Allergan and Gedeon Richter report positive data for bipolar disorder therapy

Allergan and Gedeon Richter have announced new clinical data showing the effectiveness of cariprazine in the treatment of bipolar I depression.

Positive topline results from a phase III study of cariprazine have demonstrated its safety and efficacy in the treatment of adults with major depressive episodes associated with bipolar I disorder, marking the second positive pivotal trial of the drug in this indication.

Cariprazine was shown to be generally well tolerated, with sedation, somnolence, dizziness, akathisia and nausea cited as the most commonly reported adverse events. It is expected that this data will be used to support future regulatory filings for the drug.

David Nicholson, chief research and development officer at Allergan, said: "This phase III data provides 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."

The compound has already been approved in the US for the acute treatment of adult patients with schizophrenia or manic or mixed episodes associated with bipolar I disorder, and is sold under the brand name Vraylar.

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