Navigation Links
Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
Date:6/4/2008

- Company Reports Positive Top-line Results from Second Phase 3 Study of

Intermezzo(R) -

PT. RICHMOND, Calif., June 4 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that it has completed all pivotal and supporting clinical trials that will be included in the new drug application (NDA) for its lead product candidate, Intermezzo(R). Following its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on April 2, 2008, Transcept now expects to submit the Intermezzo(R) NDA in the third quarter of 2008.

Transcept's meeting with the FDA was triggered by the Company's successful completion of a second Phase 3 clinical trial of Intermezzo(R) (3.5 mg zolpidem tartrate sublingual lozenge), a low dose buffered sublingual formulation designed to treat insomnia in patients who awaken in the middle-of-the-night (MOTN) and have difficulty returning to sleep. The randomized, double-blind, placebo-controlled outpatient study involving 294 patients met its primary endpoint of significantly reducing time to sleep onset vs. placebo.

In addition to the Phase 3 outpatient study, Transcept has also completed a Phase 3 double-blind, placebo-controlled crossover sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the sleep-lab study demonstrated that Intermezzo(R) 3.5 mg significantly shortened time to sleep onset in comparison to placebo in patients experiencing middle-of-the-night awakenings. Compared to placebo, patients on the 3.5 mg dose also reported statistically significant improvements in total sleep time, sleep efficiency, subjective number of awakenings post-dose, sleep quality, refreshing sleep, and next day ability to function. Overall, Intermezzo(R) was well tolerated in both Phase 3 studies, and exhibited a safety profile similar to placebo.

