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:2/8/2016)... 2016 Vestagen Technical Textiles, Inc., a medical ... healthcare and other demanding applications, today announced it has ... replaces Dale Pfost , PhD, who was serving ... also joining Vestagen,s Board of Directors. ® ... barrier technologies that combines fluid repellent, antimicrobial and breathability ...
(Date:2/8/2016)... Ill. , Feb. 8, 2016  Astellas Pharma Inc. ... announced the promotion of James Robinson as president, ... company,s operations in North and South America ... Astellas Pharma US, representing the commercial organization in ... in 2013. Masao Yoshida , who is ...
(Date:2/8/2016)... , Feb. 8, 2016  CTI BioPharma Corp. ... Company received written communication from the U.S. Food and ... FDA has placed a partial clinical hold on the ... Drug ("IND") application for pacritinib. This clinical hold impacts ... the IND and will also affect planned clinical trials. ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... 08, 2016 , ... According to research by the National ... technicians to be certified or obtain continuing education. To increase patient awareness of ... Your Mouth?” campaign to inform dentists and patients about the possible lack of ...
(Date:2/7/2016)... ... February 07, 2016 , ... HealthSmart Holdings, Inc. announced today ... the tools and information to lower the costs, and increase the impact of ... providing employee healthcare benefits by as much as 22%:, + Price and ...
(Date:2/6/2016)... ... ... US Sports Camps is proud to sponsor the Bay Area Disc Association's ... leaders, ultimate organizations, and coaches from around the US. The theme for this year’s ... of Youth and Education, describes this year YUCC as “an important conversation we must ...
(Date:2/6/2016)... ... February 06, 2016 , ... ... eating disorder treatment helps to reduce the frequency and level of relapse. ... Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical tasks of the ...
(Date:2/5/2016)... ... 2016 , ... VeloReality President and co-founder Gary ... VR Indoor Trainer with multi-rider capability to an enthusiastic audience at the company's ... the weight of the unit, they also enhance the rider's experience with a ...
Breaking Medicine News(10 mins):