Vraylar Now Approved for Full Spectrum of Bipolar I Disorder Symptoms

Yesterday the Food and Drug Administration (FDA) approved Vraylar (cariprazine) for the treatment of depressive episodes in adults with bipolar I disorder. This expanded indication means Vraylar, a dopamine and serotonin partial agonist, is now approved to treat depressive, manic, and mixed episodes of bipolar I disorder. Vraylar, which is manufactured by Allergan, is also approved for the treatment of schizophrenia in adults.The drug ’s expanded indication is based on results from three clinical trials (RGH-MD-53,RGH-MD-54, andRGH-MD-56), which evaluated Vraylar once daily versus placebo in adults with bipolar depression. The primary outcome was change in the Montgomery- Åsberg Depression Rating Scale (MADRS) after six weeks of treatment.For the three Vraylar dosages studied, the trials found that patients treated with 1.5 mg/day experienced significant improvements in their MADRS score versus placebo. One trial confirmed similar significant findings for the 3 mg daily dose.“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 health care providers a new option to treat the full spectrum of bipolar I disorder symptoms … with just one medication,” Stephen Stahl, M.D., Ph.D., a professor of psychiatry at the University of California, San Diego, said in apress release from Allergan.The most commonly reported adverse events ...
Source: Psychiatr News - Category: Psychiatry Tags: Allergan bipolar depression bipolar disorder cariprazine depressive episode Stephen Stahl Vraylar Source Type: research