FDA Approves Cariprazine for Schizophrenia Maintenance

The US Food and Drug Administration (FDA) has approved cariprazine (VRAYLAR) for maintenance treatment of adults with schizophrenia.

The Allergen product was previously approved for the acute treatment of schizophrenia in adults, as well as the acute treatment of adults with manic or mixed episodes of bipolar I disorder. The supplemental new drug application (sNDA) for cariprazine was approved based on the results of a 72-week, multinational, double-blind, randomized placebo-controlled trial designed to demonstrate the prevention of relapse in adults with schizophrenia.

Within the trial was a subgroup studied for 20 weeks in an open-label phase consisting of patients treated with 3, 6, or 9 mg daily cariprazine. Over the course of the trial, once patients met the criteria for stabilization, they were randomized to either continued treatment with their dose of cariprazine or switched to placebo for with 72 weeks or until a relapse occurred.

"In these patients, Vraylar (cariprazine) has been shown to be effective in the acute treatment of schizophrenia," David Nicholson, PhD, executive VP and the Chief R&D Officer for Allergan, told MD Magazine. "Importantly, once patients are stabilized, continued use of cariprazine has been shown to delay the time to relapse. Additionally, the relapse prevention data has also shown that once stabilized on cariprazine, patients’ rate of relapse are similar for approximately the first 50 days regardless of whether they are taken off of cariprazine or remain on the treatment. In a typical relapse prevention study, patients who are taken off treatment will begin to have higher rates of relapse starting at approximately seven days, when compared to those who remain on treatment."

Results showed that there was a significant delay to relapse time with cariprazine when compared to placebo (hazard ratio [HR] 0.52; 95% CI, 0.33-0.82; P = .0039). Nearly double a number of patients randomized to placebo (49.5%, n = 49) experienced a relapse compared to patients on cariprazine (29.7%, n = 30). The safety profile of cariprazine in the trial was consistent with the profile across previous studies.

“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,” Herbert Meltzer, MD, professor of psychiatry and behavioral sciences at Northwestern Feinberg School of Medicine, said in a statement. “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. 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.”

Schizophrenia impacts roughly 2.4 million adults in the United States, according to the US Department of Health and Human Services. Allergen’s antipsychotic has a recommended dose of 3 to 6 mg per day for bipolar disorder, and 1.5 to 6 mg per day for patients with schizophrenia.

"There remains serious unmet needs in the treatment of schizophrenia," Nicholson said. "The differences in how patients with schizophrenia respond to treatment underscore the importance of having more treatment options available. With its proven efficacy and well-characterized safety profile, cariprazine provides another treatment option for patients and clinicians."

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