Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Qu...( - Company Reports Positive Top-line...),Health

- Company Reports Positive Top-line Results from Second Phase 3 Study of

Intermezzo(R) -

PT. RICHMOND, Calif., June 4 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that it has completed all pivotal and supporting clinical trials that will be included in the new drug application (NDA) for its lead product candidate, Intermezzo(R). Following its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on April 2, 2008, Transcept now expects to submit the Intermezzo(R) NDA in the third quarter of 2008.

Transcept's meeting with the FDA was triggered by the Company's successful completion of a second Phase 3 clinical trial of Intermezzo(R) (3.5 mg zolpidem tartrate sublingual lozenge), a low dose buffered sublingual formulation designed to treat insomnia in patients who awaken in the middle-of-the-night (MOTN) and have difficulty returning to sleep. The randomized, double-blind, placebo-controlled outpatient study involving 294 patients met its primary endpoint of significantly reducing time to sleep onset vs. placebo.

In addition to the Phase 3 outpatient study, Transcept has also completed a Phase 3 double-blind, placebo-controlled crossover sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the sleep-lab study demonstrated that Intermezzo(R) 3.5 mg significantly shortened time to sleep onset in comparison to placebo in patients experiencing middle-of-the-night awakenings. Compared to placebo, patients on the 3.5 mg dose also reported statistically significant improvements in total sleep time, sleep efficiency, subjective number of awakenings post-dose, sleep quality, refreshing sleep, and next day ability to function. Overall, Intermezzo(R) was well tolerated in both Phase 3 studies, and exhibited a safety profile similar to placebo.

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