TC 5214 fails second Phase III trial for Major Depressive Disorder

AstraZeneca announced that the second RENAISSANCE Phase III study of TC-5214 for patients with Major Depressive Disorder did not meet its primary end point. The target measure was change in the Montgomery-Asberg Depression Rating Scale total score after eight weeks of treatment with TC-5214 as compared to placebo. TC-5214 was overall well tolerated in RENAISSANCE 2 and showed an adverse event profile generally consistent with prior clinical trials of TC-5214. Analyses of the full data set from the RENAISSANCE 2 are ongoing. These results follow the recent announcement of top-line results of the RENAISSANCE flexible dose trial study 3, which also did not meet its primary endpoint. AstraZeneca will continue with the development of the two remaining fixed dose Phase III RENAISSANCE trials for efficacy and tolerability. Regulatory filing targets will be reviewed following full results of the remaining studies which are expected in the first half of 2012.