Transcript Pharmacology of Buprenorphine

Medication Development
for Treatment of Drug
Dependence
Donald R. Wesson, MD
Consultant, CNS Medications Development
Chairman, ASAM Medications Development Committee
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Medication for Treatment of
Drug Dependence
Relapse Prevention
 Abstinence Facilitation
 Detoxification

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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)
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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)
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Function of Medication in Drug Abuse
Treatment
Detoxification
Medications to alleviate drug
withdrawal signs and symptoms
(e.g., benzodiazepines for alcohol
withdrawal)
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Terms to Avoid

Replacement

Substitution
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Main Tracks for New Drug
Development
1.
Basic or Academic Research
2.
Pharmaceutical Company
Sponsored Research
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1. Basic and Academic Research

University or Research Institutes

Funded by NIAAA, NIDA, or private foundations

Primary Products:

Trained Researchers

Maximum number of publications per research study

Advancement of Science/Treatment

More research funding
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2. Pharmaceutical Company Drug Development
Identification of new compounds
Animal behavioral screening and Toxicity
Phase I-IV clinical trials
Getting FDA approval of a New Drug Application
Marketing the compound
Primary Products:



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
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New medication with marketing exclusivity
Sales
Increased stock value
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Average Cost of a New Medication
1980’s
$ 231
Million
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Average Cost of a New Medication
1990’s
$ 804
Million
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Medications Currently Marketed for
Treatment of Addiction in the US
Antabuse
 Naltrexone
 Methadone
 LAAM (soon to be no more)
 Buprenorphine

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Conclusions

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
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Conclusions

With the possible exception of alcohol,
pharmaceutical companies have no
economic incentive to develop new
medications exclusively to treat drug
dependence.
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Conclusion

A pharmaceutical company is necessary
for commercial manufacturing and
distribution of medications for treatment
of drug dependence.
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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.
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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.