FDA to review re-submitted Intermezzo in November 2011 for Insomnia

Transcept Pharma had resubmitted its drug application for its middle-of-the-night insomnia drug Intermezzo (zolpidem tartrate sublingual tablet) in January 2011. The drug had failed to win approval in October 2009. The FDA sent out a Complete Response Letter regarding the resubmitted New Drug Application. In it, the FDA stated that it cannot conclude that Intermezzo can be used safely based on the information in the NDA. The proposed label for Intermezzo indicates that the drug should only be taken when patients have at least four hours of bedtime remaining before being active again. The FDA suggests further investigations of whether body weight and demographic factors contribute to differentially elevated blood levels the morning after dosing Intermezzo, develop strategies to decrease next-morning zolpidem levels, and, after mitigation strategies are implemented, demonstrate that next-morning blood levels do not present an unacceptable risk of next-day impairment, which may include the conduct of an additional driving study. Transcept Pharma has again resubmitted an NDA for Intermezzo with the results of a positive driving study and following a meeting the FDA has accepted the NDA and classified it as a Class 1 response, setting a decision date of 27 November 2011