Navigation Links
Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)
Date:12/16/2008

FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings

PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual lozenge) has been accepted for review by the agency. Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Confirmation that the FDA has accepted the Intermezzo(R) NDA and has begun its review represents another important milestone in our efforts to gain FDA approval for Intermezzo(R), which we believe is positioned to be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Based on an anticipated standard review process, we currently expect to receive a complete response letter regarding Intermezzo(R) in the fourth quarter of 2009 and to initiate the potential U.S. commercialization and launch in the first half of 2010, if Intermezzo(R) is approved."

The Intermezzo(R) NDA follows the successful completion of two Phase 3 clinical trials. The first Intermezzo(R) Phase 3 trial was a double-blind, placebo-controlled crossover sleep laboratory study of 82 patients, which Transcept believes to be among the largest reported sleep laboratory studies of its type. Results from the study dem
'/>"/>

SOURCE Transcept Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5

Related biology technology :

1. Transcept Pharmaceuticals to Participate in Middle-of-the-Night (MOTN) Insomnia Investor Panel
2. Transcept Pharmaceuticals Appoints Key Senior Executives
3. Transcept Pharmaceuticals, Inc. to Present at the Natixis Bleichroeder Second Annual Hidden Gems Conference
4. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
5. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
8. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
9. Nabi Biopharmaceuticals to Present at Upcoming Industry Conferences
10. Anadys Pharmaceuticals Appoints Steve Worland, Ph.D. as President and Chief Executive Officer
11. Poniard Pharmaceuticals Announces Participation in Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... , May 23, 2013 Venaxis, Inc. (Nasdaq: ... focused on obtaining FDA clearance and commercializing its rapid, ... the pricing of an underwritten public offering of 10,000,000 ... purchase 3,500,000 shares of its common stock at an ... public offering price of $1.25 per share and related ...
(Date:5/23/2013)... , May 23, 2013  BioScrip, Inc. (NASDAQ: ... will present at the Jefferies 2013 Global Healthcare Conference ... Hyatt New York. Richard Smith ... Hai Tran , Chief Financial Officer, will ... Eastern Daylight Time.   About BioScrip ...
(Date:5/23/2013)... Can economic incentives such as gift ... of the public to increase their donations of blood? ... Carey Business School Assistant Professor Mario Macis says ... large body of recent research that supports their argument, ... issue of Science that the World Health Organization and ...
(Date:5/23/2013)... (PRWEB) May 23, 2013 Graphite ... self-lubricating bushings mounted in stainless steel pillow ... properties of GRAPHALLOY with the application and installation ... Steel Pillow Blocks work exceptionally well when ... or hostile liquids such as acids, alkalies, hydrocarbons, ...
Breaking Biology Technology:Venaxis Announces Pricing of Offering of Common Stock and Warrants 2Venaxis Announces Pricing of Offering of Common Stock and Warrants 3Offering Economic Incentives to Attract Blood Donations Should Be Encouraged, Research Team writes in Science 2Offering Economic Incentives to Attract Blood Donations Should Be Encouraged, Research Team writes in Science 3Graphite Metallizing Now Offers GRAPHALLOY® Stainless Steel Pillow Blocks for Success in Submersible Applications 2Graphite Metallizing Now Offers GRAPHALLOY® Stainless Steel Pillow Blocks for Success in Submersible Applications 3
... , SAN DIEGO , June 29 ... Diego region a $4 million grant to ... biofuels industry.  The San Diego Biofuels Initiative, a collaborative effort ... Diego Center for Algae Biotechnology (SD-CAB) and the San Diego ...
... STOCKHOLM , June 29, 2010 Karolinska Development AB ... co-investment opportunities in the life science area in the Nordic,region and other ... , , ... combination will increase,the possibilities for early life science investments in world class ...
