Scottsdale 9/13/2012 10:35:00 PM
News / Finance

Transcept Pharmaceuticals (TSPT) Finishes Patient Enrollment in Phase 2 Trial of TO-2061

QualityStocks would like to highlight Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address therapeutic needs in the field of neuroscience. Its principal product is the Intermezzo, a low dose sublingual formulation of zolpidem as a sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep.

In the company’s news yesterday,

Transcept Pharmaceuticals announced that it has completed patient enrollment in its Phase 2 clinical trial evaluating TO-2061 which is added as an adjunctive therapy for patients with obsessive-compulsive order (OCD). These patients have not responded adequately to standard first-line treatment with a currently approved OCD medication. These medications include the selective serotonin re-uptake inhibitors (SSRIs) and the tricyclic agent, clomipramine. There is no current FDA-approved adjunctive therapy for these treatment-resistant patients.

TO-2061 is a low dose formulation of ondansetron, a serotonin subtype 3 (5-HT3) receptor antagonist, which has been approved for the treatment of nausea and vomiting caused by chemotherapy and radiation therapy, and for the prevention of post-surgical nausea and vomiting. Ondansetron has an established history of clinical use as a safe and effective treatment at a typical daily dose of 16-24 milligrams.

TO-2061 is being studied at total daily doses of 1-1.5 milligrams, where two pilot studies have already been done. The Phase 2 study is a double-blind, placebo-controlled trial to evaluate the safety and efficacy of TO-2061 as an adjunct in 168 OCD patients who have not responded to conventional therapy. Transcept plans to announce top-line results of this study sometime in the first quarter of 2013.

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