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Vraylar Secures FDA Approval to Treat Bipolar I Disorder and Schizophrenia

Clinical trials involving more than 2,700 adults demonstrated improvement

The FDA has approved cariprazine capsules (Vraylar, Allergan/Gedeon Richter), a second-generation antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.

Bipolar I disorder, also known as manic-depressive illness, is a disorder of the brain that is characterized by fluctuations in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Schizophrenia is characterized by delusions, hallucinations, disorganized speech and behavior, and other symptoms that cause social or occupational dysfunction. Both mental health disorders are chronic and disabling.

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.

In these clinical trials, which involved more than 2,700 adults, cariprazine demonstrated improvement compared with placebo as measured by Young Mania Rating Scale (YMRS) total scores in patients with bipolar mania and by Positive and Negative Syndrome Scale (PANSS) total scores in patients with schizophrenia. Cariprazine also demonstrated efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, the secondary efficacy endpoints for both conditions.

The most commonly reported adverse reactions (incidence of at least 5% and at least twice the rate of placebo) in bipolar mania were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness, while those in schizophrenia were extrapyramidal symptoms and akathisia.

Source: Allergan; September 17, 2015.

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