Transcept Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has informed the company that it should expect to receive formal notice of a three month extension of the review period for the new drug application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet). The Intermezzo NDA had been assigned a Prescription Drug User Fee Act (PDUFA) date of July 30, 2009. Under this revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.

In the normal course of the Intermezzo NDA review, the FDA previously requested additional information regarding middle of the night dosing instructions. As both the request and the Transcept response occurred late in the review cycle, the FDA has informed the company that it will extend the NDA review cycle by three months to consider the new information.

Glenn A. Oclassen, President and Chief Executive Officer, commented, "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(R) NDA will be necessary. We felt it our responsibility to inform shareholders in advance of a formal FDA notification and will update our shareholders as appropriate after such notice is received."

Oclassen added, "We appreciate the willingness of the FDA to take the time necessary to fully consider our recent amendment to the Intermezzo(R) NDA. We remain confident in the strength of our regulatory submissions and look forward to working with the FDA as it completes its review. Our goal remains to provide a new and important therapeutic for those patients who suffer from middle of the night awakenings with difficulty returning to sleep."

Intermezzo Phase 3 clinical trials have been completed and, on September 30, 2008, Transcept submitted an NDA to the FDA, which was accepted for filing and assigned a PDUFA date of July 30, 2009.

Transcept Pharma is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience.