(By Balaseshan) Transcept Pharmaceuticals Inc. (NASDAQ: TSPT) said a phase-2 clinical trial of TO-2061 as adjunctive therapy for obsessive compulsive disorder did not meet primary endpoint.
The company 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. TO-2061 is an investigational drug designed as an adjunctive treatment for use with approved OCD medications.
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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. 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," said Glenn Oclassen, Chief Executive of Transcept.
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.
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TSPT closed Thursday's regular session at $5.16. The stock has been trading between $4.10 and $12.99 for the past 52 weeks.