Phase 3 sleep-lab study demonstrated that low dose sublingual
Intermezzo(R), used at the time of a middle of the night awakening,
significantly shortened time to return to sleep vs. placebo
PT. RICHMOND, Calif., Oct. 22 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that a Phase 3 study evaluating the safety and efficacy of its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge), has been published in the September 2008 issue of SLEEP, a publication of the Associated Professional Sleep Societies. 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.
On September 30, 2008, Transcept submitted a New Drug Application for Intermezzo(R) to the U.S. Food and Drug Administration. On August 29, 2008, Transcept and Novacea, Inc. (Nasdaq: NOVC) entered into a definitive merger agreement under which, if completed, Novacea will merge with Transcept. Assuming a close near the end of 2008, the combined company is expected to have an estimated cash balance of $88 to $92 million.
Thomas Roth, Ph.D., Director of Research, Chief of Sleep Medicine for
the Henry Ford Hospital Sleep Disorders and Research Center, was the
principal author and investigator for the randomized, double-blind,
placebo-controlled, 3-way cross-over study of the safety and efficacy of
Intermezzo(R) at doses of 1.75 mg and 3.5 mg compared to placebo. The study
evaluated 82 adults at five sleep laboratories with a diagnosis of DSM-IV
|SOURCE Transcept Pharmaceuticals, Inc.|
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