Transcept Pharmaceuticals Inc. (TSPT) said that the U.S. FDA has set July 14, 2011 as the PDUFA action date for its Intermezzo.
Intermezzo is indicated for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
The company's application for Intermezzo was already rejected by the FDA in October, 2010, requesting additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability.
Earlier this month, the company resubmitted its application, which is now classified by the FDA as a complete Class 2 response, and assigned a PDUFA action date of July 14, 2011.
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