REXULTI® (brexpiprazole) FDA Approved for Treating Agitation in Alzheimer’s Disease Patients: A New Breakthrough in Neuropsychiatric Symptom Management

Posted on:May 11, 2023
Last Updated: May 11, 2023
Time to read: 2 minutes

Otsuka Pharmaceutical and Lundbeck LLC have announced that the U.S. Food and Drug Administration (FDA) has approved REXULTI® (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer’s disease.

Brexpiprazole – Psychopharmacology | Mechanism of Action | Clinical Application

This approval makes REXULTI the first and only pharmacological treatment approved in the U.S. for this indication.

Agitation is a common neuropsychiatric symptom in Alzheimer’s dementia and can be challenging to manage for caregivers. The submission was based on two Phase 3 studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer’s disease.

REXULTI has not indicated as an as-needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

The submission was based on two Phase 3 (331-12-283 and 331-14-213), 12-week, randomized, double-blind, placebo-controlled fixed-dose studies that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer’s disease based on the Cohen-Mansfield Agitation Inventory (CMAI) total score. The primary endpoint was a change in agitation symptom frequency (CMAI total score) from baseline at Week 12 in both studies.

Overall conclusions regarding efficacy:

  • Statistically significant treatment effects were demonstrated with the BREX 2-mg treatment group in Study 331-12-283 and with the combined BREX 2-mg and 3-mg treatment group in Study 331-14-213
  • Supportive evidence from Study 331-12-284 suggests a numerical improvement with brexpiprazole over placebo among subjects titrated to BREX 2 mg after Week 4, which was consistent with findings observed with Studies 331-12-283 and 331-14-213
  • Consistent numerical improvements across all three major CMAI subscales in each study.
  • Patients who received brexpiprazole had a 31% greater reduction from baseline in the frequency of agitation symptoms compared to those who received a placebo.

Brexpiprazole was well tolerated, with a low incidence of discontinuations and a safety profile consistent with other indications. This approval provides an important treatment option for managing agitation associated with dementia due to Alzheimer’s disease.