Eisai Petitions For Drug Listing

Eisai has asked the U.S. Court of Appeals for the District of Columbia Circuit to direct the Drug Enforcement Administration to put the company’s epilepsy drug, Fycompa, on the DEA list of controlled substances. FDA approved the drug in October 2012 and requested DEA scheduling, or classification, in January 2013. FDA says Fycompa presents a risk of serious, even life-threatening, neuropsychiatric events. Eisai is unable to sell the drug until DEA lists it and sets manufacturing, distribution, and dispensing limits. According to Eisai, in recent years the scheduling process has averaged 237 days compared with 49 days about a decade earlier.