The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “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.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.