The US Food and Drug Administration (FDA) notified Transcept Pharmaceuticals Inc that it has classified the recent Intermezzo New Drug Application (NDA) resubmission as a complete Class 1 response and assigned a Prescription Drug User Fee Act (PDUFA) action date of November 27, 2011, for the completion of the NDA review. Company shares rose as much as 34% on the news, as investors saw the shorter review period of 2 months for Intermezzo, Transcept’s experimental sleep drug, as a positive sign.
Transcept is developing Intermezzo (zolpidem tartrate sublingual tablet) as a prescription sleep aid for use as needed when a middle of the night awakening is followed by difficulty returning to sleep.
