Thursday, Transcept Pharmaceuticals, Inc. (TSPT) said it received information from the U.S. Food and Drug Administration, or FDA, that it should expect to get a formal notice of a three-month extension for the new drug application review of its sleep aid drug Intermezzo.
The company had submitted a new drug application, or NDA, for Intermezzo with the FDA on September 30, 2008. If approved, the drug would be the first commercially available sleep aid to help patients return to sleep if they wake up in the middle of the night.
The company noted that the FDA had previously requested certain additional details regarding the study of the drug. The review period extension was due to the request and response being made very late into the review cycle.
Transcept expects the FDA's review of the drug to be available on or before October 31, 2009.
Glenn Oclassen, the president and chief executive officer of Transcept stated, "Although we have not yet received a formal written notification from the FDA, our conversations with them indicate that additional review time for the Intermezzo NDA will be necessary."
TSPT is currently trading down 30 cents or 5.45% at $5.20.
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