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# Panel Backs Rexulti for Alzheimer’s Agitation
- URL: https://www.fdaweb.com/panel-backs-rexulti-for-alzheimers-agitation/
- Published: 2023-04-17T12:00:00.000Z
- Updated: 2026-09-14T18:26:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154228

A joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee 4/14 voted 9 to 1 that an Otsuka Pharmaceutical and Lundbeck a sNDA for Rexulti (brexpriprazole) provided sufficient data to allow identification of a population in whom the benefits of treating agitation associated with Alzheimer’s dementia outweigh the drug’s risks. The atypical antipsychotic is already indicated to treat schizophrenia and major depressive disorder.

An FDA [briefing paper](https://www.fda.gov/media/167066/download?ref=fdaweb.com) distributed in advance of the meeting said Rexulti was found in two Phase 3 studies to reduce agitation over 12 weeks. The medical reviewers said agitation is “one of the most common and challenging aspects” of dealing with Alzheimer’s patients and there currently are no FDA-approved drugs for this particular indication. The reviewers also found that Rexulti demonstrated a statistically significant treatment effect with two different dosing regimens across the two Phase 3 trials. A third trial failed to reach its primary endpoint but showed a “nominally significant” effect compared with placebo, the reviewers said.

In voting yes, Indiana University School of Medicine neurology professor **Liana G. Apostolova** said the data showed a statistical significance and a clinically meaningful therapeutic effect. University of Pittsburgh statistics professor **Satish Iyengar** also voted yes and said the studies were well done and the analysis was “quite convincing. Generally speaking, I'm always a little bit leery of secondary analyses, … but in this particular case, I think what people know already from their experience matches the data.” And University of Ottawa psychiatry professor **Jess G. Fiedorowicz** said that while voting yes, he had concerns with the confidence intervals of the safety data, “but we do have data from outside of these studies as well while we wait for additional studies in this population that can be used. And I felt pretty heavily that the context of the clinical case needs to be considered in weighing the risks and benefits.”

The lone negative vote came from consumer representative and co-founder of Woodymatters **Kim O. Witczak**, who said the data did not demonstrate that the benefits outweighed the dangers because Rexulti is an antipsychotic. She warned FDA to be watchful when the drug is advertised to consumers/health professionals, suggesting the claims could be misleading. However, she agreed there is an unmet need and “I hope I'm proven wrong in time, but with this limited amount (of data) I'm not willing to vote yes for this product.”