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Transcept Pharmaceuticals Announces Preliminary Results From the Intermezzo® Highway Driving Study
Date:10/18/2010

company submitted a NDA for Intermezzo® to the FDA in September 2008.  In October 2009, the FDA issued a Complete Response Letter in which it indicated that Transcept had submitted substantial evidence of effectiveness for the use of Intermezzo® in its intended indication and that the data submitted did not indicate significant next-day residual effects at four hours.  However, given the unique Intermezzo® indication, the FDA requested additional data on next-day effects, with particular reference to driving ability, and a demonstration that inadvertent patient dosing errors could be adequately minimized.  Transcept plans to resubmit the NDA for Intermezzo® in the first quarter of 2011, and anticipates a six-month review by the FDA.

Conference Call ScheduledTranscept will host a conference call and live webcast to discuss the preliminary analysis of data from the Intermezzo® highway driving study on Tuesday, October 19, 2010, at 8:00 a.m. EDT. Telephone numbers for the live conference call are 877-638-4558 (U.S.) and 914-495-8537 (International). The webcast can be accessed on the Investors page of the Transcept website at www.transcept.com and will be available for replay until close of business on November 23, 2010.

A telephone replay of the conference call will be available shortly after the conclusion of the call until end of business on October 23, 2010. The replay telephone numbers are 800-642-1687 (U.S.) and 706-645-9291 (International), replay passcode: 19398284.

About TransceptTranscept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), for which a New Dr
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SOURCE Transcept Pharmaceuticals, Inc.
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