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:1/18/2017)... , Jan. 18, 2017 The Philadelphia Pediatric Medical ... developing medical devices for children. The Consortium chose ... seed grants of $50,000 each. The devices under ... nerve signals, a hand-operated rapid blood delivery system for emergency ... babies. ...
(Date:1/18/2017)... India , January 18, 2017 According to a ... and by Application: Global Opportunity Analysis and Industry Forecast, 2014 - 2022," the ... to reach $1,127 million by 2022, growing at a CAGR of 8.26% from ... in terms of revenue. Continue Reading ... ...
(Date:1/18/2017)...  With an annual growth ranging from 6% to 10%, South East ... International Expo, March 22-24, 2017) serves the industry by fostering the regional discourse - ... Investment Forum ASEAN -- India ... conference content Enhanced business matchmaking program Roadshows ... ...
Breaking Medicine Technology:
(Date:1/18/2017)... ... January 18, 2017 , ... At Hallmark Nameplate, their commitment ... they have achieved certification to ISO 13485. This certification is another way they are ... date products and services that they need. , The ISO 13485 Certification is a ...
(Date:1/18/2017)... ... January 18, 2017 , ... Rollerblade®, the worldwide ... (ABT), an innovative braking system that allows skaters of all levels to stop ... the biggest concerns of beginner and intermediate skaters – learning how to brake ...
(Date:1/17/2017)... NY (PRWEB) , ... January 17, 2017 , ... Gym ... opening of a new showroom at South Dixie Hwy in Miami, FL. , “We ... at Gym Source. “The new innovative in-store concept is designed to give clients a ...
(Date:1/17/2017)... , ... January 17, 2017 , ... SunView Software’s Service ... for Innovation of the Year. , Each year, Pink Elephant recognizes a ... innovative approach to address a specific business problem or opportunity. The award highlights original ...
(Date:1/17/2017)... (PRWEB) , ... January 17, 2017 , ... Mirror Mirror ... earned the highest honor of Diamond Level in Zeltiq’s Crystal Rewards Program. Practice founder, ... part of this elite group of providers. , Produced by Zeltiq, CoolSculpting is ...
Breaking Medicine News(10 mins):