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:8/30/2014)... 2014  Boston Scientific has released the primary ... Heart Failure (NECTAR-HF) clinical trial, the first and ... stimulation (VNS) for the treatment of heart failure ... and Cardiology and Director of the Clinical Investigation ... et de la Recherche Medicale presented the results ...
(Date:8/30/2014)... --  Royal Philips  (NYSE: PHG, AEX: PHIA) today announced ... system designed to enable global hospitals and health systems ... cost pressures. Making its debut at the  European Society ... this week, Affiniti provides innovative technology to ... deliver high quality patient care. "Affiniti ...
(Date:8/29/2014)... , Aug. 29, 2014 /PRNewswire-iReach/ -- Market ... Scanner Industry, 2009-2019 is a professional and in-depth ... Crystallography Scanner industry . The report firstly reviews ... its classification, application and manufacturing technology. The report ... X-Ray Crystallography Scanner listing their product specification, capacity, ...
Breaking Medicine Technology:Boston Scientific Announces Primary Endpoint Results of NECTAR-HF Clinical Trial 2Boston Scientific Announces Primary Endpoint Results of NECTAR-HF Clinical Trial 3Boston Scientific Announces Primary Endpoint Results of NECTAR-HF Clinical Trial 4Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 2Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 3Philips Debuts New Affiniti Ultrasound System at the European Society of Cardiology Congress 2014 4X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 2X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 3X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 4X-Ray Crystallography Scanner Industry For Global and Chinese Market Forecast to 2019 5
... Barbara,Ann Karmanos Cancer Institute's Philip A. Philip, M.D., ... outcome,of one of the largest randomized phase III ... an education session about the,future of pancreatic cancer ... annual meeting in Chicago, IL. , The clinical ...
... - Data from first Phase 3 trial presented at ... 3 trial open the door for,patient recruitment in Europe ... 2007 --,Theratechnologies (TSX: TH) reported today that 26-week data ... were presented today in Toronto at ENDO, the 89th,annual ...
Cached Medicine Technology:Clinical Trial Results Change Standard of Care for Pancreatic,Cancer Patients, Future Therapies Discussed 2Clinical Trial Results Change Standard of Care for Pancreatic,Cancer Patients, Future Therapies Discussed 3Theratechnologies: TH9507 Phase 3 Clinical Update 2Theratechnologies: TH9507 Phase 3 Clinical Update 3
(Date:8/30/2014)... Denver, Colorado (PRWEB) August 30, 2014 Daily ... Cure for Yeast Infection is a method created by Sarah ... means. , The author of this new program actually ... created for any sufferer to be able to access it, ... had an important determination in finding an effective cure for ...
(Date:8/30/2014)... 30, 2014 The Plastic Surgery Group ... Jersey and even in the U.S. to provide clients ... off of patients’ waists with deep-tissue heating. , Unlike ... sections, Vanquish is more inclusive to target large sections ... comfortably under panels about one inch away from their ...
(Date:8/30/2014)... Albany, New York (PRWEB) August 30, 2014 ... a combination of Nutrition and Pharameuticals. Nutraceuticals is ... by extracting healthy ingredients from natural food sources. ... specific health benefits to the human body. Nutraceutical ... multivitamins, diet supplements, fortified foods and more. Although ...
(Date:8/30/2014)... Delhi, India (PRWEB) August 30, 2014 ... introduced low cost SEO service for small businesses. , ... or start-ups cannot afford costly search engine optimization service. ... budget of small businesses into account. , On ... said, “We have introduced this low cost SEO service ...
(Date:8/30/2014)... August 30, 2014 Ticket Down ... Open Tennis Championship tickets in NYC. This ... code US-OPEN-2014 for all day session, evening session, courtside ... sales for this prestigious Grand Slam Tournament. , The ... 8/30/14 , US Open Tennis Championship: Men's/Women's 3rd Round ...
