Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Int...( FDA to review Intermezzo(R) (zolpidem...)

FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings

PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual lozenge) has been accepted for review by the agency. Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Confirmation that the FDA has accepted the Intermezzo(R) NDA and has begun its review represents another important milestone in our efforts to gain FDA approval for Intermezzo(R), which we believe is positioned to be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Based on an anticipated standard review process, we currently expect to receive a complete response letter regarding Intermezzo(R) in the fourth quarter of 2009 and to initiate the potential U.S. commercialization and launch in the first half of 2010, if Intermezzo(R) is approved."

The Intermezzo(R) NDA 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. Results from the study dem
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