Labopharm Inc. (DDSS) announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the FDA.
Labopharm's NDA for its novel trazodone formulation is based on data from five pivotal pharmacokinetic studies and the positive results from its North American Phase III placebo controlled clinical trial, which enrolled more than 400 patients. The Agency advised the Company that one positive Phase III study is required for the formulation to be approved.
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