Allergan plc and Gedeon Richter Plc said the phase 3 trial of Vraylar for treating major depressive episodes associated with bipolar 1 depression met its main goal.
Results from the RGH-MD-54 study showed that the 1.5- and 3-milligram doses of the treatment, also known as cariprazine, worked better than placebo.
Vraylar was also well tolerated under the study.
Allergan plans to submit a supplemental new drug application to expand Vraylar's indication in the U.S., in the second half of 2018.
Vraylar was discovered and co-developed by Gedeon Richter and is licensed by Allergan in the U.S. and Canada.
Vraylar is already approved as a treatment of adult patients with manic or mixed episodes associated with bipolar 1 disorder as well as for adults with schizophrenia.