Key Takeaways

The Food and Drug Administration (FDA) last weekapprovedRexulti (brexpiprazole) for treating agitation in Alzheimer’s patients. This is the first-ever treatment option for dementia-associated agitation.

Initially approved in 2015 for depression and schizophrenia, Rexulti was shown to improve agitation symptoms, including pacing, restlessness, as well as verbal and physical aggression.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said ina press release.

Agitation is one of the conditions that often results in families no longer being able to care for the patient at home and having to place the patient in long-term care facilities, according toBruce Albala, PhD, a professor of environmental and occupational health at the University of California, Irvine who has conducted extensive research on dementia.

“The displacement of the patient from their family and their familiar home environment results in yet more disruption for the patient, who will often be fearful and more confused when confronted with new living arrangements and unfamiliar people,” Albala told Verywell.

About half of people with dementia due to Alzheimer’s experience some level of agitation, usually during the middle stage of the disease, Albala said. It could be due to worsening cognition or underlying biological causes from the increasing degeneration of various regions of their brain.

Why Is the FDA Approval of a New Alzheimer’s Drug So Controversial?

How Effective and Safe Is Rexulti?

Rexulti was originally approved as an atypical antipsychotic that could be used as an add-on to antidepressants to treat major depressive disorders and schizophrenia.

The approved prescribing information was changed in 2021 to include a box warning of increased mortality in elderly patients treated with other atypical antipsychotic drugs. Most of the deaths in elderly patients were attributed to cardiovascular causes or infections, Albala said.

In the most recent study investigating the use of this drug for the treatment of patients with agitation, the participants were between the ages of 55 and 90 years old, with an average age of approximately 74. In the two groups of people who received the medication—the first group received 1 mg and the second received 2 mg—researchers reported two deaths in the first group and one death in the second. There were no deaths in the placebo group.

The most recent study results also found that 8%, 9.3%, and 5.2% of each group experienced severe side effects, respectively (1 mg, 2 mg, and placebo), while side effects that weren’t serious impacted 19.7%, 30.7%, and 21.5% of each group, respectively.

“It is reported that this pattern of side effects is consistent with what has been seen for this drug since it was first approved in 2015,” Albala said. “It appears as if the safety and efficacy data was sufficiently convincing for the FDA to grant approval for this new disease indication.”

However, the trial had a very limited representation of minority groups. “In fact, 96.3% of the patients in the recently completed phase III study were identified as White with only 2.8% being Black or African American and 0.9% being Asian,” Albala said. “Clearly, more data is needed to know how well such a medication treatment will work in these non-White populations.”

Is Lecanemab a Game-Changing Alzheimer’s Drug? It May Depend On the Stage of Dementia

How Much Does Rexulti Cost?

Sadly, this drug doesn’t currently come cheap. Albala said the current average pricing for the branded drug is about $1,400 per month without insurance or various discounts.

But a number of pharmaceutical companies have received FDA approval in the last few months to produce the generic form of brexpiprazole in the same dose strengths as Rexulti, he said. When more generic versions of the drug become available, he added, they could lower prices for everyone.

Dementia Support Groups

What This Means For YouRexulti, an existing medication that treats severe depression and schizophrenia, is now FDA-approved to treat agitation in Alzheimer’s patients with dementia.

What This Means For You

Rexulti, an existing medication that treats severe depression and schizophrenia, is now FDA-approved to treat agitation in Alzheimer’s patients with dementia.

2 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Grossberg GT, Kohegyi E, Mergel V, et al.Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer’s dementia: two 12-week, randomized, double-blind, placebo-controlled trials.Am J Geriatr Psychiatry. 2020;28(4):383-400. doi:10.1016/j.jagp.2019.09.009National Library of Medicine.A phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of brexpiprazole in the treatment of Alzheimer’s agitation.Additional ReadingFood and Drug Administration.Rexulti (brexpiprazole) tablets, for oral use[drug label].

2 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Grossberg GT, Kohegyi E, Mergel V, et al.Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer’s dementia: two 12-week, randomized, double-blind, placebo-controlled trials.Am J Geriatr Psychiatry. 2020;28(4):383-400. doi:10.1016/j.jagp.2019.09.009National Library of Medicine.A phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of brexpiprazole in the treatment of Alzheimer’s agitation.Additional ReadingFood and Drug Administration.Rexulti (brexpiprazole) tablets, for oral use[drug label].

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Grossberg GT, Kohegyi E, Mergel V, et al.Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer’s dementia: two 12-week, randomized, double-blind, placebo-controlled trials.Am J Geriatr Psychiatry. 2020;28(4):383-400. doi:10.1016/j.jagp.2019.09.009National Library of Medicine.A phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of brexpiprazole in the treatment of Alzheimer’s agitation.

Grossberg GT, Kohegyi E, Mergel V, et al.Efficacy and safety of brexpiprazole for the treatment of agitation in Alzheimer’s dementia: two 12-week, randomized, double-blind, placebo-controlled trials.Am J Geriatr Psychiatry. 2020;28(4):383-400. doi:10.1016/j.jagp.2019.09.009

National Library of Medicine.A phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of brexpiprazole in the treatment of Alzheimer’s agitation.

Food and Drug Administration.Rexulti (brexpiprazole) tablets, for oral use[drug label].

Meet Our Medical Expert Board

Share Feedback

Was this page helpful?Thanks for your feedback!What is your feedback?OtherHelpfulReport an ErrorSubmit

Was this page helpful?

Thanks for your feedback!

What is your feedback?OtherHelpfulReport an ErrorSubmit

What is your feedback?