Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease

Yesterday, Otsuka Pharmaceutical and Lundbeck LLC announced FDA approval for Rexulti (brexpiprazole) to manage agitation caused by Alzheimer’s disease. With this new indication, Rexulti becomes the first and only FDA-approved treatment option specific for agitation symptoms of the disease.

Alzheimer’s disease is a leading cause of dementia, a progressive brain disease leading to worsening cognitive function, confusion, and varying levels of behavioral and psychological changes.

“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease. ‘Agitation’ can include symptoms ranging from pacing or restlessness to verbal and physical aggression,” Dr. Tiffany Farchione, MD, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a press release.

“[Agitation] symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Farcione stated.

As such, agitation is associated with high costs associated with Alzheimer’s disease, as patients typically require long-term care and behavioral management.

The FDA approved Rexulti for Alzheimer’s-related agitation based on the findings of two clinical trials. In each trial, researchers compared Rexulti with a placebo, comparing changes in the Cohen-Mansfield Agitation Inventory (CMAI), a test to measure a patient’s level of agitation. In the second trial, participants receiving Rexulti 2 mg or 3 mg per day experienced significant improvements in CMAI scores compared to individuals receiving a placebo.

The FDA previously approved Rexulti for use in patients with schizophrenia and as an adjunct treatment for depression. Based on these indications, the retail cost for a one-month supply of Rexulti is up to $1,400, according to the drug manufacturer.

Rexulti is not approved to treat dementia-related psychosis; antipsychotic drugs, including Rexulti, are associated with an increased risk of death in elderly individuals exhibiting dementia-related psychosis. Rexulti carries a black box warning label for this risk. In the drug’s clinical trials, common side effects of Rexulti were headache, trouble sleeping, dizziness, urinary tract infection, and nasopharyngitis.