Navigation Links
Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
Date:10/1/2008

Intermezzo(R) (zolpidem tartrate sublingual lozenge) developed to be the

first sleep aid specifically for use in the middle of the night when

patients awaken and have difficulty returning to sleep

PT. RICHMOND, Calif., Oct. 1 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge). Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The Intermezzo(R) NDA submission 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. This objective study demonstrated 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, and there was no evidence of next day residual sedative effects with either dose. Transcept believes that these are the lowest zolpidem doses that have been reported to be statistically superior to placebo in producing sleep. 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.

The second Phase 3 clinical trial was a double-blind, placebo-controlled outpatient study in which 294 patients used either In
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
2. Critical Pharmaceuticals Enter Sustained Release hGH Arena
3. Anadys Pharmaceuticals to Present at the JMP Securities Healthcare Focus Conference
4. Potentia Pharmaceuticals Announces Positive Safety Data and Study Expansion in Phase I Trial for Lead Drug Candidate POT-4
5. Quark Pharmaceuticals Announces First RNAi Drug Candidate Having a Novel, Proprietary Structure Covered by Quark Intellectual Property
6. Lotus Pharmaceuticals, Inc.s New Drug Laevo-Bambutero Begins Evaluation for Clinical Trials
7. VIA Pharmaceuticals Completes Patient Visits in Phase 2 Acute Coronary Syndrome (ACS) Trial
8. QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
9. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
10. Oramed Pharmaceuticals Commences Phase 2A Trials of its Oral Insulin Capsule on Type 1 Diabetics
11. Vion Pharmaceuticals Enters into Agreement to Conduct a Phase I/II Clinical Trial of Cloretazine(R) in Combination with Induction Therapy in Poor Prognosis AML Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/1/2015)...  AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX ), a specialty ... innovative therapies for the treatment of acute and breakthrough ... chief financial officer  will be participating in three upcoming ... Mizuho Third Annual Healthcare Corporate Access Day ... New York Bank ...
(Date:4/30/2015)... April 30, 2015 /PRNewswire/ - Pivotal Therapeutics Inc. ... with a focus on Omega-3 therapies for cardiovascular ... highlights and financial results for the fiscal year ... herein are in Canadian dollars unless otherwise stated. ... significant, with the right strategic partners and additional ...
(Date:4/30/2015)... April 30, 2015  Accuray Incorporated (Nasdaq: ... an agreement with MIM Software Inc. to further ... and CyberKnife ® product portfolios. The new ... technology. This is Accuray,s second collaboration with MIM; ... the first iPad-based treatment plan review capability, PlanTouch™. ...
Breaking Medicine Technology:AcelRx Pharmaceuticals to Participate at Upcoming Investor Conferences in May 2Pivotal Therapeutics Announces 2014 Financial Results 2Pivotal Therapeutics Announces 2014 Financial Results 3Pivotal Therapeutics Announces 2014 Financial Results 4Pivotal Therapeutics Announces 2014 Financial Results 5Pivotal Therapeutics Announces 2014 Financial Results 6Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 3
... COLD SPRING HARBOR, N.Y. , May 18 AccuVein ... Medipath Division of Morepen Laboratories to sell the AV300 vein finder in ... signed 30 distributors worldwide. , , ... AccuVein AV300 helps healthcare professionals locate veins for blood draw , ...
... , WINTER PARK, Fla. , May 18 ... cataract surgery and presbyopia, today announced that the company has received ... System for anterior capsulotomy during cataract surgery.   , ... The LensAR Laser System integrates ...
Cached Medicine Technology:AccuVein Signs Exclusive Distribution Agreement in India to Sell Vein Illumination Device 2AccuVein Signs Exclusive Distribution Agreement in India to Sell Vein Illumination Device 3LensAR Laser System(TM) Receives FDA Clearance for Use in Cataract Surgery 2
(Date:5/1/2015)... Providenciales, Turks and Caicos Islands, BWI (PRWEB) May 02, ... has a new website! It is http://www.thevenetiangracebay.com ... resort itself, and it incorporates the stunning white and ... "According to a study of Google, sixty seven percent ... process. The study showed that smartphones were used ...
(Date:5/1/2015)... 2015 Jusuru International has been awarded ... repositioning of its flagship nutritional supplement, Liquid BioCell™ Life, ... new name, new logo, new packaging, new products, and ... designed to identify and promote programs that serve as ... “DSA congratulates Jusuru International for their outstanding accomplishments and ...
(Date:5/1/2015)... 2015 The Workgroup for Electronic ... on the use of health IT to create efficiencies ... resource to the United States Government Accountability Office (GAO) ... cards in Medicare. The report, “ Potential Uses of ... released to the public on Apr. 24, 2015 and ...
(Date:5/1/2015)... 01, 2015 It’s raining bills on Capitol ... proposals to expand federal support for telemedicine. , ... has been working with Congress,” said Jonathan Linkous, CEO of ... the nation is poised to embrace the use of telecommunications ... step in fulfilling ATA’s mission to improve quality, access, equity ...
(Date:5/1/2015)... KY (PRWEB) May 01, 2015 Ernst ... CEO, Dr. Joshua Rosenthal, Co-Founder & CSO, and Burak ... finalists for the EY Entrepreneur Of The Year® ... Ernst & Young is a global leader in ... to be one of the top audit companies ...
Breaking Medicine News(10 mins):Health News:Turks and Caicos Resort, The Venetian on Grace Bay, Launches New Web Presence 2Health News:Jusuru International Receives 2015 DSA Ethos Award 2Health News:Jusuru International Receives 2015 DSA Ethos Award 3Health News:Jusuru International Receives 2015 DSA Ethos Award 4Health News:Jusuru International Receives 2015 DSA Ethos Award 5Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 2Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 3Health News:ATA: Congress Floods the Halls with Telemedicine Proposals 2Health News:RowdMap, Inc. Named as a Ernst & Young Entrepreneur Of The Year® 2015 Award Finalist 2
... -- The worldwide incidence of cancer is expected to increase ... than 90 percent in the poorest nations, a new study ... cervical and stomach cancer) appear to be declining in some ... by substantial increases in the types of cancer associated with ...
... , THURSDAY, May 31 (HealthDay News) -- More than ... new government report shows. "Untreated tooth decay is ... Dye, an epidemiologist at the U.S. Centers for Disease ... appears that we haven,t been able to make any ...
... Four University of Houston (UH) students are well on their ... this spring in their work toward new therapies for prostate ... Center for Nuclear Receptors and Cell Signaling (CNRCS), these students ... and expressed, which is vital in developing treatments for cancer. ...
... Philadelphia National data show that currently more than ... obese, and an additional 10 percent are overweight. In ... School of Medicine at the University of Pennsylvania, in ... says that effective strategies to target pregnancy, infancy, and ...
... icon of cleanliness for home and commercial kitchens, restaurants, ... bacteria like other surfaces if not cleaned often. Scientists ... Langmuir , of a practical way to make stainless ... explain that while stainless steel is prized for its ...
... THURSDAY, May 31 (HealthDay News) -- When men are ... their future fertility than women, new Scottish research says. ... information provided to young women diagnosed with cancer and ... fertility expert," study co-author Valerie Peddie, a fertility nurse ...
Cached Medicine News:Health News:Worldwide Cancer Incidence Predicted to Rise 75% by 2030 2Health News:1 in 5 Americans Has Untreated Cavities: CDC 2Health News:Student researchers seek to develop new therapies for cancer 2Health News:Student researchers seek to develop new therapies for cancer 3Health News:Researchers call for obesity prevention efforts to focus on community-wide systems 2Health News:Men and Women With Cancer May Receive Different Fertility Information 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: