FDA Decision on Brexpiprazole for Alzheimer’s Agitation Due in May

Therapy is an antipsychotic approved under the name Rexulti to treat schizophrenia, depression

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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A person sitting at a table experiences agitation.

The U.S. Food and Drug Administration (FDA) will consider brexpiprazole to treat agitation in people with Alzheimer’s disease.

The supplementary new drug application, submitted by developers Otsuka Pharmaceutical and Lundbeck, has been granted priority review by the FDA, shorting its review time from the standard 10 months to six. A decision is expected by May 10.

The FDA has indicated it plans to hold an advisory committee meeting to discuss the application. If approved, brexpiprazole would become the first medication specifically indicated to treat agitation associated with Alzheimer’s dementia in the U.S.

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“This milestone is important in our efforts to bring patients with Alzheimer’s dementia and their caregivers one step closer to having a potential treatment option that may address a major disabling neuropsychiatric symptom of the disease,” said Johan Luthman, executive vice president of Lundbeck Research and Development, in a press release.

Agitation — excessive or inappropriate displays of emotion, like physically or verbally lashing out at people nearby — affects nearly half of people with Alzheimer’s dementia and can be difficult for patients and their loved ones.

Brexpiprazole is an antipsychotic medication approved under the brand name Rexulti to treat schizophrenia and as an add-on treatment for depression in adults. It works by modulating the activity of certain signaling molecules in the brain, particularly dopamine and serotonin, which can help stabilize mood.

“Agitation associated with Alzheimer’s dementia is complex and difficult to navigate for both patients and caregivers,” said John Kraus, MD, PhD, executive vice president and chief medical officer at Otsuka Pharmaceutical Development and Commercialization. “Our commitment to patients is unwavering as we work to provide them and their caregivers with an option to help lessen the symptoms of agitation.”

The application is supported by data from two Phase 3 trials — Study 331-12-283 (NCT01862640) and Study 331-14-213 (NCT03548584) — that collectively enrolled more than 700 people with Alzheimer’s-related agitation.

In both studies, patients were randomly assigned to receive varying doses of brexpiprazole or a placebo for 12 weeks. The main goal was to determine the effect of treatment on a standardized measure of agitation called the Cohen-Mansfield Agitation Inventory (CMAI).

Results from the trials showed brexpiprazole at a daily dose of 2 or 3 mg significantly outperformed a placebo at lessening agitation based on CMAI scores.