The FDA will hold a joint meeting of its expert advisors to determine whether the drug Rexulti (brexpiprazole) is appropriate for use in treating agitation associated with Alzheimer’s disease dementia, the agency announced Monday, April 10.
Rexulti currently is approved for use alongside antidepressants in treating major depressive disorder in adults, and for treating schizophrenia in adults and certain pediatric patients. The new application, proposed by makers Otsuka Pharmaceutical Company and Lundbeck, was granted priority review status in January. The FDA meeting will take place April 14.
The drugmakers submitted data from two phase 3 clinical trials to support the newly proposed application. Results showed that treatment with Rexulti at 2mg/day significantly improved symptoms of agitation by week 12 when compared with placebo. Treatment with 3mg/day also was effective, according to a report by Medical Professionals’ Reference.
Safety was similar to the drug’s known profile, the reference also noted. Adverse events occurred in at least 2% of patients treated with Rexulti, including insomnia, somnolence, nasopharyngitis and urinary tract infection.
The advisory committees will review public comments received on or before April 3, 2023. The FDA said that it will take any comments received after that date into consideration as well.
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