FDA Accepts sNDA for Rexulti for Alzheimer’s Agitation


The agency has assigned a Prescription Drug User Fee Act target action date of May 10, 2023, and plans to hold an advisory Committee

The FDA has accepted a supplemental new drug application (sNDA) for Rexulti (brexpiprazole) for use in the treatment of agitation associated with Alzheimer’s dementia (AAD). The FDA has assigned the application priority review and a Prescription Drug User Fee Act (PDUFA) target action date of May 10, 2023. The agency also indicated it is planning to hold a Psychopharmacologic Drug Advisory Committee meeting to discuss the application.

Agitation is a common symptom of Alzheimer’s dementia, reported in about 45% of patients.

Rexulti was discovered by Otsuka Pharmaceutical Company and is being co-developed by Otsuka and Lundbeck. It was approved in the United States on July 10, 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment for schizophrenia in adults.

John Kraus, M.D., Ph.D.

John Kraus, M.D., Ph.D.

“Agitation associated with Alzheimer’s dementia is complex and difficult to navigate for both patients and caregivers,” John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, said in a press release. “New treatments in this area are desperately needed. 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 submission for agitation associated with Alzheimer’s dementia is based on data from two positive clinical phase 3 studies that investigated the treatment of brexpiprazole in patients with agitation associated with Alzheimer’s dementia. Results were released at the Clinical Trials for Alzheimer’s Disease (CTAD) Congress in San Francisco.

These studies showed that Rexulti 2 mg or 3 mg doses significantly improved symptoms of agitation in patients with Alzheimer’s dementia compared with placebo. The primary endpoint across the studies was improvement from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score, which is used to measure the types and frequency of agitated behaviors.

A key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression-Severity (CGI-S) score related to agitation. The CGI-S is a scale that measures severity of illness.

Rexulti also demonstrated a favorable safety and tolerability profile. The most common adverse events were asthenia (extreme, chronic weakness and fatigue), diarrhea, somnolence, dizziness, urinary tract infections and nasopharyngitis occurred. In addition, adverse events such as falls, akathisia, and extrapyramidal disorder occurred at a rate of less than 2% in the patients treated with Rexulti. Discontinuations due to adverse events occurred in 5.3% of patients treated with Rexulti and 4.3% of patients receiving placebo.

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