The U.S. Food and Drug Administration approved Allergan PLC and Gedeon Richter PLC's Vraylar for treating depressive episodes associated with bipolar 1 disorder in adults.
The approval was based on three pivotal clinical trials called RGH-MD-53, RGH-MD-54 and RGH-MD-56, which all showed that Vraylar, or cariprazine, was better than placebo in alleviating depressive episodes.
Vraylar was previously approved by the U.S. regulator for treating manic or mixed episodes associated with bipolar 1 disorder in adults.
About 11 million adults in the U.S. are living with bipolar disorder, which causes shifts in mood, energy and activity levels, the companies said in a May 28 news release.
Budapest-based Gedeon Richter discovered and is co-developing Vraylar. The drug is licensed by Dublin-based Allergan in the U.S. and Canada.