FDA News

Vraylar receives FDA approval for maintenance schizophrenia treatment

Herbert Meltzer, PhD
Herbert Meltzer

Allergan recently announced that the FDA approved a supplemental New Drug Application for Vraylar for maintenance treatment of schizophrenia.

“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, of Northwestern Feinberg School of Medicine, said in a press release. “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.”

Efficacy of Vraylar (cariprazine, Allergan) for maintenance treatment of schizophrenia was assessed in an up to 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study.

The study included a 20-week open-label phase in which participants received 3, 6 or 9 mg of cariprazine per day. Participants who met stabilization criteria were then randomized to receive 3, 6 or 9 mg of cariprazine per day or placebo for up to 72 weeks or until relapse.

Time to relapse was significantly delayed among participants who received cariprazine, compared with placebo (HR = 0.52; 95% CI, 0.33-0.82).

C. David Nicholson, PhD
C. David Nicholson

Participants who received cariprazine were less likely to relapse, compared with those who received placebo (29.7% vs. 49.5%).

At the end of double-blind treatment, mean symptom worsening indicated by Positive and Negative Syndrome Scale total and subscale scores, Clinical Global Impressions-Severity rating scale, the 16-item Negative Symptom Assessment and the Personal and Social Performance Scale total scores was greater among participants who received placebo, compared with those who received cariprazine.

Researchers did not find new safety concerns.

“The differences in how people with schizophrenia respond to treatment underscores the importance of having additional treatment options,” C. David Nicholson, PhD, chief research and development officer at Allergan, said in the release. “We are pleased that the FDA has recognized the benefits of Vraylar for maintenance treatment of adults with schizophrenia. This approval demonstrates our continued investment in Vraylar, as well as our commitment to developing treatments that address unmet needs facing people living with mental illness.”

Herbert Meltzer, PhD
Herbert Meltzer

Allergan recently announced that the FDA approved a supplemental New Drug Application for Vraylar for maintenance treatment of schizophrenia.

“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, of Northwestern Feinberg School of Medicine, said in a press release. “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.”

Efficacy of Vraylar (cariprazine, Allergan) for maintenance treatment of schizophrenia was assessed in an up to 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study.

The study included a 20-week open-label phase in which participants received 3, 6 or 9 mg of cariprazine per day. Participants who met stabilization criteria were then randomized to receive 3, 6 or 9 mg of cariprazine per day or placebo for up to 72 weeks or until relapse.

Time to relapse was significantly delayed among participants who received cariprazine, compared with placebo (HR = 0.52; 95% CI, 0.33-0.82).

C. David Nicholson, PhD
C. David Nicholson

Participants who received cariprazine were less likely to relapse, compared with those who received placebo (29.7% vs. 49.5%).

At the end of double-blind treatment, mean symptom worsening indicated by Positive and Negative Syndrome Scale total and subscale scores, Clinical Global Impressions-Severity rating scale, the 16-item Negative Symptom Assessment and the Personal and Social Performance Scale total scores was greater among participants who received placebo, compared with those who received cariprazine.

Researchers did not find new safety concerns.

“The differences in how people with schizophrenia respond to treatment underscores the importance of having additional treatment options,” C. David Nicholson, PhD, chief research and development officer at Allergan, said in the release. “We are pleased that the FDA has recognized the benefits of Vraylar for maintenance treatment of adults with schizophrenia. This approval demonstrates our continued investment in Vraylar, as well as our commitment to developing treatments that address unmet needs facing people living with mental illness.”