstrual disorders) SB 243213 SmithKline Beecham anxiety Phase I Philadelphia, PA (see also depression) SR 142801 Sanofi-Synthelabo phobias Phase II NK3 receptor New York, NY (see also depression, schizophrenia) antagonist substance P Merck anxiety Phase II antagonist Whitehouse Station, NJ (see also depression, other) A T T E N T I O N D E F I C I T / H Y P E R A C T I V I T Y D I S O R D E R Product Name Company Indication Development Status Aricept® Eisai attention deficit/hyperactivity Phase I donepezil Teaneck, NJ disorder hydrochloride (see also dementias) Concerta™ Alza and Crescendo attention deficit/hyperactivity application submitted OROS® Pharmaceuticals disorder methylphenidate Mountain View, CA 2 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 A T T E N T I O N D E F I C I T / H Y P E R A C T I V I T Y D I S O R D E R Product Name Company Indication Development Status d-threo- Celgene attention deficit/hyperactivity Phase III completed methylphenidate Warren, NJ disorder hydrochloride GW320659 Glaxo Wellcome attention deficit/hyperactivity Phase II noradrenaline/ Rsch. Triangle Park, NC disorder dopamine (see also other) reuptake inhibitor Inversine® Layton Biosciences attention deficit/hyperactivity Phase II mecamylamine Sunnyvale, CA disorder hydrochloride (see also substance use disorders) (Orphan Drug) MethylPatch Noven Pharmaceuticals attention deficit/hyperactivity Phase III methylphenidate Miami, FL disorder transdermal system Perceptin Gliatech attention deficit/hyperactivity Phase II Cleveland, OH disorder Provigil® Cephalon attention deficit/hyperactivity Phase I/II modafinil West Chester, PA disorder Ritalin® QD Tablet Novartis Pharmaceuticals attention deficit/hyperactivity Phase III methylphenidate East Hanover, NJ disorder hydrochloride tomoxetine Eli Lilly attention deficit/hyperactivity Phase III Indianapolis, IN disorder D E M E N T I A S Product Name Company Indication Development Status ALCAR Sigma-Tau Alzheimer’s disease in early Phase III acetyl-l-carnitine Pharmaceuticals onset patients HCl Gaithersburg, MD Ampalex™ Cortex Pharmaceuticals Alzheimer’s disease Phase II Irvine, CA (see also schizophrenia) AN-1792 Elan Pharmaceuticals Alzheimer’s disease Phase I S. San Francisco, CA Aricept® Eisai Alzheimer’s disease Phase III donepezil Teaneck, NJ (see also attention deficit/hyperactivity hydrochloride disorder) CI-1017 Warner-Lambert Alzheimer’s disease Phase I Morris Plains, NJ DP 543 Du Pont Pharmaceuticals Alzheimer’s disease Phase II Wilmington, DE M2 antagonist Schering-Plough Alzheimer’s disease Phase I Madison, NJ Marinol Unimed Pharmaceuticals Alzheimer’s disease Phase II Buffalo Grove, IL and disturbed behavior 3N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 D E M E N T I A S Product Name Company Indication Development Status memantine Neurobiological Alzheimer’s disease Phase III completed Technologies Richmond, CA NDD 094 Novartis Pharmaceuticals Alzheimer’s disease Phase II East Hanover, NJ Neotrofin™ NeoTherapeutics Alzheimer’s disease Phase II leteprinim Irvine, CA potassium, AIT-082 NGD 97-1 Neurogen Alzheimer’s disease Phase I Branford, CT Pfizer New York, NY peptide T Advanced Immune T AIDS dementia Phase IV (intranasal) St. James, NY Premarin® Wyeth-Ayerst Laboratories Alzheimer’s disease Phase III conjugated Philadelphia, PA estrogens Reminyl® Janssen Pharmaceutica Alzheimer’s disease application submitted galantamine Titusville, NJ tablets Risperdal® Janssen Pharmaceutica psychotic and related disorders application submitted risperidone Titusville, NJ in dementia (see also depression) SB 271046 SmithKline Beecham cognition enhancement Phase I 5HT VI antagonist Philadelphia, PA SL 25.1188 Sanofi-Synthelabo Alzheimer’s disease Phase I New York, NY (see also substance use disorders) SR 57667 Sanofi-Synthelabo Alzheimer’s disease Phase I New York, NY SR 57746 Sanofi-Synthelabo Alzheimer’s disease Phase II neurotrophic New York, NY SR 141716 Sanofi-Synthelabo Alzheimer’s disease Phase II cannabinoid New York, NY (see also eating disorders, receptor schizophrenia, substance use (CB1) antagonist disorder) talsaclidine Boehringer Ingelheim Alzheimer’s disease Phase II Pharmaceuticals Ridgefield, CT Vioxx® Merck Alzheimer’s disease Phase V rofecoxib Whitehouse Station, NJ Zyprexa® Eli Lilly Alzheimer’s psychoses/dementia Phase III olanzapine Indianapolis, IN (see also depression) 4 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 D E P R E S S I O N Product Name Company Indication Development Status CGP 60829 Novartis Pharmaceuticals major depressive disorder Phase II East Hanover, NJ (see also anxiety) duloxetine Eli