FDA Approves First Drug Meant to Ease Alzheimer Disease-Linked Agitation

THURSDAY, May 11, 2023 (HealthDay News) — A medication to treat agitation in patients with Alzheimer disease now has approval from the U.S. Food and Drug Administration.

The FDA gave supplemental approval for Rexulti (brexpiprazole) oral tablets on Thursday. Rexulti is the first FDA-approved treatment for agitation associated with Alzheimer disease. The approval for Rexulti was made under the FDA Fast Track designation, which speeds the review of drugs to treat serious conditions and satisfy an unmet medical need.

The approval followed two 12-week studies. Participants were aged 51 to 90 years old and had a probable diagnosis of Alzheimer dementia, along with the type, frequency, and severity of agitation behaviors that require medication. Patients in the first study received either 1 or 2 mg of Rexulti. In the second study, they received 2 or 3 mg of Rexulti.

Over the 12 weeks, researchers looked for a change from baseline in a patient’s Cohen-Mansfield Agitation Inventory (CMAI) score. Patients who received 2 or 3 mg of Rexulti had statistically significant and clinically meaningful improvements in total CMAI scores compared with patients taking a placebo.

Recommendations call for new patients to take 0.5 mg once daily on days 1 to 7. They should step up to 1 mg daily on days 8 through 14 and then to 2 mg daily starting on day 15. The recommended target dose is 2 mg once daily.

Possible side effects include headache, colds, dizziness, urinary tract infection, and sleep disturbances. Rexulti will continue to carry a Boxed Warning designation for medications in this class. Elderly patients with dementia-related psychosis who are being treated with antipsychotic drugs have an increased risk for death.

Supplemental approval of Rexulti was granted to Otsuka Pharmaceutical Company and Lundbeck.