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

onstrated that the Intermezzo(R) 1.75 mg and 3.5 mg doses, when used at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo, with no evidence of next day residual sedative effects with either dose. Further, when patients used the 3.5 mg dose, the study also indicated statistically significant improvements in total sleep time, sleep efficiency, subjective number of post-dose awakenings, sleep quality, level of refreshed sleep, and next day ability to function. Transcept believes that these are the lowest zolpidem doses that have been reported to be statistically superior to placebo in producing sleep.

The second Phase 3 clinical trial was a double-blind, placebo-controlled outpatient study in which 294 patients used either Intermezzo(R) 3.5 mg or placebo at home, at the time they awakened in the middle of the night and had difficulty returning to sleep. This Phase 3 clinical trial also met its primary endpoint of significantly reducing the time required for the patient to return to sleep versus placebo. After dosing and returning to sleep, patients in the outpatient study who were randomized to Intermezzo(R) also reported fewer subsequent awakenings and less time awake during the remainder of the night. There was no evidence of next day residual sedative effects after middle of the night use of Intermezzo(R) versus placebo.

About Transcept Pharmaceuticals

Transcept Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the fields of psychiatry and sleep medicine. The lead Transcept product candidate, Intermezzo(R), is a sublingual low dose formulation of zolpidem that has been developed for use as-needed for the treatment of insomnia when a middle of the nigh
'/>"/>