Lilly major depressive disorder Phase II Indianapolis, IN flesinoxan Solvay Pharmaceuticals depression Phase III Marietta, GA (see also anxiety) flibanserin Boehringer Ingelheim major depressive disorder Phase II Pharmaceuticals Ridgefield, CT gepirone Organon depression Phase III West Orange, NJ Lamictal® Glaxo Wellcome bipolar disorder (manic-depressive) Phase III lamotrigine Rsch. Triangle Park, NC Luvox® Solvay Pharmaceuticals depression application submitted fluvoxamine Marietta, GA NS2389 Glaxo Wellcome depression Phase II mixed monoamine Rsch. Triangle Park, NC reuptake inhibitor OPC-14523 Otsuka America major depressive disorder Phase II Pharmaceutical Rockville, MD ORG 12962 Organon depression Phase II West Orange, NJ ORG 34167 Organon depression Phase I West Orange, NJ ORG 34517 Organon depression Phase II West Orange, NJ (R)-didesmethyl- Sepracor major depressive disorder Phase I sibutramine Marlborough, MA (R)-fluoxetine Eli Lilly major depressive disorder Phase II Indianapolis, IN Sepracor Marlborough, MA Risperdal® Janssen Pharmaceutica bipolar disorder (manic-depressive) Phase III risperidone Titusville, NJ (see also dementias) SB 243213 SmithKline Beecham depression Phase I Philadelphia, PA (see also anxiety) (S)-citalopram Forest Laboratories depression Phase III New York, NY Serzone-ER Bristol-Myers Squibb depression Phase III nefazodone Princeton, NJ (extended-release capsule) SL 92.0679 Sanofi-Synthelabo depression Phase III befloxatone New York, NY (see also substance use disorders) 5N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 D E P R E S S I O N Product Name Company Indication Development Status SR 58611 Sanofi-Synthelabo major depressive disorder Phase II B3 adreneugic New York, NY receptor agonist SR 142801 Sanofi-Synthelabo major depressive disorder Phase II NK3 receptor New York, NY (see also anxiety, schizophrenia) antagonist substance P Merck depression Phase II antagonist Whitehouse Station, NJ (see also anxiety, other) topiramate R.W. Johnson bipolar disorder (manic-depressive) Phase II Pharmaceutical Research Institute Raritan, NJ Vestra Pharmacia depression application submitted reboxetine Peapack, NJ YKP-10-A SkyePharma depression Phase II San Diego, CA Zyprexa® Eli Lilly bipolar depression and mood Phase III olanzapine Indianapolis, IN stabilization (see also dementias) E A T I N G D I S O R D E R S Product Name Company Indication Development Status Axokine Emisphere Technologies obesity Phase II Tarrytown, NY Regeneron Pharmaceuticals Tarrytown, NY ecopipam Schering-Plough obesity Phase II Madison, NJ leptin Amgen obesity Phase II Thousand Oaks, CA RF-1051 SuperGen obesity Phase II San Ramon, CA SR 141716 Sanofi-Synthelabo obesity Phase II cannabinoid New York, NY (see also dementias, schizophrenia, receptor substance use disorders) (CB1) antagonist P O S T - T R A U M A T I C S T R E S S D I S O R D E R Product Name Company Indication Development Status Paxil® SmithKline Beecham post-traumatic stress disorder Phase III paroxetine Philadelphia, PA (see also anxiety, premenstrual hydrochloride disorders) Prozac® Eli Lilly post-traumatic stress disorder Phase III fluoxetine Indianapolis, IN (see also anxiety, premenstrual disorders) 6 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 P R E M E N S T R U A L D I S O R D E R S Product Name Company Indication Development Status ORG 39479/PH80 Organon premenstrual syndrome Phase I West Orange, NJ Pherin Pharmaceuticals Menlo Park, CA Paxil® SmithKline Beecham premenstrual dysphoric disorder Phase III paroxetine Philadelphia, PA (see also anxiety, post-traumatic hydrochloride stress disorder) Prozac® Eli Lilly premenstrual dysphoric disorder Phase III fluoxetine Indianapolis, IN (see also anxiety, post-traumatic stress disorder) S C H I Z O P H R E N I A Product Name Company Indication Development Status Ampalex™ Cortex Pharmaceuticals schizophrenia Phase II Irvine, CA (see also dementias) aripiprazole Bristol-Myers Squibb schizophrenia Phase III (OPC-14597) Princeton, NJ Otsuka America Pharmaceutical Rockville, MD ORG 5222 Organon schizophrenia Phase II West Orange, NJ ORG 23430 Organon schizophrenia Phase II West Orange, NJ ORG 24448/Cx619 Cortex Pharmaceuticals schizophrenia Phase I Irvine, CA Organon West Orange, NJ PNU-101387 Pharmacia schizophrenia Phase II Peapack, NJ Risperdal® IM Depot Janssen Pharmaceutica schizophrenia Phase III risperidone Titusville, NJ SL 91.1076 Sanofi-Synthelabo schizophrenia Phase I s-amisulpride New York, NY SL 91.1077 Sanofi-Synthelabo schizophrenia Phase III amisulpride New York, NY SR 31742 Sanofi-Synthelabo schizophrenia Phase II central signalling New