FDA Approves Allergan’s Vraylar for Treatment of Bipolar Disorder


The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application for Vraylar for the expanded treatment of depressive episodes associated with bipolar I disorder in adults.

Vraylar (cariprazine), developed by Hungary-based Gedeon Richter Ltd. and licensed by Allergan, has also been approved in the U.S. for treatment of manic or mixed episodes associated with bipolar I disorder in adults. There are approximately 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy and activity levels. Vraylar has also been approved for the treatment of schizophrenia in adults in the U.S.

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The approval of Vraylar for this condition is based on three trials, RGH-MD-53, RGH-MD-54 and RGH-MD-56, in which cariprazine demonstrated greater improvement than placebo for the change from baseline to week six on the Montgomery Asberg Depression Rating Scale. In all three studies, Allergan said the 1.5 mg dose demonstrated statistical significance over placebo. Additionally, in the RGH-MD-54 trial, the 3 mg dose of Vraylar demonstrated statistical significance over placebo, the company said. Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.

David Nicholson, Allergan’s chief research and development officer, said the FDA approval of Vraylar represents an important milestone in the company’s efforts to help patients and prescribers manage bipolar I disorder. Additionally, Nicholson said the approval reinforces the company’s ongoing focus on mental health.

“We are committed to developing therapies for complex mental health disorders, including Vraylar, which is currently in Phase III clinical trials for the treatment of major depressive disorder,” Nicholson said in a brief statement.

István Greiner, research director of Gedeon Richter Plc, called the approval of Vraylar a “notable achievement in the development process of cariprazine, our flagship product.”

For Allergan, the approval of Vraylar comes on the heels of a failure in major depressive disorder. In March, the company announced that rapastinel, its late-stage adjunctive treatment for major depressive disorder, failed to distinguish itself against placebo. At the time, Nicholson said the failure was a “vivid reminder” of how challenging drug development is, particularly in the field of mental health.

For bipolar patients, about 70% of people with the disorder receive at least one misdiagnosis and consult an average of four doctors over approximately 10 years before being accurately diagnosed, Allergan said. Many patients take multiple medications to treat the symptoms of this condition.

Stephen Stahl, a University of California San Diego professor of psychiatry and lead author of the post hoc analysis for Vraylar, said treating depression, mania and mixed episodes with a single medication is important for patients dealing with these complex illnesses. Stahl said the approval of Vraylar can streamline treatment decisions.

“Treating bipolar disorder can be very difficult because people living with the illness experience a range of depressive and manic symptoms, sometimes both at the same time, and this FDA approval gives healthcare providers a new option to treat the full spectrum of bipolar I disorder symptoms, specifically manic, mixed, and depressive episodes, with just one medication," Stahl said in a statement.

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