Disappointing results in cariprazine study announced
The MD-72 trial testing cariprazine as an adjunctive medication for patients suffering from major depressive disorder (MDD) showed no significant difference from the placebo. This is in contrast to the previous trial, MD-75, which showed positive results using flexible doses of cariprazine as an adjunctive treatment. Both studies were testing cariprazine as part of an antidepressant therapy for MDD patients who did not respond well to antidepressant monotherapies.
"We are disappointed with the results of this trial," Allergan Chief R&D Officer David Nicholson said. "However, we believe that our plan to move forward with another Phase III 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."
Cariprazine, under the brand name Vraylar, is already approved for treatment of adults with manic or mixed episodes of bipolar I disorder and schizophrenia. Phase III trials testing cariprazine for preventing schizophrenia relapses and predominant negative symptoms (PNS) of schizophrenia have shown positive results. PNS has no approved treatments at this time.
In addition, patient enrollment for the Phase III trial evaluating cariprazine in treating bipolar depression has begun. The Phase 2b trial showed positive results for the participants in the study.