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:5/25/2013)... Republic (PRWEB) May 25, 2013 Significant ... optical manipulation have been recognized with presentation of ... The presentations were made 16 April during the SPIE ... the international society for optics and photonics , is ... Perina of Palacký University was presented with the 2011 ...
(Date:5/25/2013)... Oakland, CA (PRWEB) May 25, 2013 Dennis ... Medical Center in Oakland, CA reports that recently there has ... Cesium 131 has markedly improved the permanent seed, or low ... this newer isotope has a higher energy, a shorter half ... tumor. It is true that Cesium 131 has a higher ...
(Date:5/24/2013)... May 24, 2013 Dr. Ingrid Warmuth and ... Swedesboro, NJ, are proud to announce an Open House at ... place on Saturday, June 8th from 10 AM to 2 ... Newport, MHS, PA-C and staff will be on hand to ... and aesthetic treatments, and provide complimentary cosmetic consultations. There will ...
(Date:5/24/2013)... In a sneak preview of ... present technologies with applications in multiple and diverse ... Optics and Photonics symposium in San Diego, ... international society for optics and photonics , the ... and technology meeting in North America, with approximately ...
Breaking Biology Technology:ICO Honors Three with Awards during SPIE Optics and Optoelectronics 2ICO Honors Three with Awards during SPIE Optics and Optoelectronics 3Dennis R. Hill MD HDR Prostate Brachytherapy Specialist Compares Prostate Cancer Treatment Options: Not All Low Dose Rate Brachytherapy Isotopes Are the Same 2Dennis R. Hill MD HDR Prostate Brachytherapy Specialist Compares Prostate Cancer Treatment Options: Not All Low Dose Rate Brachytherapy Isotopes Are the Same 3See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 2See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 3See What’s in Earth’s Future ? and Out in Space Now ? at SPIE Optics and Photonics 4
... 9 Boston Scientific,Corporation (NYSE: BSX ) ... has revised its Rating Outlook on the Company, ... long-term credit rating of,BB+., Fitch said the ... is making toward stabilizing its drug-eluting stent and ...
... Pressure,BioSciences, Inc. (Nasdaq: PBIO ) ("PBI") ... (PNNL), the Harvard School of,Public Health (HSPH), the ... Drug Administration (FDA) presented data generated through the,use ... last week,s,(June 1-5) American Society for Mass Spectrometry,s ...
... Inc. (Nasdaq:,NUVA), a medical device company focused on developing ... today,that Kevin O,Boyle, Executive Vice President and Chief Financial ... Annual Growth Stock,Conference at the Four Season Hotel, Chicago, ... A live Web cast of the presentation will ...
Cached Biology Technology:Boston Scientific Welcomes Revised Outlook From Fitch Ratings 2Boston Scientific Welcomes Revised Outlook From Fitch Ratings 3Four Independent Research Groups Present Data Generated by Pressure Cycling Technology (PCT) at the ASMS Conference on Mass Spectrometry and Allied Topics in Denver, CO 2Four Independent Research Groups Present Data Generated by Pressure Cycling Technology (PCT) at the ASMS Conference on Mass Spectrometry and Allied Topics in Denver, CO 3Four Independent Research Groups Present Data Generated by Pressure Cycling Technology (PCT) at the ASMS Conference on Mass Spectrometry and Allied Topics in Denver, CO 4NuVasive to Present at William Blair 28th Annual Growth Stock Conference 2NuVasive to Present at William Blair 28th Annual Growth Stock Conference 3
(Date:5/24/2013)... water scientists from around the world today issued a ... span of one or two generations, the majority of ... under the handicap of severe pressure on fresh water, ... no substitute. This handicap will be self-inflicted and is, ... to chronic underlying problems led by mismanagement and sent ...
(Date:5/23/2013)... world,s most popular fruit, can be made both better-tasting ... varieties. , "Working with GM tomatoes that are ... a specific compound, allows us to pinpoint exactly how ... from the John Innes Centre. , The research could ... and shelf life characteristics because even higher levels of ...
(Date:5/23/2013)... More than 13,000 ships per year, carrying more than 284 ... generating roughly $1.8 billion dollars in toll fees for the ... than 55 million gallons of water are used from Gatun ... 2 million people living in the isthmus. , However, ... than 20 percent of the ships at sea, has demanded ...
Breaking Biology News(10 mins):A majority on Earth face severe self-inflicted water woes within 2 generations: Scientists 2A majority on Earth face severe self-inflicted water woes within 2 generations: Scientists 3A majority on Earth face severe self-inflicted water woes within 2 generations: Scientists 4The world's favorite fruit only better-tasting and longer-lasting 2Reforestation study shows trade-offs between water, carbon and timber 2Reforestation study shows trade-offs between water, carbon and timber 3
... ARBOR, Mich.---A type of fungus that,s been lurking underground for ... DNA, has been cultured, photographed, named and assigned a place ... represents an entirely new class of fungi: the Archaeorhizomycetes ... fungus that made headlines a few months ago, this finding ...
... the southern tip of Mexico,s Baja peninsula has proven to ... according to a new study led by researchers at Scripps ... of a 10-year analysis of Cabo Pulmo National Park (CPNP), ... journal, revealed that the total amount of fish in ...
... of obstetrics and gynecology and microbiology at Boston ... new study funded by a five-year $13.3 million ... Infectious Diseases (NIAID). Anderson will investigate the vaginal ... tobacco plants (called "plantibodies") to prevent sexually transmitted ...
Cached Biology News:Hidden soil fungus, now revealed, is in a class all its own 2Hidden soil fungus, now revealed, is in a class all its own 3Hidden Baja undersea park is the world's most robust marine reserve 2Hidden Baja undersea park is the world's most robust marine reserve 3BUSM professor awarded $13.3 million to study potential treatments to prevent STDs 2
Rabbit polyclonal to Bag5 ( Abpromise for all tested applications). entrezGeneID: 9529 SwissProtID: Q9UL15...
Rabbit polyclonal to Tryptophanyl tRNA synthetase ( Abpromise for all tested applications). Antigen: Recombinant full length protein (Human): Tryptophanyl tRNA synthetase Entrez Gene ID: 745...
WTAP Antibody...
Anti-Dardarin Immunogen: Synthetic peptide from rat LRRK2. Available Date: 38814...
Biology Products: