INTER AMERICAN DRUG ABUSE CONTROL COMMISSION C I C A D

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1 INTER AMERICAN DRUG ABUSE CONTROL COMMISSION C I C A D Secretariat for Multidimensional Security FORTY SIXTH REGULAR SESSION November 18 20, 2009 Miami, Florida OEA/Ser.L/XIV.2.46 CICAD/doc.1760/09 11 November 2009 Original: Spanish PROGRESS IN DEVELOPING MEDICATIONS AND VACCINES FOR DRUG ADDICTION TREATMENT DR. IVAN MONTOYA

2 Progress in Developing Medications and Vaccines for Drug Addiction Treatment Iván D. Montoya, M.D., M.P.H. Acting Deputy Director, Division of Pharmacotherapies and Medical Consequences of Drug Abuse NIDA

3 Addiction Chronic disease Compulsive behavior of drug use Brain changes Genetic/environmental risk factors Medical, psychological and social consequences Prevetable Treatable Frequently with relapses

4 DA D2 Receptor Availability Dopamine D2 Receptors are Lower in Addiction DA DA Cocaine DA DA DA DA DA DA DA DA DA DA Reward Circuits Non-Drug Abuser Alcohol DA DA DA DA DA DA Heroin Control Addicted Reward Circuits Drug Abuser

5 Illicit Drug Addiction Millions of People NSDUH, 2006

6 Rationale for Medications and Vaccine Research Public health problems Limited efficacy of psychotherapies New knowledge about the effects of illicit drugs and pathophysiology of addictions New pharmacological targets New biomarkers Pharmacogenetics New molecules, medications and vaccines

7 The NIDA Medications Development Program Congressional Mandate to NIDA March, 1990 Establish a national program on biological and pharmacological approaches to heroin and cocaine addiction treatment. Develop a close working relationship with the pharmaceutical industry. Conduct studies to gain approval of new medications for addiction treatment. Work with FDA to assure that efficacy of compounds is expeditiously evaluated and approved.

8 The NIDA Medications Development Program Partnership Industry-Academia-Govt. Screening Preclinical Profiling & Lead Optimization Preclinical Safety Phase 1 Safety Phase 2 Activity Dose Phase 3 Efficacy NDA Approval FDA

9 Pharmacotherapy Approaches P P Abuse Dependence / Addiction USE P P P SIDs Intoxication Withdrawal Delirum Psychosis Anxiety Mood Sleep Sexual P Medical Psychological Social Sequelae

10 The NIDA Medications Development Program Four NDA approvals: Levo-Alpha Acetyl Methadol (LAAM) Buprenorphine Buprenorphine/naloxone Naltrexone In late-stage development: Lofexidine Nicotine vaccine

11 Opioid Addiction Methadone Buprenorphine Naltrexone LAAM Clonidine Lofexidine

12 Methadone or Buprenorphine Compared to heroin users who are not in treatment, patients in treatment show: death rates criminal activity / incarceration employment needle sharing HIV infection rates Advantage of buprenorphine: Safer in overdose situations (due to partial agonist activity)

13 Total number of patients receiving a prescription for Subutex or Suboxone from U.S. outpatient retail pharmacies, Years SDI Total Patient Tracker, Extracted 3/09 Patients 500, , , , , , , , ,000 50,000 SUBOXONE SUBUTEX Years File: TPT SAMHSA Subutex Suboxone.xls

14 Cocaine

15 Cocaine Medications Evaluated Phase I Phase II Screen Phase II Phase III Carnitine/CoQ Amantadine Selegiline TS Cocaine Vaccine Baclofen Disulfiram Cyclazocine Donepezil Bupropion Tolcapone Gabapentin Cabergoline Modafinil Gingko Desipramine Metyrapone Hypericum celebrex Dextroamphetamine Lamotrigine Levodopa/Carbidopa Olanzapine Ondansetron Paroxetine Pentoxifylline Piracetam Pramipexole Riluzole Sertraline Tiagabine Valproate Disulfiram Enadoline Hydergine Mazindol Methylphenidate Naltrexone Pemoline Pergolide Phenytoin Propranolol Reserpine Risperidone Selegiline IR Valproate Modafinil Baclofen Naltrexone Desipramine Buprenorphine Vaccine

16

17 Vigabatrin for Cocaine Addiction Abstinence During Last 3 Weeks of Tx Failures Placebo 49 (92.5%) Successes 4 (7.5%) 3.7 x Vigabatrin 36 (72%) 14 (28%) P = (Chi-square test)

18 Methamphetamine

19 Bupropion for Methamphetamine Addiction Abstinence During Last 3 Weeks of Tx Failures Placebo 68 (94.4%) Successes 4 (5.56%) 3.2 x Bupropion 65 (82.3%) 14 (17.7%) P = 0.02 (Chi-square test)

20 Immunotherapies Vaccines Antibodies

21 Immunotherapy Development Program Preclinical Studies anti-pcp mab anti-methamphetamine mab anti-mdma mab anti-cocaine mab Clinical Studies Anti-Nicotine vaccine Anti-Cocaine vaccine

22 Capillary Blood Flow Antibodies Mechanism of Action Brain (Owens & Gentry 2002)

23 Rationale for Immunotherapy against Addictions Drug Use Drug in blood ADDICTION X Blood/Brain Barrier Reward Dopamine Release Receptors in Brain

24 24 Nicotine Addiction

25 Nicotine Vaccine

26 Breaking the Addiction Cycle 26

27 Proportion of Subjects Quit Each Week: Point Prevalence Stratified by Antibody Levels TQD TQD All NicVAX Subjects: ITT N=18/61 p= % Quit per Week N=12/ placebo low Ab high Ab* N=17/ Study Week *Top 30% by AUC

28

29 Cocaine Vaccine

30 Potential Clinical Applications MAbs Overdoses Prevent brain toxicity Vaccines Aid to quit use Relapse prevention Prevention of brain toxicity Prevention of development of addiction

31 Summary Medications approved by the FDA for opioid (heroin) addiction (methadone, buprenorphine, naltrexone) Medications under research for cocaine, methamphetamine, and cannabis addiction Immunotherapy (vaccines or antibodies) is a promising approach Nicotine and cocaine vaccines phase III clinical trials in progress

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