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 The leading web portal for pharmacy resources, news, education and careers April 20, 2018
Pharmacy Choice - Pharmaceutical News - FDA approves Vraylar in the maintenance treatment of schizophrenia [T-break Tech (Middle East)] - April 20, 2018

Pharmacy News Article

 11/14/17 - FDA approves Vraylar in the maintenance treatment of schizophrenia [T-break Tech (Middle East)]

The U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

Schizophrenia is one of the most challenging mental health disorders to manage particularly due to the complexity of patient symptoms, varying response to treatment and high rates of relapse, said Dr Herbert Meltzer, Professor of Psychiatry and Behavioral Sciences at Northwestern Feinberg School of Medicine. The goal of clinicians is to minimise relapses, which can cause significant personal distress and can often have serious implications for a patients health. The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.

Without maintenance treatment, 60 70 percent of schizophrenia patients relapse within one year. Once a schizophrenia patient reaches the stable or maintenance phase of treatment, it is important for the physician to develop a long-term treatment management plan to minimise relapse risk, monitor, for and reduce the severity of side effects, and address residual symptoms where possible.

The efficacy of Vraylar in the maintenance treatment of schizophrenia was based on an up to 72-week, multinational, double-blind, placebo-controlled, randomised withdrawal study in the prevention of relapse in adult patients with schizophrenia. The study included a 20-week open-label phase where patients with schizophrenia were treated with cariprazine 3, 6 or 9 mg per day. Patients who responded and met the stabilisation criteria during the open-label period were then randomised either to continue their Vraylar dose (3, 6 or 9 mg per day) or be switched to placebo for up to 72 weeks or until a relapse occurred. The primary endpoint was time to relapse during the randomised, double-blind phase.

The study demonstrated that Vraylar significantly delayed the time to relapse compared to placebo (P=0.0010). Relapse occurred in nearly twice as many placebo-treated patients (49.5%, n=49/99) as VRAYLAR-treated (29.7%, n=30/101) patients. The safety results were consistent with the profile observed to-date for VRAYLAR.



(c) 2017 Future Publishing Limited Quay House, The Ambury, Bath BA1 1UA. All rights reserved Provided by SyndiGate Media Inc. (Syndigate.info).

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