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FDA rejects Transcept's insomnia drug

The US Food and Drug Administration has told Transcept Pharmaceuticals its insomnia drug, Intermezzo, is not ready for marketing approval

The US Food and Drug Administration (FDA) has told Transcept Pharmaceuticals its insomnia drug, Intermezzo (zolpidem tartrate sublingual tablet), is still not ready for marketing approval after the company sent a second new drug application (NDA).

Prior to issuing a complete response letter (expected July 14), the agency held a teleconference with Transcept expressing continued concerns about the safety profile of the drug based on information provided by the company.

It is Transcept's intention that Intermezzo be used for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The company said: "After the complete response letter is received, Transcept will announce additional information on the content of the letter and the company's plans forthe future regulatory development of Intermezzo."

According to the Wall Street Journal, shares of Transcept were down 41 per cent at $5.11 in recent premarket trading.

13th July 2011


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