Navigation Links
Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo(R) Complete Response Letter
Date:11/23/2009

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: www.transcept.com.

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.


Contact:

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

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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
(Date:6/23/2016)... -- Research and Markets has announced the ... (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, ... Global Forecast to 2021" report to their offering. ... pharmaceutical excipients market is projected to reach USD 8.1 ... the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... offering. The current unmet ... for MedImmune to enter. The US ageing population creates a ... considerable growth for effective anti-influenza medications. The introduction of a ... development is still in its infancy. Key ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media ... Pro X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice ... X users can now reveal the media of their split screens with growing ...
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is ... emergency ambulance transport experience for the millions of people who require these medical ... the taxi industry through the use of technology. Now, SmartEMS has put forth ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
Breaking Medicine News(10 mins):