Transcept Pharma (TSPT) reported that FDA issued a Complete response letter to their resubmission of Intermezzo, a drug indicated for use in treating night time awakening insomnia. The original NDA was submitted in 2008 and not favorably considered by the FDA because of concerns they had about driver impairment. The company reported they did a driver impairment study and resubmitted the NDA. The most recent PDUFA Date was July 14, 2011.
Transcept has reported that the second CRL still has questions about driver impairment. This doesn’t look good for Intermezzo. Either the second driver impairment study was inadequate in design (unlikely if the FDA had input and the company followed the FDA input), or it showed driver impairment. Either case, it looks like another redo of the study.