Transcept Pharmaceuticals Announces Intermezzo® PDUFA Action Date Of November 27, 2011

Transcept Pharmaceuticals Announces Intermezzo® PDUFA Action Date Of November 27, 2011

POINT RICHMOND, Calif., Oct. 4, 2011 /PRNewswire/ - Transcept Pharmaceuticals, Inc. (TSPT) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has classified the recent Intermezzo® New Drug Application (NDA) resubmission as a complete Class 1 response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 27, 2011 for the completion of the NDA review.

About Transcept

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. Transcept is developing Intermezzo® (zolpidem tartrate sublingual tablet) as a prescription sleep aid for use as needed when a middle of the night awakening is followed by 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 TO-2061, a low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with approved first-line pharmacotherapy. For further information, please visit the Transcept website at: www.transcept.com.

Suggested Articles

German researchers uncovered 28 antibodies that neutralize COVID-19 and are working with Boehringer Ingelheim to advance them into clinical testing.

Oragenics is ending a phase 2 study of its oral mucositis drug, yanking its IND application and switching its focus to a COVID-19 vaccine.

The vehicle, which Blackstone claims is the largest life sciences private fund, has committed close to $1 billion to companies including Alnylam.