Transcept Pharmaceuticals Announces Phase 2 Clinical Trial of TO-2061 for OCD Did Not Meet Primary Endpoint
Transcept Pharmaceuticals (NASDAQ: TSPT) today announced initial top-line results from its Phase 2 clinical trial evaluating the efficacy and safety of TO-2061 (ondansetron oral tablets 0.5 mg and 0.75 mg) in patients with obsessive compulsive disorder (OCD) who had not adequately responded to treatment with approved first-line therapies. The data from the trial showed that TO-2061 did not meet the primary efficacy endpoint to demonstrate an improvement in OCD symptoms versus placebo.
Transcept expects to complete the remaining protocol-specified analyses in early 2013 and will make a determination on any future development of TO-2061 after further review of the data.
"It is disappointing that the Phase 2 trial of TO-2061 did not meet its primary endpoint, in particular for those patients suffering from treatment resistant OCD," said Glenn Oclassen, President and Chief Executive Officer of Transcept. "Once we have reviewed the full data set, we will determine next steps, if any, in the clinical development program for TO-2061 for the adjunctive treatment of OCD."
About the Study Design
The Phase 2 study was a double-blind, placebo-controlled trial to evaluate the safety and efficacy of TO-2061 in 168 OCD patients who had not adequately responded to