Navigation Links
Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo(R)
Date:12/16/2008

FDA to review Intermezzo(R) (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings

PT. RICHMOND, Calif., Dec. 16 /PRNewswire/ -- Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for Intermezzo(R) (zolpidem tartrate sublingual lozenge) has been accepted for review by the agency. Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "Confirmation that the FDA has accepted the Intermezzo(R) NDA and has begun its review represents another important milestone in our efforts to gain FDA approval for Intermezzo(R), which we believe is positioned to be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Based on an anticipated standard review process, we currently expect to receive a complete response letter regarding Intermezzo(R) in the fourth quarter of 2009 and to initiate the potential U.S. commercialization and launch in the first half of 2010, if Intermezzo(R) is approved."

The Intermezzo(R) NDA 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. Results from the study dem
'/>"/>

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

Page: 1 2 3 4 5

Related biology technology :

1. Transcept Pharmaceuticals to Participate in Middle-of-the-Night (MOTN) Insomnia Investor Panel
2. Transcept Pharmaceuticals Appoints Key Senior Executives
3. Transcept Pharmaceuticals, Inc. to Present at the Natixis Bleichroeder Second Annual Hidden Gems Conference
4. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
5. China Biopharmaceuticals Holdings Announces Second Quarter 2007 Financial Results
6. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
7. XTL Biopharmaceuticals Announces Financial Results for the Six Months Ended June 30, 2007
8. Cadence Pharmaceuticals Reports Second Quarter 2007 Financial Results
9. Nabi Biopharmaceuticals to Present at Upcoming Industry Conferences
10. Anadys Pharmaceuticals Appoints Steve Worland, Ph.D. as President and Chief Executive Officer
11. Poniard Pharmaceuticals Announces Participation in Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Shimadzu Scientific Instruments today announces the ... Offering wavelength scanning from 190 to 1,100 nm, ... in a variety of industries, including environmental, food ... enables intuitive operation, while the enhanced validation, maintenance ...
(Date:1/22/2015)... January 21, 2015 Cambridge Semantics, the leading ... today announced that 2014 was a record-breaking year across the ... of the Anzo Smart Data Platform and our Smart Data ... insights from diverse data which led to record growth for ...
(Date:1/22/2015)... 22, 2015 Pipette.com has added the ... their comprehensive portfolio of Eppendorf products. , The Eppendorf ... a Centrifuge 5424/5424 R and receive the following:, ... Research plus or Eppendorf Reference 2 , ...
(Date:1/22/2015)... Switzerland (PRWEB) January 22, 2015 Selexis ... characterized mammalian Research Cell Banks (RCBs) used for drug ... Research Cell Banks will include Next-Generation Sequencing ... genetic architecture de-risks biologic manufacturing by ensuring the integrity ...
Breaking Biology Technology:Shimadzu’s New Monitored Single-Beam UV-Vis Spectrophotometer Offers Comprehensive Measurement Options in a Compact Body 2Cambridge Semantics Announces Record Results for 2014 2Eppendorf Announces Promotional Bundle Which Includes: Eppendorf Centrifuge 5424, 3-Pack of Pipettes, and Tips - Available Now at Pipette.com 2Selexis Generated Research Cell Banks Now Fully Sequenced Using Next-Generation Sequencing 2
... , SEATTLE, Aug. 11 Omeros Corporation ... trial of OMS302, the Company,s ophthalmologic PharmacoSurgery(TM) product candidate. ... and an agent that causes pupil dilation (mydriasis), each ... Omeros, Phase 1/Phase 2 trial enrolled 61 ...
... QUEBEC CITY, Aug. 11 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: ... focused on endocrinology and oncology, today reported financial and operating results ... 30, 2009. , , , Second Quarter ... poster presentations at the American Association of Cancer, ...
... ... at the Center for Orthopedics in Sheffield Village, Ohio, now offers OtisKnee® Custom Fit ... better implant fit and alignment -- and a faster return to an active lifestyle. ... Sheffield Village, ...
Cached Biology Technology:Omeros Announces Positive Clinical Results of Phase 1/Phase 2 Trial of OMS302 for Use During Ophthalmologic Surgery 2AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 2AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 3AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 4AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 5AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 6AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 7AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results 8William Stanfield, MD, Is First Cleveland-area Orthopedic Surgeon to Perform OtisKnee Custom Fit Knee Replacement 2William Stanfield, MD, Is First Cleveland-area Orthopedic Surgeon to Perform OtisKnee Custom Fit Knee Replacement 3William Stanfield, MD, Is First Cleveland-area Orthopedic Surgeon to Perform OtisKnee Custom Fit Knee Replacement 4
(Date:12/22/2014)... SHELTON, Conn. , Dec. 22, 2014  NXT-ID, Inc. (NASDAQ: ... a biometric authentication company focused on the growing mobile commerce ... consultant, Apollo Robbins for the 2015 International CES ... Apollo Robbins will be at the NXT-ID booth ...
(Date:12/19/2014)... 2014  23andMe, Inc., the leading personal genetics company, today announced ... genetic ancestry of individuals from across the United ... than four hundred years ago, the United States ... from different continents. This study illuminates how American history and ...
(Date:12/17/2014)... Dec. 16, 2014 Valencell, a leader in performance ... technology to industry leaders such as Intel, Jabra, Atlas, ... biometric wearable products. These products will be showcased at ... Las Vegas . "Our partners ...
Breaking Biology News(10 mins):NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 2NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 3NXT-ID Hires Master Pickpocket and Security Consultant Apollo Robbins for Wocket Smart Wallet CES 2015 Debut 423andMe Study Sketches Genetic Portrait of the United States 223andMe Study Sketches Genetic Portrait of the United States 323andMe Study Sketches Genetic Portrait of the United States 4Valencell PerformTek Biometrics Power the Most Accurate Wearables at CES 2015 2
... six billion base pairs from the genome of one person ... the J. Craig Venter Institute (JCVI), along with collaborators at ... of California San Diego (UCSD), have published a genome sequence ... chromosomes that were inherited from each parent. ...
... The immune response is actively turned on to target and ... it is just as important to turn the immune system ... fruit fly Drosophila has served as a good model for ... pathways and mechanisms. Recent work shows that the flys immune ...
... The earliest domesticated pigs in Europe, which many archaeologists ... actually introduced from the Middle East by Stone Age ... international team led by archaeologists at Durham University, which ... the National Academies of Sciences USA, analysed mitochondrial DNA ...
Cached Biology News:First individual genome sequence published 2First individual genome sequence published 3First individual genome sequence published 4Pig study sheds new light on the colonisation of Europe by early farmers 2
... of cytoplasmic granules, is a key ... leukocytes (e.g. basophils, neutrophils, eosinophils, and ... these secretory granules contain many proinflammatory ... many proteases (Hallgren, 2001). Tryptase, a ...
... DNA gel stain was developed specifically for reduced ... for staining DNA in agarose or acrylamide gels. ... than ethidium bromide but SYBR Safe stain's detection ... SYBR Safe stain comes as a premixed solution ...
... enables scientists who do not have access to ... have their biological samples tested for the concentration ... as 1-2-3 Chose the analytes you ... the S&S antibody menu. Send your samples ...
... nucleic acid gel stain is an exceptionally ... fluorescence when bound to dsDNA and low background ... in gels using laser scanners or standard UV ... also found uses in capillary electrophoresis, real-time PCR ...
Biology Products: