FDA fast-tracks brexpiprazole for dementia
FDA fast-tracks brexpiprazole for dementia
FDA Approves Brexpiprazole for Treating Agitation in Dementia: A Comprehensive Analysis
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The FDA has recently granted fast-track approval for brexpiprazole, an antipsychotic drug, to treat agitation in elderly patients with dementia. While this news has been met with support from advocacy groups like the Alzheimer’s Association, there are concerns regarding the drug’s efficacy and safety.
Investigative journalist Robert Whitiker, in a feature published in the BMJ, highlighted several key issues with the FDA’s decision to fast-track brexpiprazole. He pointed out that the medication produced clinically insignificant improvements in clinical trials and increased the risk of death by four times compared to a placebo.
In light of these concerns, Medical News Today reached out to experts in the field to gain a deeper understanding of brexpiprazole and the FDA’s decision.
Brexpiprazole’s FDA Approval
MNT spoke with an FDA spokesperson to inquire about the fast-track approval of brexpiprazole. The spokesperson explained that the drug was fast-tracked to address an unmet medical need and is the first FDA-approved medication for treating dementia-related agitation.
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The FDA’s decision was based on discussions held during an advisory committee meeting, which included outside experts. The spokesperson emphasized that an overwhelming majority of committee members agreed with the FDA’s conclusion that brexpiprazole is effective and could benefit patients with agitation due to Alzheimer’s disease.
Dr. J. Wes Ulm, a bioinformatic scientific resource analyst and biomedical data specialist at the National Institutes of Health, expressed his thoughts on the news. He highlighted the shortage of effective options for managing dementia and the persistence of agitation despite various forms of support and treatments. Dr. Ulm emphasized the need for drugs that can alleviate agitation, especially with the increasing prevalence of dementia among the Baby Boomer generation.
Assessing the Risk-Benefit of Brexpiprazole
MNT also discussed the safety of prescribing brexpiprazole for patients with dementia based on the clinical trial results. Dr. Ulm explained that the decision presents a complex risk-benefit calculation for clinicians and caregivers. Factors such as the nature of the dementia, patients’ general health, quality and availability of care, and the care setting all play a role in determining the potential benefits of brexpiprazole.
Dr. Ulm stated, “When agitation becomes persistent enough to sharply limit the quality of life and interfere with care, and when other options offer little improvement, then antipsychotics may become a viable modality to consider.”
The Alzheimer’s Association acknowledged the importance of non-drug approaches for managing behavioral symptoms of Alzheimer’s but recognized that medications may be necessary in cases where non-drug approaches are ineffective and there is a risk of harm to the patient or others.
Dr. Nicole Purcell, the Alzheimer’s Association senior director of clinical practice, stated, “People living with moderate and severe Alzheimer’s and other dementia need and deserve treatment that improves the quality of their life, including effective treatments for behavioral and psychiatric symptoms associated with dementia.”
Minimizing Risks Associated with Brexpiprazole
MNT sought advice from experts on how to minimize the risks associated with brexpiprazole. Dr. James Giordano, a professor of neurology, biochemistry, and clinical ethics at Georgetown University Medical Center, suggested that the drug may be most beneficial for patients with mild dementia who exhibit agitative features and are at lower risk for adverse side effects.
Dr. Giordano emphasized the importance of using the lowest effective dose for the shortest duration possible to reduce risks. Dr. David Merrill, a geriatric psychiatrist and director of the Pacific Neuroscience Institute’s Pacific Brain Health Center, highlighted the potential use cases for brexpiprazole in preventing dangerous behaviors and avoiding placement in locked memory care units.
He also stressed the importance of using the medication for the shortest duration necessary to minimize associated risks.
Personalized Dementia Treatment with Brexpiprazole
Dr. Giordano emphasized the need for a personalized precision medicine approach when developing a treatment regimen for dementia. He highlighted that not all therapeutic interventions have the same effectiveness and effects, and it is crucial to evaluate each patient’s unique presentation and characteristics.
While antipsychotics, including brexpiprazole, can effectively reduce certain symptoms in some dementia patients, Dr. Giordano suggested considering other interventions and emerging neurotechnologies to maximize therapeutic benefits and minimize potential side effects.
In conclusion, the FDA’s fast-track approval of brexpiprazole for treating agitation in dementia has sparked both support and skepticism. While the drug offers a potential solution for managing agitation in elderly patients with dementia, concerns remain regarding its efficacy and safety. Clinicians and caregivers must carefully weigh the risks and benefits of brexpiprazole, considering individual patient factors and exploring a range of treatment options to provide personalized care for those with dementia.
