SouthernWorldwide.com – A new treatment option has become available for individuals suffering from agitation associated with Alzheimer’s disease, as the U.S. Food and Drug Administration (FDA) has approved an expanded use for the drug Auvelity.
This marks the first non-antipsychotic drug treatment specifically approved for agitation in Alzheimer’s patients. Auvelity was initially authorized by the FDA in 2022 for the treatment of major depressive disorder in adults.
Agitation is a prevalent and distressing symptom experienced by many adults with Alzheimer’s disease. This condition is characterized by heightened motor activity, as well as verbal or physical aggression.
The FDA highlighted that agitation can significantly diminish the quality of life for both patients and their caregivers. The agency’s commissioner stated that this approval represents a major step forward in assisting patients and families grappling with a particularly challenging aspect of Alzheimer’s disease.
“With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease,” the commissioner added.
Tracy Beth Hoeg, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research, commented on the approval, noting that Auvelity demonstrated effectiveness in treating agitation in Alzheimer’s disease through two randomized clinical trials.
The first trial, a five-week study, evaluated the drug’s impact by assessing the frequency of agitated behaviors based on caregiver reports. The results indicated that Auvelity, developed by Axsome Therapeutics, was significantly more effective in improving these behaviors.
The second study focused on patients who had initially responded to Auvelity. These participants were then randomly assigned to either continue treatment or switch to a different regimen. The study tracked the duration until agitation symptoms reappeared.
Individuals who continued taking Auvelity experienced significantly longer periods before symptom relapse compared to those who received a placebo.
“This approval now offers an additional option to address one of the most difficult sequelae of the disease, especially as it progresses,” Hoeg stated. “We hope this approval will provide meaningful benefit to patients, their families, and caregivers.”
Auvelity is administered in rapid-onset extended-release tablets. The FDA advised healthcare providers to monitor patients’ blood pressure, screen for a history of bipolar disorder, and check for other medications containing bupropion or dextromethorphan before prescribing Auvelity.
Common side effects associated with the medication include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and excessive sweating, according to the FDA.
The treatment also carries a risk of seizures, with the likelihood increasing proportionally with the dosage. Other potential risks include elevated blood pressure, hypertension, and mania in susceptible individuals.
The drug’s prescribing information also includes a warning about an increased risk of suicidal thoughts in younger adults. The FDA recommended that healthcare providers closely monitor patients for the emergence of such behaviors.
The drug is considered a favorable alternative to antipsychotics in many situations, as it tends to cause less drowsiness and fewer other side effects. It targets two key receptors in the brain—NMDA and sigma-1—which helps to alleviate agitation and depression in older adults with dementia, including those with Alzheimer’s.
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This new option provides a potentially better-tolerated treatment for the heart in elderly patients compared to some other medications.
