Analyses of Efficacy and Absence of Rebound Effect in a Clinical Study of Intermezzo(R) (Zolpidem Tartrate Sublingual Tablet 3.5 mg) to Treat Middle-of-the-Night (MOTN) Awakening on an As-Needed Basis
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), 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 Intermezzo(R) in two posters at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies in Seattle, Washington. Intermezzo(R) is a sublingual low dose formulation of zolpidem currently under regulatory review by the U.S. Food and Drug Administration (FDA). If approved within the anticipated time frame, Intermezzo(R) will be the first commercially available sleep aid designed specifically for use as-needed in the middle of the night when patients awaken and have difficulty returning to sleep.
The first poster, titled "As-Needed Treatment of Insomnia Following MOTN Awakening: Clinical Efficacy of Low-Dose Zolpidem Tartrate Sublingual Tablet," was presented on June 8, 2009 by Thomas Roth, Ph.D., Chief of Sleep Medicine, Henry Ford Hospital Sleep Disorders and Research Center. The purpose of the study was to evaluate the efficacy of zolpidem tartrate sublingual tablet 3.5 mg (ZST) when taken on an as-needed (prn) basis during a one-month period of time for the treatment of middle-of-the-night (MOTN) awakenings followed by difficulty returning to sleep.
In the study, 295 adults (aged 18 to 64 years) with insomnia characterized by MOTN awakenings and difficulty returning to sleep were randomized to receive four weeks of double-blind treatment with either ZST or placebo. Study medication was to be taken only when needed (prn) at the time of awakening with difficulty returning to sleep. The study included a two-week, single-blinded, placebo screening period. An interactive voice response system (IVRS) was utilized for patient data collection. Results indicated that, compared to placebo, ZST significantly reduced latency to sleep onset after MOTN awakenings and improved sleep quality and next-day alertness ratings throughout the treatment period. Furthermore, ZST improved the post-MOTN sleep maintenance parameters of wake after sleep onset and number of awakenings versus placebo. The 3.5 mg zolpidem tartrate sublingual tablet was well tolerated and no safety issues were identified.
The second poster, titled "Absence of Rebound Effects with Low-Dose Zolpidem Tartrate Sublingual Tablet 3.5 mg As-Needed Use: Preliminary Analysis," was presented on June 8, 2009 by Russell Rosenberg, Ph.D., Founder and Director of NeuroTrials Research and the Atlanta School of Sleep Medicine. This poster presents the results of post hoc analyses to evaluate whether rebound effects occurred in the study described above. Rebound is typically defined as the effect after a medication is discontinued, when the symptoms being treated by that medication return with severity greater than before the medication was first taken. The intent of this analysis was to assess whether ZST taken only when needed (prn) after a middle of the night awakening would result in rebound insomnia on nights when the medication was not taken. The analysis evaluated the sleep characteristics on non-dosing nights and average weekly tablet use.
On nights when medication was not taken, no rebound effects were seen, as determined by total sleep time, sleep latency at the beginning of the night and sleep quality. In the study, 65 percent of the patients did not take medication nightly and there was no evidence of increased utilization of drug over the four week treatment period.
Glenn A. Oclassen, President and Chief Executive Officer of Transcept Pharmaceuticals, commented, "The posters presented by Drs. Roth and Rosenberg reflect the growing awareness among clinicians that middle of the night awakening with difficulty returning to sleep is an important insomnia concern. We are honored to have the opportunity to collaborate with these highly regarded researchers."
SOURCE Transcept Pharmaceuticals, Inc.
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