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Transcept gains on resubmission of middle-of-the-night insomnia drug

 
• By Donna Young

Shares of Transcept Pharmaceuticals gained as much as 11.4% on 28 September, or 76 cents, on the news that the company followed through with its pledge earlier this month to resubmit its new drug application for Intermezzo (zolpidem tartrate sublingual tablet) after failing twice before to gain the US FDA's blessing to market the medication as a treatment for middle-of-the-night insomnia (scripintelligence, 15 September 2011).

Shares of Transcept Pharmaceuticals gained as much as 11.4% on 28 September, or 76 cents, on the news that the company followed through with its pledge earlier this month to resubmit its new drug application for Intermezzo (zolpidem tartrate sublingual tablet) after failing twice before to gain the US FDA's blessing to market the medication as a treatment for middle-of-the-night insomnia (scripintelligence, 15 September 2011).

The company's most recent rejection came in a July complete response letter (CRL), in which the FDA expressed concern about whether the drug would be used safely (scripintelligence, 13...

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