Rexulti(brexpiprazole)

Rexulti (brexpiprazole) is indicated for the treatment of Schizophrenia in adults. The drug's efficacy was evaluated in several studies, demonstrating statistically significant treatment effects. For instance, in Study 331-12-283, a statistically significant treatment effect was observed for the brexpiprazole 2 mg arm versus placebo. Similarly, Study 331-14-213 showed a statistically significant treatment effect for the combined brexpiprazole 2 and 3 mg/day group versus placebo. The primary efficacy endpoint for Phase 3 studies was the mean change from baseline in the Cohen Mansfield Agitation Inventory (CMAI) at Week 12.

Key efficacy findings include a CMAI Total Score change from baseline at Week 12 (LS mean difference vs placebo) of -2.34. The onset of efficacy for brexpiprazole was observed after 4 weeks. Safety data from three 12-week Phase 3 studies indicated 8 deaths (1.2%) in the brexpiprazole arm (655 subjects) compared to 1 death (0.26%) in the placebo arm (388 subjects).

This information is based on an sNDA (Application Number 205422/S-009) submitted on November 10, 2022, with a PDUFA Goal Date of May 10, 2023, and a Review Completion Date of May 9, 2023. The proposed recommended target dosage regimen for AAD is 2 mg/day, with a maximum recommended daily dosage of 3 mg.