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Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
Date:10/1/2008

Intermezzo(R) (zolpidem tartrate sublingual lozenge) developed to be the

first sleep aid specifically for use in the middle of the night when

patients awaken and have difficulty returning to sleep

PT. RICHMOND, Calif., Oct. 1 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge). Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be 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 Intermezzo(R) NDA submission follows the successful completion of two Phase 3 clinical trials. The first Intermezzo(R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. This objective study demonstrated that the Intermezzo(R) 1.75 mg and 3.5 mg doses, when used at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo, and there was no evidence of next day residual sedative effects with either dose. Transcept believes that these are the lowest zolpidem doses that have been reported to be statistically superior to placebo in producing sleep. When patients used the 3.5 mg dose, the study also indicated statistically significant improvements in total sleep time, sleep efficiency, subjective number of post-dose awakenings, sleep quality, level of refreshed sleep, and next day ability to function.

The second Phase 3 clinical trial was a double-blind, placebo-controlled outpatient study in which 294 patients used either In
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SOURCE Transcept Pharmaceuticals, Inc.
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