FDA approves Richter and Allerganʼs cariprazine

Initiatives

The U.S. Food and Drug Administration (FDA) has approved VRAYLAR™ (cariprazine) capsules produced by Hungarian Gedeon Richter and Dublin-based Allergan, the two firms said in a joint announcement this morning.

VRAYLAR™ (cariprazine) is an atypical antipsychotic, for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treatment of schizophrenia in adults.

“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,” said David Nicholson, Executive Vice President and President of Global R&D brands of Allergan. “This approval reinforces our deep commitment to the mental health community, as we continue to build our robust CNS portfolio.”

Bipolar I disorder and schizophrenia are chronic and disabling mental health disorders, the announcement says. 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, it adds. Schizophrenia is characterized by delusions, hallucinations, disorganized speech and behavior, and other symptoms that cause social or occupational dysfunction, according to the announcement.

“Bipolar I disorder and schizophrenia are serious, chronic and treatable conditions. The symptoms and response to treatment vary from patient to patient making these conditions challenging to manage,” said Gary Sachs, MD, Founding Director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and Associate Professor of Psychiatry at Harvard Medical School.

The announcement noted that the FDA approval of VRAYLAR™ is based on the results of three 3-week controlled trials in adults with manic or mixed episodes of bipolar I disorder and three 6-week placebo-controlled trials in adults with schizophrenia. In these clinical trials involving more than 2,700 adults, VRAYLAR™ demonstrated improvement compared to 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, the announcement said, adding that VRAYLAR™ also demonstrated efficacy as measured by the Clinical Global Impressions-Severity (CGI-S) rating scale, the secondary efficacy endpoints for both conditions.

“This approval is a notable achievement for Gedeon Richter’s discovery platform,” said Erik Bogsch, Managing Director of Gedeon Richter Plc. “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.”

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

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