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
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.