1. 1 Medication Development for Treatment of Drug Dependence Donald R. Wesson, MD Consultant, CNS Medications Development Chairman, ASAM Medications Development Committee

2. 2 Medication for Treatment of Drug Dependence Relapse Prevention Relapse Prevention Abstinence Facilitation Abstinence Facilitation Detoxification Detoxification

3. 3 Medication for Treatment of Drug Dependence Relapse Prevention Medications to assist a patient who has stopped using to remain abstinent from a drug of abuse (e.g., disulfiram)

4. 4 Medication for Treatment of Drug Dependence Abstinence Facilitation Medication to assist a patient who is continuing to use to stop using. (e.g., methadone or buprenorphine)

5. 5 Function of Medication in Drug Abuse Treatment Detoxification Medications to alleviate drug withdrawal signs and symptoms (e.g., benzodiazepines for alcohol withdrawal)

6. 6 Terms to Avoid Replacement Replacement Substitution Substitution

7. 7 Main Tracks for New Drug Development 1. Basic or Academic Research 2. Pharmaceutical Company Sponsored Research

8. 8 1. Basic and Academic Research University or Research Institutes University or Research Institutes Funded by NIAAA, NIDA, or private foundations Funded by NIAAA, NIDA, or private foundations Primary Products: Primary Products: Trained Researchers Trained Researchers Maximum number of publications per research study Maximum number of publications per research study Advancement of Science/Treatment Advancement of Science/Treatment More research funding More research funding

9. 9 2. Pharmaceutical Company Drug Development Identification of new compounds Identification of new compounds Animal behavioral screening and Toxicity Animal behavioral screening and Toxicity Phase I-IV clinical trials Phase I-IV clinical trials Getting FDA approval of a New Drug Application Getting FDA approval of a New Drug Application Marketing the compound Marketing the compound Primary Products: Primary Products: New medication with marketing exclusivity New medication with marketing exclusivity Sales Sales Increased stock value Increased stock value

10. 10 Average Cost of a New Medication 1980’s $ 231 Million

11. 11 Average Cost of a New Medication 1990’s $ 804 Million

12. 12 Medications Currently Marketed for Treatment of Addiction in the US Antabuse Antabuse Naltrexone Naltrexone Methadone Methadone LAAM (soon to be no more) LAAM (soon to be no more) Buprenorphine Buprenorphine

13. 13 Conclusions Drug Dependence is being increasingly accepted as a brain Disease Drug Dependence is being increasingly accepted as a brain Disease Better understanding of the neurobiology of drug dependence provides unprecedented opportunities for developing better pharmacotherapy of drug dependence Better understanding of the neurobiology of drug dependence provides unprecedented opportunities for developing better pharmacotherapy of drug dependence

14. 14 Conclusions With the possible exception of alcohol, pharmaceutical companies have no economic incentive to develop new medications exclusively to treat drug dependence. With the possible exception of alcohol, pharmaceutical companies have no economic incentive to develop new medications exclusively to treat drug dependence.

15. 15 Conclusion A pharmaceutical company is necessary for commercial manufacturing and distribution of medications for treatment of drug dependence. A pharmaceutical company is necessary for commercial manufacturing and distribution of medications for treatment of drug dependence.

16. 16 Final Conclusion In light of increasing costs of medication development, better mechanisms than now exist must be developed to enable partnerships between the NIDA/NIAAA and pharmaceutical companies. In light of increasing costs of medication development, better mechanisms than now exist must be developed to enable partnerships between the NIDA/NIAAA and pharmaceutical companies.

17. DiMasi, J.A.; Hansen, R.W. & Grabowski, H.G. 2003. The price of innovation: new estimates of drug development costs. J Health Econ 22(2):151-85.