The US Food and Drug Administration (FDA) has registered an additional indication for the use of brexpiprazole. The drug will be available for the treatment of agitation/anxiety associated with dementia in Alzheimer's disease. This is the first formulation approved by the FDA for this indication.
FDA
First drug to treat agitation in Alzheimer's patients
Published May 12, 2023 10:52
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Alzheimer's disease is the most common cause of dementia. Patients with dementia often exhibit behavioral and psychological disorders. Agitation (anxiety) is one of the most persistent, complicated, stressful and costly aspects of caring for patients with behavioral and psychological symptoms of dementia.
- Agitation/anxiety is one of the most common and difficult problems in caring for patients with Alzheimer's dementia. Agitation can include symptoms ranging from incessant walking to verbal and physical aggression. These symptoms are the main reason patients are placed in nursing homes. They are also associated with accelerated disease progression, explains Dr. Tiffany Farchione, director of the Division of Psychiatry at the Center for Drug Evaluation and Research, FDA.
The efficacy of brexpiprazole in treating agitation associated with dementia due to Alzheimer's disease was established by two 12-week, randomized, double-blind, placebo-controlled trials. The age of the participants ranged from 51 to 90 years.
In the first study, patients received 1 or 2 mg of brexpiprazole; in the second, they received 2 or 3 mg. The primary efficacy endpoint was improvement in Cohen-Mansfield Agitation Inventory(CMAI) scores at week 12 of treatment. The CMAI is a survey tool that uses information from caregivers to assess (on a scale of 1 to 7) the frequency of specific aggressive behaviors in patients with dementia. In both studies, patients who received 2 mg or 3 mg of the drug showed a statistically significant and clinically meaningful improvement in CMAI scores compared to patients in the placebo group at week 12 of the study.
The recommended initial dosage for the treatment of anxiety associated with dementia due to Alzheimer's disease is 0.5 mg once a day (from day 1 to day 7). Patients should increase the dose from day 8 to day 14 to 1 mg once a day, and from day 15 to 2 mg once a day. The recommended target dose is 2 mg/db. The dose may be increased to the maximum recommended daily dose of 3 mg after at least 14 days, based on clinical response and tolerability.
The most common side effects of taking brexpiprazole in patients with Alzheimer's dementia anxiety were headache, dizziness, urinary tract infections, nasopharyngitis and sleep disturbances (both excessive sleepiness and insomnia).
Source: FDA
