Safety stalls Transcept's sleep drug again; firm awaits CRL.(Thursday, July 14)

Apparently, it will take more than a next-day driving study to satisfy the FDA's concerns regarding the safety of Transcept Pharmaceuticals Inc.'s insomnia drug Intermezzo, a sublingual formulation of zolpidem that the Point Richmond, Calif.-based firm is hoping to position as the first sleep aid specifically for middle-of-the-night awakening. Despite high hopes by the company ahead of the July 14 PDUFA date, Transcept said on July 12 that it expected another complete response letter (CRL) after a call with the FDA indicated continued worries about the drug's safety profile, specifically the next-day residual effects, with particular emphasis on next-day driving, said Glenn Oclassen, …