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Published on 12/19/2005 in the Prospect News Biotech Daily.

DOV begins second phase 1b trial of triple reuptake inhibitor antidepressant

By Angela McDaniels

Seattle, Dec. 19 - DOV Pharmaceutical Inc. said it has dosed the initial set of subjects in a second phase 1b clinical trial of antidepressant DOV 21,947.

The trial is a double-blind, randomized, placebo-controlled study conducted in 28 normal volunteers. Subjects in the trial will receive single or multiple doses of DOV 21,947 or placebo for one week.

DOV said it expects to complete dosing by the end of the first quarter of 2006 and report the results in the second quarter of 2006.

The clinical trial is designed to determine the upper limit dose to be used in the phase 2 evaluation of efficacy and safety in depressed outpatients, planned to be initiated in the third quarter of 2006, the company said.

A prior phase 1b study in normal volunteers conducted by DOV evaluated the safety and pharmacokinetics of repeat doses of DOV 21,947 and indicated that the drug was well-tolerated, the company said.

DOV 21,947 inhibits the reuptake of the three neurotransmitters most closely linked to depression: serotonin, norepinephrine and dopamine. This is a novel combination of properties in a single antidepressant, the company said.

DOV is a biopharmaceutical company based in Hackensack, N.J., that develops drug candidates for disorders that involve alterations in neuronal processing such as insomnia, pain, anxiety and depression.


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