Transcept completes enrollment in TO-2061 Phase 2 trial for obsessive compulsive disorder

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced that it has completed enrollment in its Phase 2 clinical trial evaluating TO-2061 added as adjunctive therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to first-line treatment with an approved OCD medication. The Company plans to announce top-line results of this study in the first quarter of 2013.

OCD affects 1 to 2 percent of the U.S. adult population and can significantly impair the lives of patients and their families. Approximately 40 percent to 60 percent of patients do not respond adequately to standard first-line treatment with currently approved OCD medications, including the selective serotonin re-uptake inhibitors (SSRIs) and the tricyclic agent, clomipramine. There is no FDA-approved adjunctive therapy for these treatment resistant patients.

TO-2061 is an investigational drug designed as an adjunctive treatment for use with approved OCD medications. TO-2061 is a low dose formulation of ondansetron, a serotonin subtype 3 (5-HT3) receptor antagonist, that has been approved for the treatment of nausea and vomiting caused by chemotherapy and radiation therapy, and for the prevention of postsurgical nausea and vomiting. Ondansetron has an established history of clinical use as a safe and effective treatment at a typical daily dose of 16 mg to 24 mg. TO-2061 is being studied at total daily doses of 1 mg to 1.5 mg.