POINT RICHMOND, Calif., Jan. 18, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
Transcept expects that the Intermezzo® NDA resubmission, if accepted and deemed complete by the FDA, will be subject to a Class 2 six-month review.
The Intermezzo® resubmission package is intended to address issues raised in the October 2009 FDA Complete Response Letter. New information contained in the resubmission package includes data and analyses from the recently completed Intermezzo® highway driving study, a comparative review of data from previous driving studies of sleep aids and other medications, and redesigned product packaging and instructional tools. The resubmission also includes a recent epidemiology study that demonstrates the widespread use of 7 to 8 hour hypnotic drugs in the middle of the night, despite the fact that these products have been approved only for bedtime dosing.
"If approved, we anticipate that Intermezzo® will be the first prescription sleep aid for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep," said Glenn A. Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals. "We plan to work closely with the FDA through the resubmission process and are fully committed to making this important therapeutic option available to insomnia patients."
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) in January 2011 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Transcept and Purdue Pharmaceutical Products L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. Transcept is also developing SetrodonTM, an ultra low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with SSRIs. Transcept plans to begin a Phase 2 study of SetrodonTM in early 2011. For further information, please visit the Transcept website at: www.transcept.com.