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FDA clears Transcept's Intermezzo as first insomnia drug for middle-of-the-night waking.

M2 PHARMA-November 24, 2011-FDA clears Transcept's Intermezzo as first insomnia drug for middle-of-the-night waking(C)2011 M2 COMMUNICATIONS

24 November 2011 - US Transcept Pharmaceuticals Inc (NASDAQ:TSPT) said on Wednesday the US Food and Drug Administration (FDA) had approved Intermezzo (zolpidem tartrate sublingual tablet) C-IV for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Intermezzo, a lower dose formulation of zolpidem, is the first drug approved by FDA for this condition. Transcept has accepted FDA's post-marketing conditions, including a study of patient compliance with Intermezzo dosing instructions and pediatric use assessment in accordance with the Pediatric Research Equity Act (PREA).

Transcept and Purdue Pharma LP, a pain management products specialist, will jointly develop and distribute Intermezzo in US, and Purdue has to notify Transcept by 8 December 2011 whether it will proceed with the commercialisation.

Intermezzo was studied in two clinical trials with over 370 patients tested. The most commonly reported adverse reactions were headache, nausea and fatigue. Intermezzo should not be taken if alcohol has been consumed or another sleep pill taken and is recommended only when a person has at least four hours of bedtime remaining.

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Publication:M2 Pharma
Date:Nov 24, 2011
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