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Labopharm Inc. (DDSS) has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada for its novel formulation of the antidepressant trazodone. Labopharm's NDS is based on data from five pivotal pharmacokinetic studies and the positive results from a North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more than 400 patients.
The eight-week randomized, double-blind, two-arm, multi-centre Phase III study in patients with major unipolar depressive disorder demonstrated the efficacy of Labopharm's formulation as a treatment for depression, as well as its positive effect on quality of sleep. The primary efficacy endpoint of the study was to compare the change in the Hamilton Rating Scale for Depression (HAMD-17) total score from baseline to the end of the study in the trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.012). The majority of the secondary efficacy end points, including the HAMD-17 depressed mood item, the Clinical Global Impressions Severity (CGI-S) scale, the Montgomery Asberg Depression Rating Scale (MADRS) total score and a Responder's Analysis showed statistical significance in favor of the group administered Labopharm's trazodone. In addition, patients on Labopharm's trazodone demonstrated significant improvements versus placebo in all three quality of sleep end points, with an improvement by the first week of therapy in "overall quality of sleep" and "awakening during the night". The incidence of agitation, weight gain and sexual dysfunction in patients administered Labopharm's trazodone was no different from placebo.
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