... ... Connecting TV audiences directly to experts, policymakers, and celebrities on issues that affect us all. ... any of the controversies or issues raised in our comedy and shows. Over 60 ... www.baitandswitchtv.com , , ...
Cached Biology Technology:San Diego Region Awarded $4 Million Workforce Development Grant to Support Expanding Biofuels Industry 2San Diego Region Awarded $4 Million Workforce Development Grant to Support Expanding Biofuels Industry 3San Diego Region Awarded $4 Million Workforce Development Grant to Support Expanding Biofuels Industry 4Karolinska Development and Kurma Biofund to Enter Strategic Partnership 2Karolinska Development and Kurma Biofund to Enter Strategic Partnership 3Bait and Switch TV's Free Live Debates Invite TV Viewers to Debate with Experts in Real Time about Controversial Topics 2Bait and Switch TV's Free Live Debates Invite TV Viewers to Debate with Experts in Real Time about Controversial Topics 3Bait and Switch TV's Free Live Debates Invite TV Viewers to Debate with Experts in Real Time about Controversial Topics 4Bait and Switch TV's Free Live Debates Invite TV Viewers to Debate with Experts in Real Time about Controversial Topics 5Bait and Switch TV's Free Live Debates Invite TV Viewers to Debate with Experts in Real Time about Controversial Topics 6
(Date:5/23/2013)... , Automated conserved noncoding sequence (CNS) discovery ... grasses , Within the genome of each species, ... little change in position and sequence over millions of ... of these evolutionarily stable sequences, so-called conserved noncoding sequences ... genes or the condensation of chromosomes, but the function ...
(Date:5/23/2013)... to be the world,s most popular fruit, can be ... with purple GM varieties. , "Working with GM ... the addition of a specific compound, allows us to ... Professor Cathie Martin from the John Innes Centre. , ... better flavour, health and shelf life characteristics because even ...
(Date:5/23/2013)... Pacific Northwest National Laboratory honored more than 165 ... intellectual property at PNNL,s annual Intellectual Property Commercialization ... Department of Energy national laboratory named materials scientist ... work developing battery materials that can store large ... grid, and reduce the time it takes to ...
Breaking Biology News(10 mins):Frontiers news briefs: May 23 2Frontiers news briefs: May 23 3The world's favorite fruit only better-tasting and longer-lasting 2PNNL staff recognized for scientific accomplishments, moving technologies into the marketplace 2
... the Ecological Society of America,s (ESA) 95th Annual Meeting which ... which has the theme "Global Warming: The legacy of our ... of more than 3,000 scientists, policy makers and concerned citizens ... to discuss the ways in which climate change permeates many ...
... soda have less healthy diets through adolescence than their peers who ... The ten-year study showed that girls who drank soda at ... standards for the duration of the study, which ended at age ... not meet certain nutritional requirements, but their diets were healthier. ...
... Rupp, Ph.D., research psychologist in the Behavioral Biology Branch ... at Walter Reed Army Institute of Research, has won ... Society. Dr. Rupp is an employee of The Henry ... Inc. Rupp and her colleagues are investigating soldier ...
Cached Biology News:Ecological Society of America explores global warming at its 95th Annual Meeting 2Ecological Society of America explores global warming at its 95th Annual Meeting 3Early consumption of soda indicator of unhealthy diet 2Early consumption of soda indicator of unhealthy diet 3HJF research psychologist receives Sleep Research Society's Young Investigator Award 2
... described by end-users to be "a delight ... of light microscopy and electronic imaging. With ... does not require much space and can ... environment. The DM-BA300 combines Motic's own revolutionary ...
lid holder -see Blotters (Semi-Dry) for more info...
When added to either StemSep CD4+ or CD8+ T Cell Enrichment cocktails, human CD69 TAC is designed to deplete human CD69 from samples to isolate resting CD4+ or CD8+ T cells....
... Aquarius 384 is a compact and ... head is a unique flow-through device, ... the included wash system. Optional ... stacker system. Will be upgradable ...
Biology Products: