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Executive Summary

WHO PROPOSING MORE RESTRICTIVE SCHEDULING FOR BUPRENORPHINE (Norwich Eaton's Buprenex), moving the narcotic analgesic product from Schedule V to Schedule III status under the 1971 Convention on Psychotropic Substances. Buprenorphine is currently marketed in injectable and sublingual preparations for management of pain. Although a committee of the World Health Organization rated the likelihood of abuse of buprenorphine as "moderate" and the therapeutic usefulness as "moderate to high," it nevertheless determined that the drug constitutes a public health hazard under Article 2, paragraph 4 of the Convention and recommended placing the substance under international control. "There is . . . a potential for problems of considerably greater magnitude as its reinforcing and opioid withdrawal suppressant effects become better known to those who are already abusing opioid such as heroin," a Sept. 22 Federal Register notice states. "The Committee was also of the opinion that on the basis of our current understanding of its pharmacology, the distinctions between the partial mu-agonist buprenorphine and such prototypic mu-agonists as heroin, morphine and methadone warrant the use of the 1971 Psychotropic Convention." WHO is also proposing that a second drug, pemoline, be added to Schedule IV of the Convention. Abbott markets the CNS stimulant in the U.S. under the Cylert brand. "Given the extent of the documented amounts of drugs moving in international channels beyond any reasonable medical need, public health and social problems of serious degree are assumed to be developing, and are likely to become more evident if the current levels of non-medical use persist," WHO explained. "In light of this assessment, the committee recommends scheduling of the drug in Schedule IV." Written comments on the proposals are being accepted by FDA's Dockets Management Branch until Oct. 24. The agency said it does not plan to hold a public meeting unless requested to do so. Requests for a meeting should be made before Oct. 7 and directed to Nicholas Reuter at FDA's Office of Health Affairs.

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