Date: 2011-12-20
Type of information:
phase: 3
Announcement: results
Company: AstraZeneca (UK)
Product: TC-5214
Action mechanism:
Disease: major depressive disorder (MDD)
Therapeutic area: CNS diseases - Mental diseases
Country:
Trial details:
Latest
news: 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 second of four Phase III efficacy and tolerability studies of the compound as an adjunct therapy to an antidepressant in patients with major depressive disorder who do not respond adequately to initial antidepressant treatment, 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 efficacy and tolerability studies and one long-term safety study. Regulatory filing targets will be reviewed following full results of the remaining studies which are expected in the first half of 2012. A potential New Drug Application filing in the US is planned for the second half of 2012, with an EU Marketing Authorisation Application targeted for 2015.
