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

- Company Reports Positive Top-line Results from Second Phase 3 Study of

Intermezzo(R) -

PT. RICHMOND, Calif., June 4 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that it has completed all pivotal and supporting clinical trials that will be included in the new drug application (NDA) for its lead product candidate, Intermezzo(R). Following its pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on April 2, 2008, Transcept now expects to submit the Intermezzo(R) NDA in the third quarter of 2008.

Transcept's meeting with the FDA was triggered by the Company's successful completion of a second Phase 3 clinical trial of Intermezzo(R) (3.5 mg zolpidem tartrate sublingual lozenge), a low dose buffered sublingual formulation designed to treat insomnia in patients who awaken in the middle-of-the-night (MOTN) and have difficulty returning to sleep. The randomized, double-blind, placebo-controlled outpatient study involving 294 patients met its primary endpoint of significantly reducing time to sleep onset vs. placebo.

In addition to the Phase 3 outpatient study, Transcept has also completed a Phase 3 double-blind, placebo-controlled crossover sleep-lab study of Intermezzo(R) involving 82 insomnia patients. As announced in June 2007, the sleep-lab study demonstrated that Intermezzo(R) 3.5 mg significantly shortened time to sleep onset in comparison to placebo in patients experiencing middle-of-the-night awakenings. Compared to placebo, patients on the 3.5 mg dose also reported statistically significant improvements in total sleep time, sleep efficiency, subjective number of awakenings post-dose, sleep quality, refreshing sleep, and next day ability to function. Overall, Intermezzo(R) was well tolerated in both Phase 3 studies, and exhibited a safety profile similar to placebo.

Glenn 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 the middle of the night and have difficulty returning to sleep. Transcept is also developing TO-2060, a novel, fixed-dose combination of olanzapine and ondansetron for the treatment of dopamine associated psychiatric disorders. For further information, please visit the Company's website at: http://www.transcept.com.

Contacts:

Transcept Pharmaceuticals, Inc. The Ruth Group

Michael Gill Investors / Media

Director of Communications Stephanie Carrington / Jason Rando

(510) 215-3575 (646) 536-7017 / 7025

scarrington@theruthgroup.com

jrando@theruthgroup.com


'/>"/>
SOURCE Transcept Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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:6/24/2016)... 24, 2016 ... the addition of the " Global Markets for ... This report focuses on ... updated review, including its applications in various applications. The ... which includes three main industries: pharmaceutical and biotechnology, food ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American ... function testing company, is now able to perform sophisticated lung assessments ... ndd Medical Technologies , Inc. Patients are no ...  Thanks to ndd,s EasyOne PRO ® , ARL patients like Jeanne ... needed testing done in the comfort of her own home. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... Austin residents seeking Mohs surgery services, can now turn to Dr. Jessica Scruggs ... for medical and surgical dermatology. , Dr. Dorsey brings specialization to include Mohs surgery, ... Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn Goldstein, MD, ...
(Date:6/25/2016)... ... ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize each ... Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into hand ... select a ProHand generator and drag it above media or text in the Final ...
(Date:6/25/2016)... ... , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors ... Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green ... hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, ... at Work award to iHire in recognition of their exemplary accomplishments in worksite health ... annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published ... unfamiliar with. The article goes on to state that individuals are now more comfortable ... less common operations such as calf and cheek reduction. The Los Angeles area medical ...
Breaking Medicine News(10 mins):