In addition, withdrawal effects of pregabalin are less severe than with other substances currently controlled in Schedule IV.Īnother commenter stated that, in their experience with pregabalin in clinical trials, pregabalin does not demonstrate any risk that would merit being considered a scheduled drug. The data are consistent with a substance that could be abused intermittently for reward, but not for reinforcement. Data from clinical trials suggest that some of pregabalin's positive psychic effects are limited and do not continue with time or continued drug use. Pregabalin does not substitute for benzodiazepines in benzodiazepine-dependent animals. Careful consideration of all the available data suggests that pregabalin has less abuse potential than Schedule IV substances. One commenter stated that the DEA should not minimize the similarity in effects produced by pregabalin and diazepam and should place pregabalin in Schedule IV of the CSA. ![]() The DEA received two comments in response to the Notice of Proposed Rulemaking. ![]() ![]() The proposed rule provided an opportunity for all interested persons to submit their comments, objections or requests for hearing to be received by the DEA on or before June 13, 2005. 811(b)).īased on the recommendation of the Acting Assistant Secretary for Health and an independent review of the available data by the DEA, the Deputy Administrator of the DEA, in a May 13, 2005, Federal Register Notice of Proposed Rulemaking (70 FR 25502), proposed placement of pregabalin into Schedule V of the CSA. Enclosed with the April 4, 2005, letter was a document prepared by the FDA entitled, "Basis for the Recommendation for Control of Pregabalin in Schedule V of the Controlled Substances Act (CSA)." The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. On April 4, 2005, the Acting Assistant Secretary for Health of the Department of Health and Human Services (DHHS), sent the Administrator of the DEA a letter recommending that pregabalin, and its salts, be placed into Schedule V of the CSA. Pregabalin has recently been placed on the market in some European countries for the treatment of epilepsy and neuropathic pain. LyricaTM will be marketed in the United States as a prescription drug product for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). On December 31, 2004, the Food and Drug Administration (FDA) approved pregabalin for marketing under the trade name LyricaTM. Sannerud, Ph.D., Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, telephone (202) 307- 7183. As a result of this rule, the regulatory controls and criminal sanctions of Schedule V will be applicable to the manufacture, distribution, dispensing, importation and exportation of pregabalin and products containing pregabalin.ĭATES: This rule is effective July 28, 2005.įOR FURTHER INFORMATION CONTACT: Christine A. SUMMARY: This final rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance pregabalin, including its salts, and all products containing pregabalin into Schedule V of the Controlled Substances Act (CSA). ![]() Schedules of Controlled Substances: Placement of Pregabalin Into Schedule VĪGENCY: Drug Enforcement Administration, Department of Justice. FR Doc 05-15036 From the Federal Register Online via GPO Access
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