Allergan and Gedeon Richter’s Vraylar posts strong Phase 3 data in bipolar depression

pharmafile | December 19, 2017 | News story | Manufacturing and Production, Research and Development Allergan, Gedeon Richter, Vraylar, bipolar, bipolar depression, pharma 

Vraylar (cariprazine), a drug developed as part of a partnership between Allergan and Gedeon Richter, has demonstrated strong results at Phase 3 in the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression), it has emerged.

The drug met its primary endpoints in both 1.5mg and 3mg dose groups, showing a “significantly greater improvement” than placebo from baseline to week 6 on the Montgomery-Asberg Depression Rating Scale (MARS) total score.

Vraylar has already secured approval for the treatment of manic or mixed episodes of bipolar disorder and schizophrenia in adult patients, but the new data could bring the therapy one step closer to securing an expanded indication.  

“These phase III 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. “Bipolar depression is a serious and impairing condition of bipolar I disorder. 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.”

Gary Sachs, Associate Clinical Professor of Psychiatry at Harvard Medical School, also remarked: “There are a limited number of products approved to treat bipolar depression and even fewer products that have been studied and approved to treat the full spectrum of bipolar disorder, from mania through depression. Having another product proven to treat the full range of bipolar disorder would be a welcome addition to the treatment options currently available to the psychiatry community and patients.”

Matt Fellows

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