Transcept Pharmaceuticals Inc. (TSPT) said that the U.S. FDA has expressed continued concerns about the safety profile of insomnia drug Intermezzo based on information in the company's resubmitted NDA.
In a teleconference with the FDA held earlier today, the company expects to receive a complete response letter from the FDA for Intermezzo on or before July 14, 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo NDA review.
Transcept seeks approval to market Intermezzo for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
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