The U.S. Food and Drug Administration (FDA) recently approved VRAYLAR (cariprazine) capsules, an atypical antipsychotic intended for acute treatment of manic or mixed episodes stemming from bipolar I disorder and general treatment of schizophrenia in adults, Allergan Plc and Gedeon Richter Plc announced.
"We are pleased with the FDA approval of VRAYLAR, which represents an important new treatment option for adults living with bipolar I disorder and schizophrenia to help address the unmet medical needs of people with these complex conditions," Executive Vice President and President of Global R&D brands of Allergan David Nicholson said. "This approval reinforces our deep commitment to the mental health community, as we continue to build our robust CNS portfolio."
Both bipolar I disorder and schizophrenia are life -changing mental health disorders that are chronic and disabling for the patients. The FDA’s approval of VRAYLAR was based on results shown in three separate three-week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three six-week placebo-controlled trials in adults with schizophrenia.
"This approval is a notable achievement for Gedeon Richter's discovery platform," Managing Director of Richter Gedeon Plc. Erik Bogsch said. "Despite the variety of treatments available for the millions living with bipolar I disorder and schizophrenia, unmet needs remain and we are proud to offer an additional option to help patients manage their symptoms."
Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential.
