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 -
Thursday, June 12, 2008
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 -
