Topic: Transcept Pharmaceuticals Inc.
The US Food and Drug Administration, for the first time, approved Wednesday medication specifically designed for those who wake up in the middle of the night and cannot fall back to sleep.Intermezzo, manufactured by Transcept Pharmaceuticals of California, is a lower-dose formulation ...
Two stocks of note in the past week are Jazz Pharmaceuticals (JAZZ) and Transcept Pharmaceuticals (TSPT). html" rel="nofollow">Jazz Pharmaceuticals Running On Buy From Smart Investor).. Transcept Pharma announced earlier from Glenn A. Oclassen, President and Chief Executive Officer commented, "Our overall staffing ...
Transcept Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today the presentation of data from a clinical study of in two posters at ...
Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo
FDA to review Intermezzo (zolpidem tartrate sublingual lozenge) as the first sleep aid specifically designed for the treatment of middle-of-the-night awakenings. Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has received confirmation from the U.S. Food and Drug ...
Phase 3 sleep-lab study demonstrated that low dose sublingual Intermezzo(R), used at the time of a middle of the night awakening, significantly shortened time to return to sleep vs. On September 30, 2008, Transcept submitted a New Drug Application for Intermezzo(R) to ...
Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, Intermezzo (zolpidem tartrate sublingual lozenge). This NDA submission is the ...
Data Presented as Poster Presentation at the Associated Professional Sleep Societies 2008 Annual Meeting Data was presented today at the 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS) demonstrating that within 20 minutes of administration, Intermezzo(R), an investigational low-dose, sublingual ...
Company Reports Positive Top-line Results from Second Phase 3 Study of Intermezzo(R) - 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 ...
Pharmacokinetic and Pharmacodynamic Data Support Potential of Intermezzo(R) in the Treatment of Middle-of-the-Night Insomnia Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced today that a study evaluating the pharmacodynamics, pharmacokinetics, and tolerability profile ...