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 once-daily trazodone group versus the placebo group. Statistical significance was achieved for the primary endpoint (p value of 0.0183) and under additional methods of analysis as specified in the Statistical Analysis Plan (SAP). The overall drop out rate in the study was 25.5%. The drop out rate was 21% in the placebo group and 30.2% in the once-daily trazodone group. The study also demonstrated significantly improved patient sleep patterns in favour of trazodone.
Labopharm plans to file a new drug application for its once-daily formulation of trazodone with the FDA later in 2008. The Agency advised the company that one positive Phase III study is required for the formulation to be approved.
James Howard-Tripp, president and CEO of Labopharm, said: “The positive results of this study not only demonstrate the efficacy and safety of our once-daily formulation, but also the ability of our formulation to significantly improve the overall quality of sleep – there was significantly less awakening at night.”