Cariprazine was approved by the FDA in September and is marketed as VRAYLAR – an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder – in the United States for the treatment of manic or mixed episodes of Bipolar I Disorder and Schizophrenia in adults.
Topline results from the MD-72 trial, conducted in the U.S., indicate that flexible doses of cariprazine did not separate significantly from placebo as an add-on treatment in this trial. In a previously conducted trial (MD-75), flexible doses of cariprazine (2-4 mg) were significantly more effective than placebo as an adjunctive treatment to antidepressant therapy in adults with major depressive disorder (MDD) who failed to adequately respond to antidepressant monotherapy, the update noted. It is not uncommon that clinical trials in MDD fail to show a separation from placebo even with effective drugs, therefore both companies remain committed to developing cariprazine as a potential treatment option for patients suffering from this serious illness and will continue to work on a subsequent Phase 3 trial, the update added.
“We are disappointed with the results of this trial. However, we believe that our plan to move forward with another Phase 3 study in Adjunctive MDD coupled with our previous positive clinical trial would provide the two studies needed for submission. This is an important next step to further develop the cariprazine program,” Chief R&D Officer at Allergan.
Last January, Richter and Allergan announced positive phase 3 trial results for cariprazine in the prevention of relapse of schizophrenia symptoms in adult patients. The companies are planning to submit an efficacy supplement that will provide for the maintenance of efficacy in schizophrenia patients.
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