York, NY SR 46349 Sanofi-Synthelabo schizophrenia Phase II 5HT2 antagonist New York, NY SR 48692 Sanofi-Synthelabo schizophrenia Phase II neurotensin New York, NY antagonist SR 141716 Sanofi-Synthelabo schizophrenia Phase II cannabinoid New York, NY (see also dementias, eating disorders, receptor substance use disorders) (CBI) antagonist 7N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 S C H I Z O P H R E N I A Product Name Company Indication Development Status SR 142801 Sanofi-Synthelabo schizophrenia Phase II NK3 receptor New York, NY (see also anxiety, depression) antagonist Zeldox® Pfizer schizophrenia application submitted New York, NY Zomaril™ Novartis Pharmaceuticals schizophrenia Phase III iloperidone East Hanover, NJ Titan Pharmaceuticals S. San Francisco, CA S E X U A L D I S O R D E R S Product Name Company Indication Development Status apomorphine TAP Pharmaceuticals male erectile dysfunction application submitted Deerfield, IL apomorphine Pentech Pharmaceuticals female sexual dysfunction Phase II SL tablet Buffalo Grove, IL paroxetine Pentech Pharmaceuticals premature ejaculation Phase III hydrochloride Buffalo Grove, IL capsule S U B S T A N C E U S E D I S O R D E R S Product Name Company Indication Development Status cocaine vaccine Cantab Pharmaceuticals cocaine dependence Phase I (therapeutic) Cambridge, UK cyclazocine National Institute on cocaine dependence Phase I Drug Abuse Bethesda, MD Depotrex™ Biotek opiate/alcohol dependence Phase II depot naltrexone Woburn, MA microcapsules desipramine National Institute on cocaine dependence Phase II Drug Abuse Bethesda, MD dextromethorphan ALGOS Pharmaceutical opiate dependence Phase I Neptune, NJ National Institute on Drug Abuse Bethesda, MD disulfiram National Institute on cocaine dependence Phase II Drug Abuse Bethesda, MD GBR 12909 National Institute on cocaine dependence Phase I Drug Abuse Bethesda, MD 8 N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 S U B S T A N C E U S E D I S O R D E R S Product Name Company Indication Development Status Inversine® Layton Biosciences smoking cessation Phase III mecamylamine Sunnyvale, CA (see also attention deficit/hyperactivity hydrochloride disorder) lofexedine Forum Products opiate dependence Phase III Southampton, NY National Institute on Drug Abuse Bethesda, MD mecamylamine National Institute on opiate dependence Phase II Drug Abuse Bethesda, MD Naltrel Drug Abuse Sciences alcohol/drug dependence Phase III Hillsborough, CA nicotine and Elan Transdermal smoking cessation Phase III mecamylamine Technologies transdermal patch Miramar, FL nicotine Watson Laboratories smoking cessation Phase I oral lozenge Corona, CA NS 2359 National Institute on cocaine dependence Phase I Drug Abuse Bethesda, MD NeuroSearch A/S Copenhagen, Denmark OTS™ Nicotine Anesta smoking cessation Phase II/III Salt Lake City, UT Selegiline STS National Institute on cocaine dependence Phase III Drug Abuse Bethesda, MD Somerset Pharmaceuticals Tampa, FL SL 25.1188 Sanofi-Synthelabo smoking cessation Phase I New York, NY (see also dementias) SL 92.0679 Sanofi-Synthelabo smoking cessation Phase II befloxatone New York, NY (see also depression) SR 141716 Sanofi-Synthelabo smoking cessation Phase II cannabinoid New York, NY (see also dementias, eating receptor disorders, schizophrenia) (CB1) antagonist Suboxone® Reckitt & Colman opiate dependence application submitted buprenorphine Pharmaceuticals HCl and Richmond, VA naloxone HCl Subutex® Reckitt & Colman opiate dependence application submitted buprenorphine Pharmaceuticals HCl Richmond, VA 9N E W M E D I C I N E S I N D E V E L O P M E N T F O R Mental Illnesses 2000 O T H E R D I S O R D E R S Product Name Company Indication Development Status GW320659 Glaxo Wellcome mood disorders Phase II noradrenaline/ Rsch. Triangle Park, NC (see also attention deficit/hyperactivity dopamine disorder) reuptake inhibitor substance P Merck psychiatric disorders Phase II antagonist Whitehouse Station, NJ (see also anxiety, depression) The content of this survey has been obtained through government and industry sources based on the latest information. Survey current as of May 19, 2000. The information may not be comprehensive. For more specific information about a particular product, contact the individual company directly. The entire series of “New Medicines in Development” is available on PhRMA’s web site. PhRMA Internet address: http://www.phrma.org Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association. Copyright © 2000 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given. S E L E C T E D F A C T S A B O U T M E N T A L I L L N E S S E S A