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From the Food and Drug Administration
November 1, 2000

Clarification on Buprenorphine

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Copyright 2000 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2000American Medical Association

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JAMA. 2000;284(17):2178. doi:10.1001/jama.284.17.2178

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.

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