Navigation Links
Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo(R) Complete Response Letter

POINT RICHMOND, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). As previously announced, the Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

Following the receipt of official FDA minutes of the meeting, Transcept plans to provide an update on its discussions with the FDA and the status of the anticipated Intermezzo® NDA resubmission.

About Transcept Pharmaceuticals, Inc.

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo® (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 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. In October 2009 Transcept received a Complete Response Letter from the FDA on the Intermezzo® NDA in which the FDA stated that it could not approve the NDA in its present form. Transcept is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. For further information, please visit the company's website at:

Forward Looking Statements

This press release contains forward looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). Transcept disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the safe harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, plans to provide an update on discussions between Transcept and the FDA and plans to re-submit the Intermezzo® NDA. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, whether Transcept is able to obtain from its meeting with FDA and the official minutes of the meeting information that would be sufficient to provide investors with reliable information on which to base an investment decision in Transcept and whether Transcept believes it can sufficiently satisfy, through a re-submission of the Intermezzo® NDA, concerns expressed by FDA in its October 28, 2009 Complete Response Letter.


Transcept Pharmaceuticals, Inc.
Greg Mann
Director of Corporate Communications
(510) 215-3567

SOURCE Transcept Pharmaceuticals, Inc.

Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results
2. Transcept Pharmaceuticals to Present at Lazard Capital Markets Healthcare Conference on November 17
3. Transcept Pharmaceuticals to Report Third Quarter 2009 Results and Host Conference Call on November 12
4. Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
5. Transcept Pharmaceuticals to Report First Quarter 2009 Results
6. Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
7. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
8. Sagent Pharmaceuticals to Present at Piper Jaffray Health Care Conference
9. Oceanside Pharmaceuticals Announces Launch of Librax(R) AG
10. Alexza Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
11. AUDIO from Medialink and Ortho-McNeil-Janssen Pharmaceuticals Inc.: Getting Ready for Cold and Flu Season
Post Your Comments:
(Date:11/25/2015)... 25, 2015 AAIPharma Services Corp./Cambridge Major ... at least $15.8  Million to expand its laboratories ... . The expansion will provide additional office ... growing demands of the pharmaceutical and biotechnology markets. ... will provide up to 40,000 square feet of ...
(Date:11/25/2015)...  ARKRAY USA , Inc., a ... demonstrating the accuracy of its blood glucose meter systems. ... Diabetes and Cardiovascular Disease in Los Angeles ... ® 01 meter and the Assure ® ... to accurately measure glucose levels in blood is essential ...
(Date:11/25/2015)... , November 25, 2015 Kitov ... ) (TASE: KTOV), a biopharmaceutical company focused on the ... various clinical conditions, today announced the closing of its ... Shares ( ADSs ), each representing 20 ordinary shares ... 3,158,900 ADSs. The ADSs and warrants were issued in ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... 2015 , ... On November 10, 2015, Bohrer Brady, LLC filed a class ... of a home health care worker who provided companionship services for the elderly, ill ... employed by Humana, Inc., Humana at Home, Inc., and SeniorBridge Family Companies (CT), Inc. ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... people across the country to celebrate their sobriety and show through pictures what ... “before and after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... physicians and athletic programs, launches new Wimbledon Athletics Facebook page to ... young athletes for unsuspected cardiac abnormalities. About 2,000 people under the age of ...
(Date:11/25/2015)... ... November 25, 2015 , ... Smiles by Stevens ... Bruxism, and moderate facial wrinkling. While many patients are aware of the benefits of ... success Botox® delivers to those suffering with discomfort, soreness, and pain as a result ...
(Date:11/25/2015)... IL (PRWEB) , ... November 25, 2015 , ... ... to six decades of music, friendships, and learning in its 65th Anniversary Brillianteen ... held Dec. 5-6. , For 65 years, Brillianteen has been a ...
Breaking Medicine News(10 mins):