FDA Approves First Non-Antipsychotic Treatment for Alzheimer’s Agitation
The U.S. Food and Drug Administration has approved a groundbreaking non-antipsychotic medication to treat agitation in individuals with Alzheimer’s disease.
Known as Overity, the drug was initially sanctioned by the FDA in 2022 for treating adults suffering from major depressive disorder. Its recent approval expands its use to address agitation linked to dementia.
The FDA describes agitation as a “distressing” symptom frequently seen in those with Alzheimer’s, marked by excessive physical movement or aggressive verbal or physical behavior.
According to FDA officials, agitation can “significantly impact the quality of life of patients and caregivers.” This acknowledgment underscores the importance of managing such symptoms.
In a press release, the FDA Commissioner remarked that the approval of Overity is a vital advance in helping patients and their families navigate one of the most challenging features of Alzheimer’s disease. He emphasized that this decision would open doors to additional crucial treatments for complications arising from this devastating condition.
Dr. Tracey Beth Hogue, acting director of the FDA’s Center for Drug Evaluation and Research, noted that two randomized trials demonstrated Overity’s effectiveness in treating agitation associated with Alzheimer’s.
The first study lasted five weeks, during which the frequency of agitated behaviors was evaluated based on caregiver reports. Results indicated that Overity, produced by Axum Therapeutics in New York City, showed “significantly superior” outcomes in improving behavior.
In the second trial, patients responding positively to Overity were randomly assigned to either continue the treatment or switch to a placebo, with researchers monitoring the duration until agitation symptoms returned.
Participants who continued with Overity experienced a notably longer period before their agitation resurfaced compared to those on a placebo.
Dr. Hogue expressed hope that this approval would provide meaningful benefits, stating that it offers another solution for addressing one of the most difficult consequences of disease progression.
Overity is available in the form of an immediate-release extended-release tablet. The FDA advises healthcare providers to monitor blood pressure, screen for any history of bipolar disorder, and check for any other medications patients might be taking, such as bupropion or dextromethorphan, before prescribing Overity.
As for side effects, the FDA reports that dizziness, upset stomach, headaches, diarrhea, drowsiness, dry mouth, sexual dysfunction, and excessive sweating are among the most common.
This treatment also carries a risk of seizures, which can increase with dosage, along with other potential issues like elevated blood pressure and mania in certain patients.
Additionally, the prescribing information warns about the potential for increased suicidal thoughts in younger adults, prompting healthcare professionals to closely monitor patients for such behaviors.
Dr. Mark Siegel, a senior medical analyst, lauded the approval, highlighting that Overity targets two areas in the brain linked to reducing both agitation and depression in older adults with dementia, including those with Alzheimer’s. He noted that this treatment is preferable to antipsychotics since it generally causes less drowsiness and is better tolerated by the elderly heart.
