September 27, 2005

DOV Pharmaceutical has reported the results of a Phase II clinical trial with DOV 216,303, a triple reuptake inhibitor, for the treatment of depression.

The clinical trial was a randomized, multicenter, double-blind, safety, efficacy and tolerability study with 67 patients and compared 50 mg of DOV 216,303 to 20 mg of citalopram, a selective serotonin reuptake inhibitor (SSRI). Both drugs were administered for two weeks to hospitalized patients and outpatients with moderate-severe major depressive disorder. The primary efficacy endpoint was the physician's assessment of depression using the widely recognized Hamilton depression (HAM-D) scale.

Patients who completed two weeks of treatment in both the DOV 216,303 and citalopram groups demonstrated reductions from baseline in the total HAM-D scores. In both groups, the reductions from baseline in the HAM-D scores were greater than 40 percent. This study also confirmed the findings of two previous Phase I trials in normal volunteers that showed that DOV 216,303 was generally well-tolerated, with no serious adverse events occurring.