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:9/19/2014)... St. Paul, Minnesota (PRWEB) September 19, 2014 ... representatives from related food industries will gather October ... Meeting at the Rhode Island Convention Center in ... exhibition will feature the work of food scientists, ... development, quality control, and food production management. To ...
(Date:9/19/2014)... Massachusetts , September 19, 2014 ... the 53rd European Society for Paediatric Endocrinology (ESPE) Meeting  ... of science and medical research in the field of ... Merck KGaA, Darmstadt, Germany , today ... Innovation (GGI) for 2014. The awards were announced during ...
(Date:9/18/2014)... Bipartisan passage this week by the U.S. ... development and commercialization of new technologies and promote growth ... SPIE, the international society for optics and photonics ... (RAMI) Act, now moves to the full Senate for ... optimistic that it will win passage there as well ...
(Date:9/18/2014)... LONDON , Sept. 18, 2014 ... near-patient testing, is performed outside a clinical laboratory. ... hence in administrating appropriate treatments and medication. POCT ... and prevalence of lifestyle diseases such as diabetes, ... and user-friendly. POCT devices are standardized to minimize ...
Breaking Biology Technology:Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 2Latest Research on Cereal Grain Quality, Health Benefits and Food Production to be Presented During the AACC International Annual Meeting 3EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 2EMD Serono Awards Grant for Growth Innovation (GGI) for the First Time 3House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 2House passage of high-tech manufacturing bill is move toward stronger economy, say SPIE leaders 3POCT Market in China 2014-2018 2
... PRXL ) has appointed Charles A. Stevens as ... Strategic Reimbursement Services, a,unit based in the Washington, ... dedicated to helping PAREXEL,s clients provide solutions to ... they require. His,responsibilities include managing reimbursement service and ...
... WOODLANDS, Texas, Dec. 10 Lexicon,Pharmaceuticals, Inc. (Nasdaq: ... management will participate in the RBC Capital Markets,Healthcare Conference ... at The Westin Times Square Hotel in New York, ... Eastern Time., A live audio webcast of the ...
... Nash Corporation,(Nasdaq: KNSY ) is scheduled to participate ... & Tissue" at the 2007 RBC Capital Markets,Healthcare Conference., ... in the panel,discussion on Thursday, December 13th at 8:00 ... in New York. The conference is by invitation only,however ...
Cached Biology Technology:PAREXEL Appoints Charles A. Stevens as Vice President/General Manager of Health Policy and Strategic Reimbursement and Strengthens Capabilities 2PAREXEL Appoints Charles A. Stevens as Vice President/General Manager of Health Policy and Strategic Reimbursement and Strengthens Capabilities 3PAREXEL Appoints Charles A. Stevens as Vice President/General Manager of Health Policy and Strategic Reimbursement and Strengthens Capabilities 4PAREXEL Appoints Charles A. Stevens as Vice President/General Manager of Health Policy and Strategic Reimbursement and Strengthens Capabilities 5Lexicon Pharmaceuticals to Present at RBC Capital Markets Healthcare Conference 2
(Date:9/19/2014)... Jimmy Durante of dinosaurs a newly discovered ... new dinosaur, named Rhinorex condrupus by ... Young University, lived in what is now Utah ... Cretaceous period. , Rhinorex, which translates roughly into ... relative of other Cretaceous hadrosaurs like Parasaurolophus and ...
(Date:9/19/2014)... today by researchers from several Harvard University labs ... experienced and aspiring researchers with the intellectual raw ... made from soft, flexible materials. , With the ... other advances in manufacturing technology, soft robotics is ... drawn from conventional rigid robot design, but working ...
(Date:9/19/2014)... the unique bioelectric signaling system of the electric fish, ... The OU researcher is working to understand how these ... used to map the world around them. Electric ... discharges a second throughout their lives. The energetic ... necessary for survival. , "There is evidence that electric ...
Breaking Biology News(10 mins):New hadrosaur noses into spotlight 2Soft robotics 'toolkit' features everything a robot-maker needs 2
... (SALT LAKE CITY)Alternating hemiplegia of childhood (AHC) is a ... episodes of paralysis and stiffness, first affecting one side ... and disappear, again and again, and affected children often ... older, children fall progressively behind their peers in both ...
... smog-filled sky or a contaminated river, according to a ... for the prosperous. People living in China,s cities ... more likely to begreen: re-using their plastic grocery bags ... the international journal AMBIO , indicates that the ...
... doesn,t mean making a trip to the local pharmacy for ... the forest to provide a pharmacopeia of medicines to ... But while questions persist about whether such natural remedies are ... examining the phenomenon from a unique perspective, and trying to ...
Cached Biology News:Gene mutations linked to most cases of rare disorder -- Alternating Hemoplegia of Childhood 2Gene mutations linked to most cases of rare disorder -- Alternating Hemoplegia of Childhood 3Pollution can make citizens - both rich and poor - go green 2Health care savings, naturally 2Health care savings, naturally 3
... Jouan MSC series of Class II ... conditions and certification to the world's ... ensures that the cabinets cannot be ... Natural lighting, low noise and arm ...
... Fluoroskan Ascent is a dedicated ... for all kinds of assays ... and for clinical applications. Cell ... are all important application areas. ...
... A sleek design loaded with class-leading features, the ... that your work is safe and consistent every time ... the new 1400 Series reduces power consumption by as ... of dollars over the life of the cabinet. ...
... The Magnetic Stand-96 is designed for paramagnetic ... and 0.2 ml PCR plates with no ... polyacryl base in a standard SBS 96-well ... strong permanent magnets guarantees easy and fast ...
Biology Products: