Transcept Pharmaceuticals : Preliminary Results From the Intermezzo(R) Highway Driving Study

Oct 19, 2010 - Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced its preliminary analysis of data from the recently completed Intermezzo(R) 3.5 mg (zolpidem tartrate sublingual tablet) highway driving study. Transcept is developing Intermezzo(R) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. In the Intermezzo(R) New Drug Application (NDA), Transcept proposed to the U.S. Food and Drug Administration (FDA) that patients have at least four hours remaining in bed after dosing Intermezzo(R) in the middle of the night.

About the Intermezzo(R) highway driving study

The Intermezzo(R) highway driving study was a double-blind, randomized, placebo-controlled, four-way crossover study of 40 healthy volunteers designed to evaluate the safety profile of Intermezzo(R) with regard to next morning driving. The study evaluated standard deviation of lateral position (SDLP) in a highway driving lane, a surrogate measure for driving performance, as subjects drove an automobile 100 km, or 62 miles, on a public highway under normal traffic conditions for approximately one hour. Subjects performed test drives on placebo, zopiclone as a positive control taken at bedtime nine hours before driving, Intermezzo(R) taken three hours before driving, and Intermezzo(R) taken four hours before driving. Based on a review of the published literature, an SDLP change of 2.5 cm was specified in the protocol as the primary threshold of impairment for the purpose of performing the statistical analyses. In March 2010, the FDA informed Transcept that the statistical methodology proposed by Transcept, a symmetry analysis, was a reasonable approach to measure potential next morning driving impairment... Transcept Pharmaceuticals' Press Release -

Transcept Pharmaceuticals : Clinical Study of Intermezzo® for the Treatment of Middle-of-the-Night Awakening Published in SLEEP

Oct. 22, 2008 - Phase 3 sleep-lab study demonstrated that low dose sublingual Intermezzo^®, used at the time of a middle of the night awakening, significantly shortened time to return to sleep vs. placebo - Transcept Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that a Phase 3 study evaluating the safety and efficacy of its lead product candidate, Intermezzo® (zolpidem tartrate sublingual lozenge), has been published in the September 2008 issue of SLEEP, a publication of the Associated Professional Sleep Societies. Intermezzo® 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... Transcept Pharmaceuticals' Press Release -

Transcept Pharmaceuticals : Intent to Submit New Drug Application for Intermezzo in Q3 2008

June 4, 2008 - Transcept Pharmaceuticals, Inc., a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs, announced 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^® . 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^® 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^® (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... Transcept's Press Release -

Transcept Pharmaceuticals : Study of Intermezzo by Leading Sleep Expert Published in "Human Psychopharmacology"

April 15, 2008: 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 of its lead product candidate,Intermezzo^®, has been published in Human Psychopharmacology. Intermezzo^® (zolpidem tartrate sublingual lozenge) is a low dose formulation of zolpidem designed to treat insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep... Transcept Pharmaceuticals' press Release -

Transcept Pharmaceuticals, Middle-of-the-Night (MOTN) Insomnia

October 1, 2007: Transcept Pharmaceuticals, Inc. announced that Glenn A. Oclassen, President and Chief Executive Officer, will participate in a panel focused on middle-of-the-night (MOTN) insomnia ( form of insomnia that is characterized by patients who awaken in the middle of the night and have difficulty returning to sleep) at the Natixis Bleichroeder “Hidden Gems” Healthcare Conference... Transcept's Press Release -