NEWNow you can listen to Fox News articles!
The US Food and Drug Administration has green-lighted the first non-antipsychotic treatment for agitation in Alzheimer’s disease patients.
The drug, Auverity, was originally approved by the FDA in 2022 to treat adults with major depression. Recently, its use has been extended to agitation associated with dementia.
Agitation is a common and “distressing” symptom in adults with Alzheimer’s, according to the agency. This condition is characterized by excessive motor activity, or verbal or physical abuse.
ALZHEIMER’S SCIENTISTS FIND KEY TO STOPTING BRAIN DECLINE BEFORE SYMPTOMS
The FDA noted that agitation “can have a significant impact on the quality of life of patients and caregivers.”
Auveality was found to be “effective in the treatment of Alzheimer’s disease” in two randomized trials, according to the doctor. (Stock)
In a press release, the FDA commissioner noted that this approval “represents a significant advance in our ability to help patients and families facing one of the most challenging aspects of Alzheimer’s disease.”
“With today’s action, patients and their families are able to access more important treatments for the complications of this devastating disease,” he said.
DRUGS THAT REDUCE THE RISK OF DEMENTIA — AND OTHERS THAT PREVENT IT
Tracy Beth Hoeg, MD, PhD, acting director of the FDA’s Center for Drug Evaluation and Research, also expressed approval, noting that Auveality was found to be “effective in the treatment of Alzheimer’s disease” in two randomized trials.
The first study was a five-week trial of the drug, in which patients were assessed for frequency of agitated behavior based on caregiver reports. The results found that Auveality, made by Axsome Therapeutics in New York City, was “superior” in improving behavior.
The second study looked at patients who responded to Auveality and were randomly assigned to continue treatment or switch, tracking how long it took for anxiety symptoms to return.
Auveality is used in immediate-release tablets. (Stock)
Participants who continued Auverity reported significantly longer times before relapse compared to those who received placebo treatment.
CLICK HERE FOR MORE LIFESTYLES
“[This approval] now represents an additional option to address one of the most difficult consequences of the disease, especially as it progresses,” Hoeg said in a statement. “We hope this approval will provide meaningful benefits to patients, their families and caregivers.”
Auveality is used in immediate-release tablets. The FDA urged healthcare providers to monitor blood pressure, check the medical history of bipolar disorder, and determine whether patients are taking other medications containing bupropion or dextromethorphan before prescribing Auverity.
CLICK HERE TO SUBSCRIBE TO OUR HEALTH PAPER
The most common side effects of the drug include dizziness, stomach upset, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction and uncontrollable sweating, according to the FDA.
The FDA noted that agitation “can have a significant impact on the quality of life of patients and caregivers.” (Stock)
The treatment can also cause seizures, and the risk increases with the dose. Other risks include high blood pressure, high blood pressure and dementia in susceptible patients.
CLICK HERE TO DOWNLOAD THE FOX NEWS PROGRAM
Information prescribing the drug also warns of increased suicidal thoughts in young adults; providers should monitor patients for the emergence of this behavior, the FDA advises.
CALLOUT: “It’s a good decision [over] anti-psychotics in most cases, because they don’t cause the same amount of drowsiness or other side effects.”
Fox News senior medical analyst Dr. Marc Siegel applauded the approval in an interview with Fox News Digital.
The doctor said that the treatment works on two brain targets – NMDA and sigma-1 receptors – helps reduce aging and stress in elderly people with dementia, including Alzheimer’s patients.
TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ
“It’s a good decision [over] anti-psychotics in many cases, because they don’t cause the same drowsiness or other side effects … and they are better tolerated by the heart in the older person,” Siegel said.
