Purdue's President and Chief Executive Officer, John H. Stewart commented, "We are excited to be working with Transcept towards the launch of this potential new entry into the prescription sleep aid market. This agreement is part of Purdue's plan to diversify our product portfolio and broaden our commercial focus into therapeutic areas that complement our leadership position in pain management." Mr. Stewart added, "We are confident that prescribers will find Intermezzo((R)) to be a valuable therapeutic option for managing patients with middle-of-the-night sleep disorders that fall within the proposed indication for the product's use."
Intermezzo((R)) (zolpidem tartrate sublingual tablet) has the potential to be the first prescription sleep aid specifically approved for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Intermezzo((R)) is a sublingual low dose formulation of zolpidem, the active agent most commonly prescribed in the United States for the treatment of insomnia. Intermezzo((R)) uses approximately one-quarter to one-third of the dose of active drug contained in currently marketed zolpidem-based sleep aids, in a formulation designed to promote rapid sublingual absorption. Transcept believes that Intermezzo((R)), by combining the reduced zolpidem dose with administration only on those nights when a middle of the night awakening actually occurs, has the potential to reduce unnecessary sedative-hypnotic exposure.
Two Phase 3 clinical studies evaluated 376 patients receiving either Intermezzo((R)) or placebo. In the first study, a sleep laboratory trial using an objective polysomnographic end
|SOURCE Transcept Pharmaceuticals, Inc.; Purdue Pharmaceutical Products L.P.|
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