Transcept Pharmaceuticals Inc awarded FDA approval of Intermezzo C-IV for middle-of-the-night insomnia.
M2 EQUITYBITES-November 24, 2011-Transcept Pharmaceuticals Inc awarded FDA approval of Intermezzo C-IV for middle-of-the-night insomnia(C)2011 M2 COMMUNICATIONS http://www.m2.com
Pharmaceutical company Transcept Pharmaceuticals Inc (Nasdaq:TSPT) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for Intermezzo C-IV for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
The company stated the recommended dose of Intermezzo (zolpidem tartrate sublingual tablet) for non-elderly patients is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed. The 1.75 mg dose is recommended for patients over the age of 65.
Additionally, the company stated the recommended doses of other FDA approved zolpidem products range between 5 mg and 12.5 mg and are indicated for bedtime use.
According to the company, the safety and efficacy of Intermezzo were evaluated in two placebo-controlled studies for the treatment of patients with insomnia characterised by difficulty returning to sleep after awakening in the middle of the night.
In conjunction, the company has agreed to FDA post-marketing commitments, including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment, in accordance with the Pediatric Research Equity Act (PREA).
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|Date:||Nov 24, 2011|
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