Alarm As FDA Fast-Tracks First Antipsychotic For Dementia Agitation

In trials, the antipsychotic drug brexpiprazole failed to provide a clinically meaningful benefit and increased the risk of death.

The US Food and Drug Administration has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia.

Professor Lon Schneider at the Keck School of Medicine of the University of Southern California noted that the brexpiprazole outcomes mirrored the results from earlier trials of antipsychotics in Alzheimer's patients, yet none of these other antipsychotics has been approved for treating behavioural symptoms in elderly patients with dementia.

Schneider says the FDA has a "Lower standard of approval" today than it did 20 years ago, a theme echoed by Zeldes, who said: "We are very disappointed that the FDA approved this additional label indication for brexpiprazole on such weak data. The FDA has set a dangerous precedent about the data it may require for future drug approvals for this vulnerable patient group."

The chair of the advisory committee, Rajesh Narendran, did not respond to multiple requests for an interview to answer questions raised by this approval, while a spokesperson for the FDA's Center for Drug Evaluation and Research stated that "Due to conflicting schedules and competing priorities," the FDA would be unable to respond.

Erick Turner, a former FDA reviewer and professor of psychiatry at Oregon Health & Science University, said that clinicians' responses to the approval will likely vary according to their current beliefs about prescribing antipsychotics to Alzheimer's patients.

Notes for editorsInvestigation: How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death Doi:10.

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