The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for brexpiprazole for the treatment of agitation associated with Alzheimer dementia (AAD).

The sNDA is supported by data from two 12-week, randomized, double-blind, placebo-controlled phase 3 studies (Study 331-12-283 [ClinicalTrials.gov Identifier: NCT01862640] and Study 331-14-213 [ClinicaTrials.gov Identifier: NCT03548584]) that evaluated the efficacy and safety of brexpiprazole, an atypical antipsychotic, in patients with AAD. Patients were randomly assigned to receive brexpiprazole or placebo. The primary endpoint for both studies was the change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score at week 12.

In Study 331-12-283, results showed that treatment with brexpiprazole 2mg/day significantly improved symptoms of agitation compared with placebo (P <.05) based on the mean change in CMAI total score from baseline to week 12. A statistically significant improvement was also observed with brexpiprazole 2mg/day and 3mg/day compared with placebo (P <.05) in Study 331-14-213.

The safety of brexpiprazole was consistent with its known profile. Treatment emergent adverse events that occurred in at least 2% of brexpiprazole-treated patients and more than with placebo were insomnia, somnolence, nasopharyngitis, and urinary tract infection.

A Prescription Drug User Fee Act target date of May 10, 2023 has been set for the application. The FDA is expected to hold an advisory committee meeting to discuss the application.

Brexpiprazole is currently available under the brand name Rexulti for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. Rexulti is also indicated for the treatment of schizophrenia in adults and pediatric patients 13 years of age and older.

References

  1. Otsuka and Lundbeck announce FDA acceptance and Priority Review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia. News release. Otsuka and Lundbeck. January 7, 2023. Accessed January 9, 2023. https://www.businesswire.com/news/home/20230107005003/en/Otsuka-and-Lundbeck-Announce-FDA-Acceptance-and-Priority-Review-of-sNDA-for-Brexpiprazole-for-the-Treatment-of-Agitation-Associated-With-Alzheimer%E2%80%99s-Dementia.
  2. Otsuka Pharmaceutical and Lundbeck present positive data from multiple phase 3 studies showing brexpiprazole significantly improved symptoms of agitation in patients with Alzheimer’s dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress. News release. Otsuka. December 1, 2022. Accessed January 9, 2023. https://www.otsuka-us.com/news/otsuka-pharmaceutical-and-lundbeck-present-positive-data-multiple-phase-3-studies-showing.