Allergan plc and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for VRAYLAR (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. VRAYLAR is also approved in the U.S. to treat manic or mixed episodes associated with bipolar I disorder in adults. There are nearly 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels.
“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 FDAapproval 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,” said Dr. Stephen Stahl, Professor of Psychiatry at the University of California San Diego and lead author of the post hoc analysis, Cariprazine Efficacy in Patients with Bipolar Depression and Concurrent Manic Symptoms. “Treating depression, mania and mixed episodes with a single medication is important for people living with, and healthcare providers treating, this complex illness. This approval can streamline a treatment decision while helping to stabilize the disorder.”
Seventy percent of people living with bipolar disorder receive at least one misdiagnosis and consult an average of four doctors over approximately 10 years before being accurately diagnosed. Many patients take multiple medications to treat the symptoms of this condition.
The FDA approval for the expanded indication of VRAYLAR is based on three pivotal trials, including 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 (MADRS) total score. In all three studies, the VRAYLAR 1.5 mg dose demonstrated statistical significance over placebo; additionally, in RGH-MD-54, the VRAYLAR 3 mg dose demonstrated statistical significance over placebo. Common adverse events reported in the pivotal trials were nausea, akathisia, restlessness, and extrapyramidal symptoms.
“This approval represents an important milestone in our efforts to help patients and prescribing healthcare providers effectively manage bipolar I disorder and demonstrates our ongoing focus on mental health,” said David Nicholson, Chief Research & Development Officer at Allergan. “We are committed to developing therapies for complex mental health disorders, including VRAYLAR, which is currently in Phase 3 clinical trials for the treatment of major depressive disorder.”
“This approval is considered a notable achievement in the development process of cariprazine, our flagship product,” said Dr. István Greiner, Research Director of Gedeon Richter Plc. “We are pleased that more and more patient groups suffering from psychiatric disorders will get access to cariprazine as a treatment option.”