Transcept Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. One such product in the company's pipeline is TO-2061, a drug to be used in patients with obsessive-compulsive disorder.
The company announced today 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.
For additional information about Transcept Pharmaceuticals and its drug candidates, including TO-2061, please visit the company's website at transcept.com
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