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November 29, 2011

FDA Approves Transcept Pharmaceuticals' Intermezzo for Treatment of Midnight Insomnia

The ever changing scenario of the world has transformed the way we live in a comprehensive manner. While on one hand we find the technological marvels available nowadays have made our lives much comfortable than before, at the same time we have to face the adverse effects of these developments as well. The fast paced and hectic lifestyle of today has put us at risk of suffering from a number of disorders, insomnia, or loss of sleep, being one of them.

Transcept Pharmaceuticals, Inc., a pharmaceutical company that aims to develop proprietary products addressing important therapeutic needs in the field of neuroscience, has a product called Intermezzo (zolpidem tartrate sublingual tablet C-IV) which has been approved by the U.S. Food and Drug Administration (FDA) for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. The tablet has not been indicated for the treatment of middle-of-the-night insomnia if the patient has less than four hours of bedtime remaining before the planned time of waking.

At present, Transcept has been carrying out a Phase 2 study of TO-2061, a low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with approved first-line pharmacotherapy.

Millions of adults within the U.S. have been suffering from a peculiar kind of sleeping disorder known as “Middle-Of-The-Night Awakening With Difficulty Falling Back To Sleep.” Intermezzo is the first and only prescription medicine that has been indicated for treatment of this type of insomnia.

Comprising of a bicarbonate-carbonate buffer, Intermezzo has been formulated as a sublingual tablet and gets quickly assimilated in both women and men after intake. Non-elderly patients are recommended to take 1.75 mg of Intermezzo for females and 3.5 mg for men, and the medicine must be taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep. Patients with an age more than 65 years are recommended to take a 1.75 mg dose of the medicine.

The first product developed by Transcept to have been approved by the FDA, Intermezzo will be developed and commercialized in the U.S. market as the result of a collaboration agreement signed between Transcept and Purdue. According to the agreement, Purdue will notify Transcept by December 8, 2011 whether it will proceed with the commercialization of Intermezzo.

In August 2011, Transcept Pharmaceuticals, Inc. announced to host a conference call on August 11 2011 at 4:30 p.m. Eastern Time to discuss its second quarter 2011 financial results. The company also announced to provide a simultaneous webcast of the conference call on the Investors section of its website.

Arvind Arora is a contributing editor for HealthTechZone. To read more of Arvind's articles, please visit his columnist page.

Edited by Rich Steeves
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