Allergan ($AGN) and Gedeon Richter (BUX:RICHTER) have reported negative data from a Phase III trial of cariprazine in patients with major depressive disorder (MDD). The data continue the turbulent history of cariprazine, which was originally rejected by the FDA in schizophrenia and bipolar disorder before later winning over the regulator.
Budapest, Hungary-based Richter and its partner Allergan are hoping the impact of the negative Phase III MDD data is similarly temporary. The U.S. trial enrolled adults with MDD for whom existing antidepressant monotherapies proved ineffective and randomized them to receive variable daily doses of cariprazine or a placebo. Researchers assessed the efficacy of the regimens using the Montgomery-Asberg Depression Rating Scale, a way to grade the severity of MDD symptoms.
Based on an earlier trial, Allergan and Richter had expected the Phase III study to link cariprazine to an improvement in symptoms. However, the trial failed to detect a significant difference between the performance of the two arms, resulting in the study missing its primary endpoint. That outcome wiped as much as 4% off the approximately $3.5 billion market cap of Richter, although the partners are presenting it as more of a temporary blip than a fatal blow.
“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,” Allergan Chief R&D Officer David Nicholson said in a statement. “This is an important next step to further develop the cariprazine program.”
Whether such optimism is justified will become clearer once Allergan and Richter have data from the other Phase III MDD trial. That study is one of several the companies are running in an attempt to demonstrate that cariprazine can live up to the self-generated hype. Richter, which originally worked on the drug with Forest Laboratories, has touted cariprazine as a $2 billion-a-year drug, although at times in its development there have been doubts about whether it would generate any sales.
Those doubts were wiped aside when cariprazine won FDA approval at the second attempt last year. Since then, the partners have worked to generate data that will support the use of the drug in more indications. In addition to the MDD development strategy, Allergan and Richter are also assessing the efficacy of cariprazine in bipolar depression and predominant negative symptoms of schizophrenia.
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