The FDA approved Rexulti (brexpiprazole) oral tablets are supplementary approval for the treatment of agitation associated with dementia caused by Alzheimer’s disease. This is the first therapy option for this indication that has FDA Approved.
Dementia
Dementia is a severe and incapacitating neurological illness marked by gradual impairment in one or more cognitive domains of the brain. Dementia can significantly affect a person’s capacity to operate independently. Many patients with dementia require long-term in-home or residential care. The most prevalent cause of dementia is Alzheimer’s disease. Alzheimer’s disease is an incurable, degenerative brain ailment that affects over 6.5 million Americans. Agitation is a costly aspect of care for patients with dementia, leading to behavioural and psychological disturbances.
Effectiveness of Rexulti
Rexulti’s effectiveness in treating dementia was determined through two studies. Patients are required to have a probable diagnosis of Alzheimer’s dementia, score 5–22 on the Mini-Mental State Examination, and exhibit the type, frequency, and severity of agitation behaviours. Patients received 1 or 2 mg of Rexulti in two studies; the primary efficacy endpoint was a change in CMAI score at week 12. The CMAI is a survey tool that uses caregiver feedback to score the frequency of specific agitative behaviours in dementia patients on a scale of 1 to 7. At week 12, individuals receiving 2 mg or 3 mg of Rexulti demonstrated statistically significant and clinically relevant improvements in overall CMAI scores compared to those in the placebo group in both studies.
The recommended starting dose for the treatment of agitation associated with Alzheimer’s disease dementia is 0.5 mg administered once a day on days 1 to 7. Patients should increase dosage daily up to 3 mg after 14 days, based on clinical response and tolerability.
Headache, dizziness, urinary tract infection, nasopharyngitis, and sleep difficulties (both somnolence and insomnia) are the most prevalent side effects among individuals with agitation linked with dementia caused by Alzheimer’s disease. Rexulti will retain a boxed warning for antipsychotic drugs in elderly patients.
Otsuka Pharmaceutical Company Ltd. and Lundbeck Inc. received Fast Track status for Rexulti, a medication to treat severe disorders, to bring key new medications to patients sooner.
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Source: FDA.gov
