FDAnews Drug Daily Bulletin

DEA Places Eisai’s Fycompa into Schedule III

Dec. 4, 2013

The Drug Enforcement Administration has placed Eisai’s seizure medication Fycompa into schedule III of the Controlled Substances Act, clearing the final regulatory hurdle on the drug’s pathway to market.

The FDA approved Fycompa (perampanel) for certain patients with epilepsy aged 12 years and older Oct. 22, 2012. The drug has central nervous system depressant and hallucinogenic properties, which prompted HHS to recommend to the DEA Fycompa be placed in Schedule III.

Schedule III controlled substances are deemed to have a potential for abuse, with abuse leading to moderate or low physical dependence or high psychological dependence. Any person who handles a Schedule III drug must be registered with the DEA to do so, including manufacturers, distributors, pharmacies, importers, exporters and researchers.

The scheduling determination becomes effective Jan. 2, 2014 and allows Eisai to begin marketing Fycompa the same day.

The drugmaker has petitioned the FDA to push back the drug’s Oct. 22, 2012 new chemical entity (NCE) exclusivity start date to coincide with its market launch. The drug cannot legally be marketed until the DEA’s scheduling determination becomes effective, meaning Eisai has lost more than a year of its five-year NCE exclusivity period, the drugmaker says. — Melissa Winn

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