Navigation Links
Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
Date:10/1/2008

Intermezzo(R) (zolpidem tartrate sublingual lozenge) developed to be the

first sleep aid specifically for use in the middle of the night when

patients awaken and have difficulty returning to sleep

PT. RICHMOND, Calif., Oct. 1 /PRNewswire/ -- 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(R) (zolpidem tartrate sublingual lozenge). Intermezzo(R) is a low dose, buffered, sublingual formulation of zolpidem intended to be the first prescription sleep aid to be indicated for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The Intermezzo(R) NDA submission 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. This objective study demonstrated that the Intermezzo(R) 1.75 mg and 3.5 mg doses, when used at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo, and there was no evidence of next day residual sedative effects with either dose. Transcept believes that these are the lowest zolpidem doses that have been reported to be statistically superior to placebo in producing sleep. When patients used the 3.5 mg dose, the study also indicated statistically significant improvements in total sleep time, sleep efficiency, subjective number of post-dose awakenings, sleep quality, level of refreshed sleep, and next day ability to function.

The second Phase 3 clinical trial was a double-blind, placebo-controlled outpatient study in which 294 patients used either In
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
2. Critical Pharmaceuticals Enter Sustained Release hGH Arena
3. Anadys Pharmaceuticals to Present at the JMP Securities Healthcare Focus Conference
4. Potentia Pharmaceuticals Announces Positive Safety Data and Study Expansion in Phase I Trial for Lead Drug Candidate POT-4
5. Quark Pharmaceuticals Announces First RNAi Drug Candidate Having a Novel, Proprietary Structure Covered by Quark Intellectual Property
6. Lotus Pharmaceuticals, Inc.s New Drug Laevo-Bambutero Begins Evaluation for Clinical Trials
7. VIA Pharmaceuticals Completes Patient Visits in Phase 2 Acute Coronary Syndrome (ACS) Trial
8. QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
9. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
10. Oramed Pharmaceuticals Commences Phase 2A Trials of its Oral Insulin Capsule on Type 1 Diabetics
11. Vion Pharmaceuticals Enters into Agreement to Conduct a Phase I/II Clinical Trial of Cloretazine(R) in Combination with Induction Therapy in Poor Prognosis AML Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... International Trade Commission (ITC) issued its final decision in the ... notice issued on December 23, the ITC ruled in favor ... was invalid. BMC President, James Xu ... with the ITC,s decision in this case. This victory for ... very beginning on the key patents in the case. ResMed ...
(Date:12/24/2014)... and FARMINGTON, Conn. ... Inc. (NYSE MKT: PTN), a biopharmaceutical company developing ... diseases with significant unmet medical need and commercial ... a private placement of 2,050,000 shares of its ... 24,949,325 shares of its common stock.  Funds under ...
(Date:12/24/2014)... Dec. 23, 2014 Echo Therapeutics, Inc. ... company focused on skin permeation, continuous glucose monitoring ... W. Hollander has been appointed Chief Executive ... more than 20 years of experience in the ... most recently served as Vice President, Business Development, ...
Breaking Medicine Technology:ITC Final Decision Goes Against ResMed (RMD) Monumental Win for 3B/BMC 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 2Palatin Completes $20 Million Equity and $10 Million Debt Financings 3Palatin Completes $20 Million Equity and $10 Million Debt Financings 4Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 2Echo Therapeutics Announces Scott W. Hollander as President & Chief Executive Officer 3
... DIEGO, June 8, 2011 Otonomy, Inc., ... of the ear, today announced positive results for OTO-201, ... in multiple preclinical studies evaluating the treatment of middle ... placement surgery.  Approximately one million tube placement procedures are ...
... NORTH KINGSTOWN, R.I., June 8, 2011 Leading national ... Tufts Health Care Institute,s (THCI) Program on Opioid Risk ... support of THCI,s Program on Opioid Risk Management began ... promoting the safe and effective use of controlled opioid ...
Cached Medicine Technology:Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure 2Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure 3Otonomy Announces Preclinical Results Supporting Intra-operative Use of OTO-201 for Common Childhood Procedure 4Dominion Diagnostics Supports Opioid Risk Management Program for Fourth Consecutive Year 2
(Date:12/26/2014)... 26, 2014 The Biofeedback Federation of ... 24-28, 2015 in Rome, Italy and is hosted by ... workshops on a wide variety of topics such ... peak performance training in athletes. The scientific program will ... , Biofeedback monitoring allows clients to see what is ...
(Date:12/26/2014)... 2014 DW-InductionHeating.com (DaWei Induction Heating Co.) ... and developing, producing and marketing of a series of ... announces their new series of induction brazing equipments ... company, induction brazing refers to the joining ... material and heat. The manager says that there are ...
(Date:12/25/2014)... 2014 The report “Nintedanib (Colorectal ... focuses on the current treatment landscape, unmet needs, ... cancer market. Stivarga is a drug which is ... cancer. Boehringer Ingelheim is developing nintedanib (BIBF-1120), an ... refractory CRC in the US, Europe, and Japan. ...
(Date:12/25/2014)... (PRWEB) December 26, 2014 Recently, Dylan ... dresses, has excitedly released its collection of discounted prom ... to Percy, a senior spokesman of the company, the ... of this promotion is to expand the UK market. ... in several different colors, lengths, and styles: A-line strapless, ...
(Date:12/25/2014)... 25, 2014 When head lice hits a ... a frenzy to get rid of it while keeping it ... Coral Gables now have the solution right in their neighborhood: ... location, Lice Troopers provides full spectrum head lice screening and ... area, including Sunset, Key Biscayne, Brickell, Coconut Grove, Kendall, Pinecrest ...
Breaking Medicine News(10 mins):Health News:Final Workshop Line-up Announced for 18th Annual Biofeedback Conference in Rome, Italy 2Health News:Induction Brazing Equipment Series From DaWei Induction Heating Co., A Reliable Supplier Of Induction Heating Equipment 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Nintedanib Colorectal Cancer Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 4Health News:Dylan Queen: Cheap Prom Dresses for the UK Market 2Health News:Coral Gables Florida Gets Ready to Be Lice-Free with Lice Troopers 2
... and Ohio Farm Bureau,Federation (OFBF) have announced a ... OFBF,s more than 230,000 members. Effective January ... to,Medical Mutual,s SuperMed provider network, the most comprehensive ... in Ohio. Medical,Mutual and OFBF have worked together ...
... a Flu Shot, HARRISBURG, Pa., Nov. 8 ... of influenza this,season, the state Health Department said today., ... carries with it a,reminder to all Pennsylvanians to take ... Health Secretary Dr. Calvin B.,Johnson said. "While this is ...
... it eased shoulder pain caused by osteoarthritis , , THURSDAY, Nov. ... pain in arthritis sufferers, a preliminary study found. , "We ... definitive study," said study author Dr. Jasvinder Singh, a staff ... study was small, and more patients needed to be assessed ...
... switch is involved in the development of a common ... breast cancer. The research, published by Cell Press in ... an exciting paradigm shift in the understanding of a ... therapeutic opportunities for this deadly disease. , Locally ...
... (Nov. 8, 2007) Virginia Commonwealth University researchers have ... play a major role in clotting disorders, which could ... lungs and those localized deep in the body in ... when the effect of thrombin, a protein involved in ...
... The Connecticut,Trial Lawyers Association (CTLA) today released a ... Medical Insurance Company,(CMIC) has been charging doctors excessive ... to the growing cost of Connecticut,health care., ... New Jersey,independent actuarial firm, is based on the ...
Cached Medicine News:Health News:Ohio Farm Bureau Health Plan Awarded to Medical Mutual of Ohio 2Health News:Ohio Farm Bureau Health Plan Awarded to Medical Mutual of Ohio 3Health News:Health Department Reports State's First Lab-Confirmed Influenza Case of the Season 2Health News:Botox Offers Shot in Arm for Arthritis Sufferers 2Health News:Researchers identify unusual molecular switch for common form of advanced breast cancer 2Health News:Researchers identify molecules with interesting anti-clotting properties 2Health News:Connecticut Trial Lawyers Ask Doctors to Question Insurer's Excess Profits 2
... Keratometer now utilizes LED technology ... removing the need to ever ... change are all the great ... Keratometer the worldwide instrument of ...
4 hour identification of over 70 medically important, oxidase-negative, gram-negative bacilli, including E. coli, based on enzyme technology....
For presumptive identification of E. coli serogroup O157:H7 cultured on laboratory media....
A direct qualitative enzyme immunoassay for detection of E.coli Shiga Toxin 1 and 2 in fresh or preserved fecal specimens....
Medicine Products: