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Labopharm to submit once-daily trazodone

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Labopharm intends to file its once-daily version of the antidepressant trazodone using the 505(b)(2) pathway by the end of 2008, the firm said Feb. 8 after announcing positive Phase III results. Labopharm is touting the formulation's ability to "significantly improve the overall quality of sleep [with] less awakening at night." Labopharm believes that the once-daily option that reduces agitation and improves sleep quality will reduce the need for add-on therapies and be well-positioned in the antidepressant marketplace. Once-daily trazodone met the primary endpoint (HAMD-17) in the 8-week placebo-controlled study of 412 patients with major depression. The dropout rate was 21 percent for placebo and 30.2 percent for trazodone, with 4 percent of those patients discontinuing due to somnolence or sedation...

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