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:9/30/2014)... , Sept. 30, 2014 BioStructures, ... the American Association of Tissue Banks (AATB), it ... Chief Executive Officer. Accreditation follows an ... a specially trained AATB inspector.  It establishes that ... within the facility meets or exceeds the standards ...
(Date:9/30/2014)... , Sept. 30, 2014  Georgia-Pacific Professional ... towels and tissue for a wide range of ... of its product lines in healthcare, including hospitals, ... Georgia-Pacific Professional is introducing its healthcare products and ... Professional understands the importance of infection control in ...
(Date:9/30/2014)... , Sept. 30, 2014 Passport Health, one ... , has launched FluFree.com, a website designed to ... For 20 years, Passport Health has provided ... flu. The launch of FluFree.com is designed to address ... the number of people who actually chose to get ...
Breaking Medicine Technology:Biostructures, LLC Earns AATB Accreditation 2Georgia-Pacific Professional Brings Its Success in Medical Solutions to the Dental Community 2Georgia-Pacific Professional Brings Its Success in Medical Solutions to the Dental Community 3Passport Health Launches FluFree.com - Aims To Improve Flu Vaccination Rates and Fulfill Growing Public Health Priority 2Passport Health Launches FluFree.com - Aims To Improve Flu Vaccination Rates and Fulfill Growing Public Health Priority 3
... Jan. 23, 2012  PLC Systems Inc. (OTC: PLCSF), a ... successful enrollment of the first patient in the CIN-RG ... of its RenalGuard Therapy® and RenalGuard System™ in the ... step in the process to secure regulatory approval by ...
... EntreMed, Inc. (Nasdaq: ENMD ), a ... of cancer, announced today that it has secured ... including IDG-Accel China Growth Fund II L.P. ("IDG"), ... W. Mak, Director of The Campbell Family Institute ...
Cached Medicine Technology:First Patient Treated in PLC Systems' RenalGuard® U.S. Pivotal Trial 2First Patient Treated in PLC Systems' RenalGuard® U.S. Pivotal Trial 3EntreMed Secures $10 Million Strategic Financing 2EntreMed Secures $10 Million Strategic Financing 3EntreMed Secures $10 Million Strategic Financing 4EntreMed Secures $10 Million Strategic Financing 5
(Date:9/30/2014)... September 30, 2014 A group of Americans ... combat an epidemic that, left unchecked, could create a catastrophic, ... not headed to Africa. John Rogers, the Executive Director the ... Korea to fight a disease most think mankind conquered long ... 80 years ago is on the comeback in several countries ...
(Date:9/30/2014)... Beach, Florida (PRWEB) September 30, 2014 Two ... make the treatment of gum disease a far ... of the past. , “If you’ve ever felt electric shock ... cream or sip a cold beverage, it’s possible you already ... Salisbury , who is a general dentist in West Palm ...
(Date:9/30/2014)... 2014 (HealthDay News) -- Medicare should cover low-dose computed ... for the disease, a coalition of more than 60 ... includes the Lung Cancer Alliance, the Society of Thoracic ... Society and the American Society of Clinical Oncology, made ... U.S. Centers for Medicare & Medicaid Services (CMS). ...
(Date:9/30/2014)... of Defense has made progress in reducing the stigma ... depression and post-traumatic stress disorder, but more improvement is ... , Despite efforts of both the Defense Department and ... many service members still do not seek needed care ... a concerted effort to promote treatment as a way ...
(Date:9/30/2014)... ANN ARBORThe discovery of a gene mutation that causes ... development of drugs that block the rapid, unstoppable cell ... at the University of Michigan and the U-M Health ... devastating disease dyskeratosis congenita, in which precious hematopoietic stem ... DC age prematurely and are prone to cancer and ...
Breaking Medicine News(10 mins):Health News:US Delegation Heads to North Korea to Combat Tuberculosis Epidemic 2Health News:Florida Dentist Battles Gum Disease With Latest Techniques 2Health News:Florida Dentist Battles Gum Disease With Latest Techniques 3Health News:Groups Call for Medicare Coverage of Lung Cancer Screening 2Health News:US military making progress reducing stigma tied to seeking help for mental illness 2Health News:US military making progress reducing stigma tied to seeking help for mental illness 3Health News:Disease decoded: Gene mutation may lead to development of new cancer drugs 2
... , TUESDAY, Jan. 12 (HealthDay News) -- An experimental ... study shows. , The drug, DBZ, currently in clinical ... have side effects on the lining of the lower ... to those seen in Barrett,s esophagus, a condition that ...
... two ,good, copies slows age-linked mental decline by half, study ... variant that is good for the heart also appears to ... function and cutting the odds for Alzheimer,s disease, a study ... form of the gene, it reduces the risk of Alzheimer,s ...
... ... and Normal Lives Due to Groundbreaking Gene Therapy, , ... Cambridge, MA (Vocus) January 12, 2010 -- Genetix Pharmaceuticals, a leader ... ALD gene therapy research recently published by its collaboratiors at National Institute of Health and ...
... , WATERTOWN, Mass. , Jan. 12 ... cardiovascular system is also good for the brain, according to ... been braving cold temperatures to get in shape for the ... are encouraging others to keep in shape as well. , ...
... 5, 2010An enzyme that normally helps break down stored ... them more malignant, according to new findings by a ... has focused on the mechanisms leading to cancer formation ... says Benjamin Cravatt, chair of the Scripps Research Department ...
... , , SHENZHEN, China , ... www.htdsmedical.com ) announced that its directors have resolved that up ... sale of its MindUp division to Hiru will be distributed to ... Terry Yuan , HTDS President, said, "In our efforts to maximize ...
Cached Medicine News:Health News:Gene Variant Could Lower Alzheimer's Risk 2Health News:Gene Variant Could Lower Alzheimer's Risk 3Health News:Genetix Pharmaceuticals' Adrenoleukodystrophy (ALD) Product Recognized As One of Science Magazine's Top 10 Scientific Breakthroughs of 2009 2Health News:Genetix Pharmaceuticals' Adrenoleukodystrophy (ALD) Product Recognized As One of Science Magazine's Top 10 Scientific Breakthroughs of 2009 3Health News:The Run for the Memory Marathon Team Getting in Shape and Fighting Alzheimer's 2Health News:The Run for the Memory Marathon Team Getting in Shape and Fighting Alzheimer's 3Health News:The Run for the Memory Marathon Team Getting in Shape and Fighting Alzheimer's 4Health News:Scripps Research scientists find cancer cells co-opt fat metabolism pathway to become more malignant 2Health News:Scripps Research scientists find cancer cells co-opt fat metabolism pathway to become more malignant 3Health News:Hard To Treat Diseases (HTDS) To Disperse Special One Time Hiru (HIRU) Common Stock 2Health News:Hard To Treat Diseases (HTDS) To Disperse Special One Time Hiru (HIRU) Common Stock 3Health News:Hard To Treat Diseases (HTDS) To Disperse Special One Time Hiru (HIRU) Common Stock 4
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... 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 ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: