Navigation Links
Transcept Pharmaceuticals Announces Preliminary Results From the Intermezzo® Highway Driving Study
Date:10/18/2010

the October 2009 Complete Response Letter."

Thomas Roth, Ph.D., Director, Sleep Disorders and Research Center, Henry Ford Hospital, said, "This study represents a robust approach to characterizing the effect of a sleep aid candidate on next morning driving ability, and serves as a model for the future testing of medication driving safety.  Findings from the highway driving study provide good evidence to support the view that Intermezzo® shows no significantly increased risk of driving impairment when taken with at least four hours remaining in bed.  Intermezzo® has the potential to be an important treatment for those insomnia patients whose only current option to treat a middle of the night awakening is to take a 7 to 8 hour sleep aid at bedtime in anticipation of an awakening that may not occur."

Transcept plans to resubmit the Intermezzo® NDA in the first quarter of 2011, and anticipates a six-month review by the FDA.  In the revised NDA, Transcept plans to address FDA concerns raised in an October 2009 Complete Response Letter by submitting the results of the highway driving study, a revised unit dose package, new patient tools to reinforce the importance of proper dosing, and new epidemiology findings that quantify the current off-label use of 7 to 8 hour hypnotics in the middle of the night.

Transcept estimates that cash, cash equivalents and marketable securities at September 30, 2010 were approximately $74 million, and believes these resources will be sufficient to allow for the resubmission of the Intermezzo® NDA and to complete the planned placebo-controlled study of ultra low dose ondansetron as an adjunctive treatment of obsessive compulsive disorder.

About the Intermezzo® Development Program Transcept completed pre-clinical and clinical studies of Intermezzo®, including two Phase 3 clinical trials, in 2008.  The
'/>"/>

SOURCE Transcept Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Related medicine technology :

1. Transcept Pharmaceuticals to Host Conference Call to Discuss Preliminary Analysis of Intermezzo® Highway Driving Study
2. Transcept Pharmaceuticals to Present at Newsmakers in the Biotech Industry Conference
3. Transcept Pharmaceuticals to Present at BIO Investor Forum
4. Transcept Pharmaceuticals to Present at UBS Global Life Sciences Conference
5. Transcept Pharmaceuticals to Present at Rodman & Renshaw and Stifel Nicolaus Investor Conferences in September 2010
6. Transcept Pharmaceuticals Receives Notice of Allowance for Second U.S. Patent Application Covering Intermezzo(R)
7. Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo(R) Complete Response Letter
8. Transcept Pharmaceuticals Reports Third Quarter 2009 Financial Results
9. Transcept Pharmaceuticals to Present at Lazard Capital Markets Healthcare Conference on November 17
10. Transcept Pharmaceuticals to Report Third Quarter 2009 Results and Host Conference Call on November 12
11. Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/26/2015)... MOUNTAIN VIEW, Calif. , Feb. 26, 2015  IRIDEX ... will release its fourth quarter and full year 2014 financial ... 2015.   In conjunction with the release, the Company will ... 5:00 p.m. Eastern Time on Thursday, March 5, ... other business developments. Interested parties may access the ...
(Date:2/26/2015)... 2015 Legislation passed today by the House ... help prevent inappropriate prescriptions in Medicare Part D from ... of Medicare Act (PIMA) of 2014 , introduced by ... (R-TX) and Ranking Member Jim McDermott (D-WA), recognizes ... and implement the right policies, said the Pharmaceutical Care ...
(Date:2/26/2015)... --Research and Markets ( http://www.researchandmarkets.com/research/2vn6hh/radiation_therapy ) has ... - Global Strategic Business Report" report to their ... markets for Radiation Therapy Equipment in US$ Million by ... and Radiation Therapy Simulator. The report provides separate comprehensive ... Japan , Europe ...
Breaking Medicine Technology:IRIDEX Announces Fourth Quarter and Full Year 2014 Conference Call and Release Date 2PCMA Statement on the 'Protecting the Integrity of Medicare Act' 2Radiation Therapy Equipment - Global Strategic Business Report 2015-2020: Linear Accelerator, Treatment Planning Systems, and Radiation Therapy Simulator 2
... Neurobiological Technologies, Inc. (Nasdaq: NTII ) ("NTI") announced ... dividend of $0.18 per share of common stock, which will ... as of November 30, 2009. The December 9, 2009 extraordinary ... to a plan of complete liquidation and dissolution and an ...
... , , WAYNE, Pa., Nov. 20 ... its fiscal first quarter ended September 30, 2009. ... decreased approximately $234,000, or 2.7%, to $8,435,000 during the three-month ... period last fiscal year. The Company reported the decreased ...
Cached Medicine Technology:Neurobiological Technologies Announces Extraordinary Dividend of $0.18 per Share 2Escalon(R) Reports First Quarter Fiscal 2010 Results 2Escalon(R) Reports First Quarter Fiscal 2010 Results 3Escalon(R) Reports First Quarter Fiscal 2010 Results 4Escalon(R) Reports First Quarter Fiscal 2010 Results 5Escalon(R) Reports First Quarter Fiscal 2010 Results 6Escalon(R) Reports First Quarter Fiscal 2010 Results 7
(Date:2/27/2015)... If there is one thing that drives ... head lice outbreak at their child’s school. While head lice ... is nothing short of a nightmare for many parents as ... children, or within their child’s classroom. Just when they think ... scratching again. , Local lice removal company, Lice Troopers ...
(Date:2/27/2015)... Philanthropy is a continuous force restoring people’s ... help to restore that faith by helping the people in ... husband/wife Realtor team gives to the local children in need ... while others have been added as the need arose. , ... haven and counseling for women who have suffered physical and ...
(Date:2/27/2015)... NewYork (PRWEB) February 27, 2015 The ... and trends in the global celiac disease market. It ... outlook, research and development activities, and investments. , Celiac ... of gluten damages the small intestine. Celiac disease often ... in every 100 people is affected by celiac disease ...
(Date:2/27/2015)... WI (PRWEB) February 27, 2015 UAS ... Adult Cubes, at Natural Products Expo West, March 6 ... are very excited to release the hands down best ... cream taste with an extra zing of Vitamin C. ... Cubes, winner of the NutrAward 2014, Delicious Living’s Supplement ...
(Date:2/27/2015)... (PRWEB) February 27, 2015 The Willliams ... Plant in Lincoln County, Wyoming. The plant processes ... preparation for interstate natural gas pipeline transport. It also ... The Opal plant initially began operations in 1958, and ... growing natural gas production in Wyoming. The plant ...
Breaking Medicine News(10 mins):Health News:Anxiety over head lice among Miami parents as surge in head lice cases reported by local lice removal company Lice Troopers 2Health News:Mr. And Mrs. Smits Proves That Altruism Works All Year Round 2Health News:Global Celiac Disease Market Counts on Drug Launch for Growth 2Health News:Global Celiac Disease Market Counts on Drug Launch for Growth 3Health News:UAS LifeSciences to Launch UP4 Adult Cubes at Expo West 2Health News:Clean Water Systems Supplies Advanced Chlorine Disinfection Skid for Wyoming Gas Plant 2
... sickening erotica fantasies, two US teenagers in the Florida state ... woman, forcing her 12-year-old son to join the outrage , ... ,Authorities allege Avion Lawson, 14, and Nathan Walker, ... who forced their way into the woman's apartment in a ...
... of The Women's and Children's Hospital, Adelaide in Australia has ... the staff there are exposed to every day. ... of problems with ageing facilities in two of the hospital's ... risk". ,It states: "WCH is experiencing immediate facilities, ...
... Nora Ali, daughter of Bangladeshi immigrants to the United States, ... 17, won the final competition, held in Alabama Saturday, by ... said Wednesday, quoting website wcco.com. ,"I just want ... company with my elder sister who does stem cell research. ...
... developing the world's first vaccine against dengue fever as Singapore ... Friday. ,Clinical tests on up to 3,000 people ... Stephenne, GlaxoSmithKline Biologicals president. ,"We've been working on ... more or less," The Straits Times quoted Stephenne as saying. ...
... researchers say that a single drug for keeping both ... diabetes under check may soon be available. ... Medicine and Pharmacology at Tulane University School of Medicine, ... Sulfonylurea-based therapy has been found to significantly reduce glucose ...
... 36 percent since last year, local press reported Sunday, as ... ,The outbreak has killed 17 people in Thailand ... year, the English-language Nation newspaper reported, quoting figures from the ... by the virus, which is especially dangerous in children and ...
Cached Medicine News:Health News:US Teens Charged With Gang Raping a Woman 2Health News:US Teens Charged With Gang Raping a Woman 3Health News:Concerns Raised Over Risks for Patients and Staff in Australian Hospital 2