Pharmacokinetic and Pharmacodynamic Data Support Potential of Intermezzo(R) in the Treatment of Middle-of-the-Night Insomnia
PT. RICHMOND, Calif., April 15 /PRNewswire/ -- 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(R), has been published in Human Psychopharmacology. Intermezzo(R) (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.
Led by Thomas Roth, Ph.D., Director of the Henry Ford Hospital Sleep Disorders and Research Center, the double-blind, placebo-controlled, cross-over study examined 24 healthy men and women aged 21 - 44 with no current self-reported sleeping problems. The objective of the study was to evaluate the pharmacokinetics and daytime-sedation profile of Intermezzo(R) at doses of 1.75, 3.5 mg and placebo. Intermezzo(R) was rapidly absorbed and reached maximum plasma concentrations within 38 minutes of dosing. Results showed that at doses of 1.75 and 3.5 mg, Intermezzo(R) produced significant sedation within 20 minutes of dosing, with the sedative effect lasting 3 to 4 hours.
Dr. Roth commented, "Difficulty returning to sleep after awakening in the middle of the night is a common complaint among insomnia patients. The currently available sleep medications are indicated to be taken before sleep initiation. In contrast, sublingual zolpidem is designed to be used when patients wake up in the middle of the night and have difficulty returning to sleep. This study supports other clinical trial data suggesting that this medication may be a good candidate for the treatment of nocturnal awakening episodes because of its combination of low dose, rapid onset and shorter duration of effect."
About Transcept Pharmaceuticals
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company deriving significant new patient benefits from proven CNS drugs. Transcept development projects leverage new understanding of CNS conditions to provide additional uses and enhanced clinical benefits for existing active agents. The lead Transcept product candidate, Intermezzo(R) (zolpidem tartrate sublingual lozenge), is a low dose formulation of zolpidem for the treatment of insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep. Phase 3 clinical trials have been completed for Intermezzo(R) and Transcept plans to submit an NDA in the third quarter of 2008. Transcept is also developing TO-2060, a novel, fixed-dose combination of olanzapine and ondansetron for the treatment of dopamine associated psychiatric disorders. For further information, please visit the company's website at: http://www.transcept.com/.
About Human Psychopharmacology
Human Psychopharmacology is a multi-disciplinary journal focusing all on aspects of psychopharmacology relevant to human experimental research and clinical medicine. A reprint of the study can be purchased online: http://www3.interscience.wiley.com/cgi-bin/abstract/116325141/ABSTRACT
Contacts:
Transcept Pharmaceuticals, Inc.
Michael Gill
Director of Communications
(510) 215-3575
The Ruth Group
Investors / Media
Stephanie Carrington / Jason Rando
(646) 536-7017 / 7025
scarrington@theruthgroup.com
jrando@theruthgroup.com
Transcept Pharmaceuticals, Inc.
