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:7/1/2017)... WARSAW, Ind. , June 30, 2017 Zimmer ... second quarter sales and earnings conference call will be broadcast ... 8 a.m. Eastern Time.  A news release detailing the quarterly ... the morning of the conference call. The live ... website at http://investor.zimmerbiomet.com . It will be archived for ...
(Date:6/30/2017)... , June 29, 2017  Axium Pharmaceuticals Inc. is a pharmaceutical ... novel formulations and alternative dosage forms of existing biologically active ... ... on our waterless self-nano emulsifying formula, which is designed to ... We believe the spray will provide fast onset of action ...
(Date:6/20/2017)... LAGUNA HILLS, Calif. , June 20, 2017 /PRNewswire/ ... validate the use of MMprofiler with SKY92, the company,s ... (MM). In a poster presentation at the 22 nd ... Madrid, Spain , SkylineDx researchers will ... elderly patients. In a separate e-poster ...
Breaking Medicine Technology:
(Date:7/20/2017)... ... July 20, 2017 , ... ... enterprise-grade IT operations analytics and application performance monitoring (APM) solutions, has expanded ... healthcare services providers. , According to Peter Ohrenberger, sales director at Nastel, ...
(Date:7/20/2017)... ... ... For individuals with extended hospital stays or who are residents of nursing homes, ... designed to accommodate patients with a wide range of ailments or special needs, but ... invented the patent-pending PORTABLE ARM REST, a specially designed armrest that features many uses, ...
(Date:7/20/2017)... , ... July 20, 2017 , ... Team Type 1 ... to medicine for everyone affected by diabetes, is teaming up with a Microsoft Corp. ... event kicks off on July 24th. , “Team Type 1’s mission overlaps seamlessly ...
(Date:7/20/2017)... ... July 20, 2017 , ... ... development of non-invasive devices and systems for monitoring cardiopulmonary diseases, announced today that ... be used to complete regulatory submissions and fund final engineering and initial production ...
(Date:7/20/2017)... ... July 20, 2017 , ... Using CDRH’s Medical Device ... — 1:30 p.m. – 3:00 p.m. ET, http://www.fdanews.com/mdqualitydata          , Device makers ... It’s known as the “CY2016 Annual FDA Medical Device Quality System Data” report. ...
Breaking Medicine News(10 mins):