Bipolar disorder: Pivotal trial of cariprazine
Allergan plc and Gedeon Richter Plc, announced positive topline results for a phase III study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). This is the second positive pivotal trial of cariprazine for this investigational use.
In this study, the primary efficacy objective was met for both Cariprazine 1.5mg and 3mg dose groups (p<0.05). Both showed a significantly greater improvement than placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score. In this study, cariprazine was generally well tolerated. Sedation, somnolence, dizziness, akathisia and nausea were the most commonly reported adverse events (reported with a frequency of 5% or greater and at least twice that of placebo). In this study, 5.0% of cariprazine treated patients discontinued due to adverse events versus 2.5% of placebo treated patients.
Comment: The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in the 2nd half of 2018.
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