FDA News

FDA updates Rexulti labeling for schizophrenia maintenance treatment

The FDA approved a labeling update to Rexulti to reflect findings from a longitudinal randomized withdrawal trial assessing maintenance treatment among adults with schizophrenia.

“There are approximately 2.4 million adults in the United States with schizophrenia and 75% of patients experience relapses where their symptoms return or worsen,” Christoph U. Correll, MD, professor of psychiatry at Hofstra Northwell School of Medicine, said in a press release. “These data, as included in the product labeling, confirm the utility of Rexulti in the maintenance treatment of patients with schizophrenia in order to help delay the time to relapse, giving patients and their physicians new data to consider when selecting an antipsychotic.”

Christoph U. Correll, MD
Christoph U. Correll

To determine the safety and efficacy of Rexulti (brexpiprazole, Lundbeck/Otsuka Pharmaceutical Co., Ltd.) as maintenance treatment for schizophrenia, researchers randomly assigned adults who were symptomatically stable on brexpiprazole for 12 weeks to receive brexpiprazole (n = 97) or placebo (n = 105).

Interim analysis indicated participants who received brexpiprazole had statistically significantly longer time to relapse, compared with placebo.

As a result, the trial was terminated early because maintenance efficacy was demonstrated, according to a company press release.

Final analysis indicated a statistically significantly longer time to relapse among participants who received 1 mg or 4 mg per day of brexpiprazole, compared with placebo (HR = 0.292; P < .0001).

The proportion of participants who met criteria for impending relapse was statistically significantly lower among participants who received brexpiprazole.

The FDA approved a labeling update to Rexulti to reflect findings from a longitudinal randomized withdrawal trial assessing maintenance treatment among adults with schizophrenia.

“There are approximately 2.4 million adults in the United States with schizophrenia and 75% of patients experience relapses where their symptoms return or worsen,” Christoph U. Correll, MD, professor of psychiatry at Hofstra Northwell School of Medicine, said in a press release. “These data, as included in the product labeling, confirm the utility of Rexulti in the maintenance treatment of patients with schizophrenia in order to help delay the time to relapse, giving patients and their physicians new data to consider when selecting an antipsychotic.”

Christoph U. Correll, MD
Christoph U. Correll

To determine the safety and efficacy of Rexulti (brexpiprazole, Lundbeck/Otsuka Pharmaceutical Co., Ltd.) as maintenance treatment for schizophrenia, researchers randomly assigned adults who were symptomatically stable on brexpiprazole for 12 weeks to receive brexpiprazole (n = 97) or placebo (n = 105).

Interim analysis indicated participants who received brexpiprazole had statistically significantly longer time to relapse, compared with placebo.

As a result, the trial was terminated early because maintenance efficacy was demonstrated, according to a company press release.

Final analysis indicated a statistically significantly longer time to relapse among participants who received 1 mg or 4 mg per day of brexpiprazole, compared with placebo (HR = 0.292; P < .0001).

The proportion of participants who met criteria for impending relapse was statistically significantly lower among participants who received brexpiprazole.