FDA approves Vraylar for schizophrenia, bipolar disorder

The US Food and Drug Administration (FDA) today approved Vraylar (cariprazine) to treat schizophrenia and bipolar disorder.

Schizophrenia is a chronic, severe, and disabling mental disorder whose cause is unknown. Neither Vraylar nor any other drug in this class is approved to treat such patients.

The FDA approval of cariprazine is based on the results of three 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.

Bipolar disorder, sometimes called manic-depression, commonly includes symptoms such as alternating periods of depression and mania, or “highs”, characterized by irritability, restlessness, talking quickly, impulsive behavior and decreased need for sleep, the FDA said. In each of the trials, Vraylar reduced symptoms of schizophrenia compared with placebo. Vraylar also showed efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, meeting the study’s secondary efficacy endpoints for both conditions.

He added that variety in treatment options should be available so that care plans can be modified to suit individual patient’s needs.

All FDA-approved drugs for schizophrenia and bipolar disorder must carry a black box warning indicating an increased risk of death if these drugs are used by older people with dementia-related psychosis, the agency noted. It’s an antagonist of the serotonin 5-HT2B and 5-HT2A receptors, and it also binds to histamine H1 receptors.

Recommended dosing is once a day at 3 to 6 mg for schizophrenia and 1.5 to 6 mg for bipolar disorder.

Gedeon Richter Nyrt., hit by eroding sales in some of its European markets, headed for the biggest gain in five months after US authorities granted approval for an anti-psychotic drug developed jointly with Allergan Plc. The company already sells Viibryd to treat major depressive disorder in adults.