Labopharm completes enrolment for Phase III clinical study for its once-daily trazodone antidepre...( LAVAL QC Sept. 25 / Labopharm Inc...),Health

LAVAL, QC, Sept. 25 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced that it has completed patient enrolment in its North American Phase III clinical trial for its once-daily formulation of the antidepressant trazodone (study 04ACL3-001). More than 400 patients have been enrolled in this study and the final patient is scheduled for randomization at the end of this week.

"Our proprietary Contramid(R) controlled-release technology applied to trazodone has allowed us to develop a novel approach to treating major unipolar depression that addresses the related conditions of insomnia and agitation while providing the benefit of once-daily administration," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We are excited about the prospects for this novel approach to treating depression and are pleased to have completed enrolment for our Phase III study ahead of schedule. We now expect to have results from the study at the beginning of the second quarter of 2008."

Trazodone is widely used in the treatment of depression due to its efficacy, as well as its side effect profile as a member of the serotonin agonist and serotonin reuptake inhibitor (SARI) class of antidepressants. The use of existing formulations of trazodone, however, is limited by the need for multiple-times daily dosing and trazodone's sedative effect on some patients. Depression is often accompanied by insomnia and agitation. In developing a Contramid-based once-daily formulation of trazodone with a dual matrix delivery system allowing both rapid and sustained drug release, Labopharm is taking advantage of trazodone's sedative effect such that its formulation, when taken prior to going to bed, may address insomnia and agitation, two conditions that are often related to depression.

Study 04ACL3-001 is a randomized, double-blind study which compares the efficacy and safety of Labopharm's once-daily formulation of trazodone
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