Three Phase III studies of Brintellix (Lundbeck/Takeda) for Depression meet primary endpoint

New data from four Phase III studies evaluating effectiveness in treating Depression in patients taking Brintellix (vortioxetine), from Lundbeck and Takeda, shows that three of the four pivotal studies met their primary efficacy endpoint as measured by the change from baseline of the Montgomery-Asberg Depression Rating Scale (MADRS) total score. The studies were multicenter, randomized, double-blind, parallel-group trials in adults, to assess improvement in overall symptoms of depression at week 8.

Statistically significant improvements in overall symptoms of depression were demonstrated, as compared to placebo. A fourth study did not meet the primary endpoint. Adverse events reported in more than 5% of the vortioxetine group included nausea, headache, dry mouth and dizziness.

The studies are part of a larger NDA data package that is currently under review by the FDA that includes data from seven positive studies � six short-term studies and one long-term maintenance study. Data will be presented at the 2013 American Psychiatric Association Annual Meeting.