FDA Approves Rexulti Label Expansion for Schizophrenia Maintenance Treatment

Lundbeck and Otsuka have received FDA approval to update the label of brexpiprazole (Rexulti) with clinical data supporting the drug's use as a maintenance treatment for schizophrenia in adults.

Lundbeck and Otsuka have received FDA approval to update the label of brexpiprazole (Rexulti) with clinical data supporting the drug’s use as a maintenance treatment for schizophrenia in adults.

The approval was based on data from a long-term, randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years. Following cross-titration from a previous antipsychotic to Rexulti, as well as a 12 -to 36-week, single-blind Rexulti stabilization phase, those who had been stable for 12 weeks on the drug were randomized in a double-blind treatment phase and then given either Rexulti or a placebo.

Impending relapse was determined if individuals showed worsening symptoms (according to changes in their PANSS or CGI-I scores) or were hospitalized for worsening psychotic symptoms, violent behavior, or suicidal behavior. The researchers’ interim analysis concluded that it took a statistically significant longer time for patients treated with Rexulti to relapse, compared with those on the placebo.

“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,” said Christoph U. Correll, MD, professor of psychiatry at the Hofstra Northwell School of Medicine, in a press release.

In clinical trials, the most common adverse effects of Rexulti were akathisia and weight gain in patients with major depressive disorder, and weight increase in patients with schizophrenia.