Allergan, Richter Announce Positive Phase 3 Study Results

Allergan and Gedeon Richter announced positive topline results for a phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder. 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. Both showed a significantly greater improvement than placebo for the change from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale total score.

“These phase 3 data provide further support for cariprazine as a potential treatment for adults with bipolar depression, and adds to the growing clinical profile of this compound in mental health disorders,” said David Nicholson, chief research & development officer at Allergan. “At Allergan, we’re committed to supporting underserved populations with limited treatment options, and look forward to submitting an sNDA for cariprazine as a treatment option for patients suffering from bipolar I depression.”

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). 5.0% of cariprazine treated patients discontinued due to adverse events versus 2.5% of placebo treated patients.