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LILLY's CESAMET (NABILONE) LAUNCH AWAITS DEA SCHEDULING

Executive Summary

LILLY's CESAMET (NABILONE) LAUNCH AWAITS DEA SCHEDULING of the synthetic cannabinoid, Lilly said. Cesamet, which is chemically related to THC, was approved by FDA on Dec. 27 "for use in the treatment of nausea and vomiting associated with cancer chemotherapy." Lilly said the drug "is indicated for those patients who have failed to respond adequately to conventional anti-emetic treatment." A course of therapy "runs one to five days concomitantly with chemotherapy," Lilly said. Once scheduled by the Drug Enforcement Agency and introduced, Cesamet will compete with Unimed's Marinol (dronabinol or THC) which is approved for the same indication. Marinol, approved June 6, still has not come to market because of delays in DEA scheduling. Unimed President Paul Bollenbacher recently denied rumors that the DEA decided not to reclassify the marijuana-derived product from Schedule I to II. He explained that despite a six month delay, DEA "reassured" the firm of the agency's intent to reschedule the product to the less restrictive Shedule II ("The Pink Sheet" Dec. 16, "In Brief"). In April 1983, FDA's Drug Abuse Advisory Cmte. recommended that Cesamet be placed in Schedule III under the Controlled Substances Act. Despite FDA's position at that time that nabilone and THC are "essentially identical in abuse potential," the cmte. recommended Schedule III for Cesamet after having recommended Schedule II for THC. Cesamet is currently marketed as an anti-emetic in Canada and the U.K. Those approvals were granted in 1982 and 1983, respectively. Lilly noted that it will not determine the price of Cesamet until the product clears DEA.

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