Glenn
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
4. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
5. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
6. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
7. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
8. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
9. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
10. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
11. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... According to the new ... therapy, Hydrotherapy), Accessories (Posture Mirror, Exercise Ball), Applications (Pediatric, ... Global Forecast to 2019" published by MarketsandMarkets, the global ... Million by 2019 from $14,240.0 Million in 2014, ... 2019. Browse 74 market data tables ...
(Date:9/19/2014)... Research and Markets has announced the ... Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023" ... this report, the human microbiome market is segmented by application, ... is expected to be valued as $294 million in 2019 ... within the forecast period of 2019-2023. The market is driven ...
(Date:9/19/2014)... Mich. , Sept. 19, 2014  Diplomat, the ... of David Dreyer to the Board of ... independent director and will also serve as chair of ... almost 30 years of accounting, financial, compliance and operating ... Mr. Dreyer has served as chief financial officer, chief ...
Breaking Medicine Technology:Physiotherapy Equipment Market Worth $19,786.3 Million by 2019 2Physiotherapy Equipment Market Worth $19,786.3 Million by 2019 3Physiotherapy Equipment Market Worth $19,786.3 Million by 2019 4Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 2Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 3David Dreyer Appointed to Diplomat Board of Directors 2
(Date:9/21/2014)... 21, 2014 Hundreds of Risperdal ... in Pennsylvania’s Philadelphia Court of Common Pleas, Bernstein ... proceeding’s next monthly meeting has been scheduled for ... , “Our Firm is representing a number of ... litigation. We are pleased with its continued progress,” ...
(Date:9/21/2014)... 2014 (HealthDay News) -- Young women starting college understand ... foods they should eat. But they aren,t confident they ... to a new study. The study involved ... Illinois,s Peer Education Exercising and Eating Right program. The ... choose to eat if they were very busy with ...
(Date:9/21/2014)... 2014 Discount-Dress.com, a company ... recently announced its decision to implement a new shopping ... for ladies across the world. Furthermore, the company has ... ladies. , The new items come in fashionable ... prices, up to 56 percent off. "We are happy ...
(Date:9/21/2014)... Dallas, TX (PRWEB) September 21, 2014 ... and Chinese Fenofibrate (CAS 49562-28-9) Industry, 2009-2019 ... on Global and Chinese Fenofibrate (CAS 49562-28-9) ... information of Fenofibrate (CAS 49562-28-9) including its ... explores global and China’s top manufacturers of ...
(Date:9/21/2014)... (PRWEB) September 21, 2014 High in ... teams of disabled and able-bodied athletes rafted the Colorado ... a ropes course in pursuit of outdoor adventure. At ... national non-profit World T.E.A.M. Sports, disabilities proved to be ... successfully completed the three stage event. , Each participating ...
Breaking Medicine News(10 mins):Health News:Risperdal Lawsuits Move Forward in Pennsylvania Litigation, As Court Schedules October Meeting, Bernstein Liebhard LLP Reports 2Health News:Risperdal Lawsuits Move Forward in Pennsylvania Litigation, As Court Schedules October Meeting, Bernstein Liebhard LLP Reports 3Health News:Risperdal Lawsuits Move Forward in Pennsylvania Litigation, As Court Schedules October Meeting, Bernstein Liebhard LLP Reports 4Health News: College Women Can Use Food Strategies, Study Finds 2Health News:Discount-Dress.com Implements A New Shopping Cart Software And Provides New Beach Wedding Dresses 2Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 2Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 3Health News:Fenofibrate Industry Global and Chinese Analysis for 2014-2019 Now Available at LifeScienceIndustryResearch.com 4Health News:Disabled Athletes Excel at World T.E.A.M. Sports’ Adventure Team Challenge 2Health News:Disabled Athletes Excel at World T.E.A.M. Sports’ Adventure Team Challenge 3
... LLC has joined the effort to help relieve ... of Cyclone Nargis. Special donation kiosks,have been developed ... the,virtual world of Second Life, with coordination being ... island,( http://slurl.com/secondlife/Simuality/106/83/41 )., In addition, links to ...
... Coalition for Iraq and Afghanistan Veterans Gather in Virginia ... Organizations, CHANTILLY, Va., May 9 As the ... death toll climbs above 4,000 and,casualty numbers approach the ... organizations on the homefront have organized to help,bereaved families ...
... disease-resistant gene wards off fusarium wilt on leaves , , ... to helping tomatoes fight a fungus that causes wilt ... there,s an ongoing battle against the ability of plant ... system, according to background information in the study. One ...
... demands reap mental benefits regardless of age or ... News) -- Having an intellectually demanding job that ... abilities during retirement, regardless of intelligence, education level ... suggests. , "Our society is expected to live ...
... wanted minimally invasive procedure more often, despite drawbacks , , ... be trumping science when it comes to treatments for ... patients are getting a newer, minimally invasive surgery, because ... though there is little data on actual differences in ...
... From Bush Administration,s $770 Million Cut to,Medicare-Financed Nursing Home ... the,American Health Care Association (AHCA) and Alliance for Quality ... release and comment on a,new study from The Lewin ... from the Bush Administration,s recently-announced cut of,$770 million to ...
Cached Medicine News:Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 2Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 3Health News:Leading Veterans Service Organizations Meet Near Washington May 13-15, 2008 4Health News:Demanding Jobs May Pay Cognitive Dividends in Retirement 2Health News:Newer Prostate Cancer Treatment Similar to Traditional Surgery 2Health News:Newer Prostate Cancer Treatment Similar to Traditional Surgery 3
... easy on delicate urethral tissues. ... hydrophilic coating provide nearly friction-free ... It's easy to maintain sterility. ... with its own sterile water, ...
The latex-free, PVC-free Antibacterial Hydro Personal catheter combines two remarkable innovations into one exclusive catheter that delivers an antibacterial agent while providing the virtually frict...
... Rochester Medical's line ... the intermittent catheters you ... All four product configurations ... and antibacterial hydro - ...
... easy on delicate urethral tissues. ... hydrophilic coating provide nearly friction-free ... It's easy to maintain sterility. ... with its own sterile water, ...
Medicine Products: