Will third time be the charm for Transcept's sleep drug?

Transcept Pharmaceuticals ($TSPT) is expecting to hear from the FDA shortly about its third bid for approval of the sleep drug Intermezzo, which is a low-dose form of zolpidem tartrate (Ambien) used to help people fall asleep when they wake up in the middle of the night. The drug uses technology that enables a tablet to dissolve and the active ingredient to be absorbed in the mouth. Regulators have previously harped on the safety risks to patients getting behind the wheel after taking the drug, but Transcept has included dosing instructions in its latest app to limit this problem. The FDA action date for the company's application is Nov. 27, which falls on a Sunday, and the agency's decision could be made public either shortly before or after that date. Article

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