Breaking Medicine News(10 mins):Health News:Natural Cure for Yeast Infection Review Exposes New Natural Treatment 2Health News:NJ Top Docs Presents, The Plastic Surgery Group 2Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 2Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 3Health News:A Granular Analysis of the Nutraceutical Ingredients Market by Transparency Market Research 4Health News:RBSEO Services Introduces Low Cost SEO Service for Small Businesses 2Health News:US Open Tennis Tickets: Ticket Down Slashes Ticket Prices for Labor Day Weekend Sessions and More 2Health News:US Open Tennis Tickets: Ticket Down Slashes Ticket Prices for Labor Day Weekend Sessions and More 3Health News:US Open Tennis Tickets: Ticket Down Slashes Ticket Prices for Labor Day Weekend Sessions and More 4Health News:US Open Tennis Tickets: Ticket Down Slashes Ticket Prices for Labor Day Weekend Sessions and More 5
... ... Hand Wash Monitoring System that ensures compliance by all covered personnel with ... is non invasive and quite frankly, as simple as washing your hands. ... is issued an RFID embedded name badge or tag. This tag ...
... Inspire Hope and Debunk Myths in Response to Latino AIDS ... Inc. and the Kaiser Family Foundation today unveiled the second ... , the groundbreaking Spanish-language media campaign featuring the personal stories ... their loved ones. The new campaign materials will debut ...
... Corporation , the market leader in Enterprise Inventory Optimization ... Jerry Saltzman, senior director, supply chain operations, Wyeth ... SAP® World Tour 2009 event in New York ... inventory optimization plays a crucial role in the modern supply ...
... for those with easy access to nature , THURSDAY, Oct. 15 ... you,re likely to be. , For instance, people who live within ... and depression, Dutch researchers report. , The findings put concrete ... be true. , "It,s nice to see that it shows ...
... give back to the communities in the cities visited ... Radiation Oncology (ASTRO) is partnering with Gilda,s Club Chicago ... Chicago will work with ASTRO by participating in the ... for November 1-5, 2009, at McCormick Place West in ...
... LOS ANGELES, Oct. 15 The National Association of ... its newest member to the Board of Directors. ... proposition of specialty health organizations. Wellspring Autism Network is ... Board of Directors. , (Logo: http://www.newscom.com/cgi-bin/prnh/20090505/LA10604LOGO ) , ...
Cached Medicine News:Health News:Patented Hand Wash Monitoring System Provides Full Accountability 2Health News:Patented Hand Wash Monitoring System Provides Full Accountability 3Health News:Univision and Kaiser Foundation Mark National Latino AIDS Awareness Day With New Campaign Featuring People Living With HIV/AIDS 2Health News:Univision and Kaiser Foundation Mark National Latino AIDS Awareness Day With New Campaign Featuring People Living With HIV/AIDS 3Health News:Univision and Kaiser Foundation Mark National Latino AIDS Awareness Day With New Campaign Featuring People Living With HIV/AIDS 4Health News:Univision and Kaiser Foundation Mark National Latino AIDS Awareness Day With New Campaign Featuring People Living With HIV/AIDS 5Health News:SmartOps and Wyeth Consumer to Present at SAP(R) World Tour 2009 2Health News:Green Spaces Boost the Body and the Mind 2Health News:Green Spaces Boost the Body and the Mind 3Health News:Wellspring Autism Network Added to NASHO's Board of Directors 2
Inquire...
... serum tube is specially coated with microscopic ... process. Serum / gel tubes contain a ... tube; during centrifugation, this gel forms a ... blood cells. In the primary tube and ...
BD Vacutainer® Plus Plastic Serum Tubes have spray-coated silica and are used for serum determinations in chemistry, serology, and immunohematology....
The inner wall of the tube is coated with spray-dried lithium, ammonium or sodium heparin. These additives are anti-coagulants, which activate anti-thrombins, thus blocking the coagulation cascade of...
Medicine Products: