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

A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Based on the clinical trial data from our two Phase 3 studies and from additional studies of Intermezzo(R), we believe that our low dose, sublingual formulation of zolpidem, which shows rapid onset in clinical studies, has the potential to offer an entirely new approach to the treatment of patients who wake up in the middle-of-the-night and find it difficult to get back to sleep. We look forward to submitting the Intermezzo(R) NDA this fall."

About Middle of the Night Awakenings

Middle-of-the-night (MOTN) or nocturnal awakenings have been reported to be one of the most common sleep problems, affecting approximately one-third of the adult population. According to a recent epidemiological study ("Nocturnal awakenings and comorbid disorders in the American general population" -- Journal of Psychiatric Research (in press), Maurice M. Ohayon, MD, DSc, PhD.), nocturnal awakenings are the most frequently reported insomnia symptom in the general population, with 35 percent of Americans experiencing awakenings at least three times per week and 23 percent waking up at least once every night. Ninety percent of the MOTN insomnia population report that their pattern of nocturnal awakenings persists for at least six months and 50 percent report such insomnia problems lasting more than 5 years. Currently, there is no approved PRN ("taken as needed") treatment for MOTN awakenings.

About Transcept Pharmaceuticals

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs. Transcept development projects leverage new understanding of CNS conditions to provide additional uses and enhanced clinical benefits for existing active agents. The lead Transcept product candidate, Intermezzo(R) (zolpidem tartrate lozenge), is a low dose formulation of zolpidem for the treatment of insomnia in patients who awaken in th
'/>"/>

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:1/23/2015)... Gem Pharmaceuticals announced today that the initial soft tissue ... Phase 2 clinical trial.  This open-label study will assess ... (an investigational medication), in approximately 30 adults as first-line ... Logo - http://photos.prnewswire.com/prnh/20150123/170966LOGO GPX-150 is ...
(Date:1/22/2015)...  BiOptix is pleased to announce the appointment of Dr. ... and Biochemistry. Scott joins the company after previous scientific leadership ... the course of his nearly 20 year career in ... nationally recognized thought leader in the biosensor field and ...
(Date:1/22/2015)... THOUSAND OAKS, Calif. , Jan. 22, 2015  Amgen (NASDAQ: ... quarter and full year 2014 financial results on Tuesday, Jan. 27, ... will be followed by a conference call with the investment community ... be Robert A. Bradway , chairman and chief executive officer, ...
Breaking Medicine Technology:Gem Pharmaceuticals Announces Enrollment of Initial Patients in its Phase 2 Clinical Trial to Assess the Efficacy and Safety of GPX-150 in Sarcoma Patients 2BiOptix Expands Leadership Team with the Appointment of Dr. Scott Klakamp as Vice President of Chemistry and Biochemistry 2Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2
... The Pharmaceutical Care Management Association (PCMA) issued the ... hearing: "The independent drugstore lobby continues ... for themselves in Medicaid while demanding more transparency for ... and retail pharmacy allies in the embarrassing role of ...
... Oxford Finance Corporation (Oxford), a subsidiary of ... Debbie Baker to its Business Development group. As director, ... for life science and medical device companies, primarily in ... 30 years of financial experience, predominantly with the healthcare ...
Cached Medicine Technology:PCMA: Independent Drugstore Lobby Continues 'Disclosure Double Standard' Transparency Campaign 2Oxford Finance Corporation Hires Debbie Baker to Support Life Science Business Development in Western North America 2
(Date:1/22/2015)... York, New York (PRWEB) January 22, 2015 ... http://www.vaginalmeshlawsuit2015.com/ ) in the U.S. District Court, Southern District of ... C.R. Bard, Inc. in that proceeding’s first bellwether trial. In ... request for a new trial after finding that C.R. Bard ...
(Date:1/22/2015)... 20 years, Dr. David Cruz of Cruz Chiropractic Care ... about every type of injury that can result from car accidents ... years, the team at Doctors on Liens has been ... With the combined breadth of experience between the two, ...
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy Champagne wedding ... revenues in the past three years. Today, the business announces ... According to the sales manager of the company, this is ... 2015. This point can be reflected on the discounted wedding ...
(Date:1/22/2015)... January 22, 2015 As interest in the ... care gains momentum worldwide, Rev. Eric J. Hall , ... Network (HCCN), will be the keynote speaker on January ... Israel’s public health system. , The conference, “Hope and Resilience: ...
(Date:1/22/2015)... 2015 State Forestry Institute of Mecklenburg-Vorpommern ... with support from GEOSYSTEMS, a dedicated Hexagon Geospatial and ... leverage Hexagon Geospatial’s ERDAS APOLLO for cataloging, ... as point clouds and documents. This effort will enable ...
Breaking Medicine News(10 mins):Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 2Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 3Health News:Court Upholds $2 Million Vaginal Mesh Lawsuit Verdict Levied Against C.R. Bard in First Federal Bellwether Trial, Bernstein Liebhard LLP Reports 4Health News:Industry Leading Chiropractor in Oceanside Joins the Doctors on Liens Network 2Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 2Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 3
... Iridoids and Other ... ... (TNI) today set itself apart from the superfruits of the world yet again as modern ... plant that enhances the overall ability of the body to adapt to stress. Noni assists ...
... ... Kidney Diseases recommends capsaicin as an effective skin care regimen to help relieve itching associated ... be extremely hot. Now there,s a new skin spray made with the essence of hot ... ...
... ... be a simple matter of getting information about coverage that,s already available ... making concerted efforts to direct the uninsured to coverage, efforts by ordinary ... Charles Smith-Dewey, founder of one of the Web,s most respect health insurance ...
... ... opportunity for educational institutes to discuss their security requirements and compare their current Digital ... , ... (PRWEB) March 4, 2010 -- GlobalSign Inc ( www.globalsign.com ), one of the longest ...
... found that using high-resolution CT-scans to screen for lymphangioleiomyomatosis, or ... who come to the emergency room for the first time ... online ahead of print publication in the American Thoracic Society,s ... Pulmonary LAM is a rare but serious lung ...
... , ... help consumers keep track of their calories by scanning the barcodes on food items has gone ... ... who want to keep track of their daily nutritional intake by scanning the barcodes of items ...
Cached Medicine News:Health News:Tahitian Noni Bioactive Beverages™ Are Adaptogenic 2Health News:Hot Pepper Itch Remedy Targets Kidney Disease Patients Suffering From Chronic Pruritus 2Health News:Consumer Health Insurance Site Founder: Health Reform or No Health Reform, Americans Can Help Reduce Rolls of the Uninsured 2Health News:Consumer Health Insurance Site Founder: Health Reform or No Health Reform, Americans Can Help Reduce Rolls of the Uninsured 3Health News:Consumer Health Insurance Site Founder: Health Reform or No Health Reform, Americans Can Help Reduce Rolls of the Uninsured 4Health News:Consumer Health Insurance Site Founder: Health Reform or No Health Reform, Americans Can Help Reduce Rolls of the Uninsured 5Health News:GlobalSign to Demonstrate Online Security Solutions to Educational Institutes at NERCOMP Conference 2Health News:GlobalSign to Demonstrate Online Security Solutions to Educational Institutes at NERCOMP Conference 3Health News:GlobalSign to Demonstrate Online Security Solutions to Educational Institutes at NERCOMP Conference 4Health News:GlobalSign to Demonstrate Online Security Solutions to Educational Institutes at NERCOMP Conference 5Health News:CT-scan screening for LAM in women with collapsed lung is cost-effective 2Health News:CT-scan screening for LAM in women with collapsed lung is cost-effective 3Health News:Barcode Joins the Battle of the Bulge in New iPhone App 2
Malaria ( P. Falciparum ) Whole Blood Strip / Cassette...
DiaMed OptiMAL-IT is an immuno-chromatographic test, using monoclonal antibodies against the metabolic enzyme pLDH (parasite lactate dehydrogenase) of Plasmodium spp. These Mabs are classified in t...
Core Malaria Pf is a rapid self performing, qualitative, two site sandwich immunoassay for the determination of P. falciparum specific histidine rich protein 2 (Pf HRP-2) in whole blood samples...
Ultraview SL 3800...
Medicine Products: