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Back To Vidyya The FDA Issues A Clarification On Buprenorphine

Buprenorphine, A Partial Opioid Agonist, Is Not Currently Approved Or Legally Available In The US

The FDA, Center for Substance Abuse Treatment, and Drug Enforcement Administration (DEA) have jointly informed physicians that buprenorphine, a partial opioid agonist, is not currently approved or legally available in the United States for the treatment of opiate addiction, except when used as an investigational new drug.

The agencies clarified the drug's status in response to anecdotal reports that Buprenex (Reckitt & Colman Pharmaceuticals Inc, Richmond, Va), which contains buprenorphine, is being used off-label to treat opiate addiction. Although Buprenex has been approved by the FDA for relief of moderate to severe pain, buprenorphine is a controlled narcotic, and its use for the treatment of opiate addiction must comply with the Narcotic Addict Treatment Act of 1974.

Under this act, practitioners who wish to dispense narcotic drugs for maintenance treatment or detoxification of persons with narcotic addiction must meet conditions including annual registration with the DEA. Only physicians participating in clinical trials of buprenorphine in the treatment of opiate addiction can conduct the research without registration with the DEA.

For further information, call Robert Lubran, Acting Director, Office of Pharmacological and Alternative Therapies, Center for Substance Abuse Treatment, at (301) 443-0744.


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Editor: Susan K. Boyer, RN
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