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Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
Date:10/28/2009

scept will need to conduct one or more additional safety studies. Transcept will request a meeting with the FDA to discuss specific requirements for approval.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Transcept is committed to making this important new potential therapy available to insomnia patients. We will continue to work closely with the FDA to address their questions and define the path forward for Intermezzo®."

Conference Call Scheduled

Transcept will host a conference call and live webcast to discuss the Complete Response Letter on Thursday, October 29, 2009, at 8:30 a.m. EDT. Telephone numbers for the live conference call are 866-206-7202 (U.S.) or 703-639-1112 (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 12, 2009. A playback of the call will be available through November 12, 2009 through a telephone replay number that can be obtained through Transcept at 510-215-3500.

About Intermezzo®

Intermezzo® (zolpidem tartrate sublingual tablet), the lead product candidate at Transcept, has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo® is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo® uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption.

Two Phase 3 clinical studies evaluated 376 patients receiving either
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SOURCE Transcept Pharmaceuticals, Inc.
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