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The drug offers a new treatment option for patients with Alzheimer's-related agitation.
The FDA has approved Axsome Therapeutics' Auvelity for agitation in Alzheimer's patients.
KEY POINTS
Auvelity provides an alternative to antipsychotics, which carry serious safety risks for these patients.
Up to 70% of U.S. Alzheimer's patients experience agitation, previously lacking a safer treatment option.
Auvelity is the first FDA-approved drug specifically targeting Alzheimer's-related agitation.
The U.S. Food and Drug Administration has approved Axsome Therapeutics' drug to treat agitation in patients with Alzheimer's disease, the company said on Friday.
The drug, branded as Auvelity, offers a new treatment option for patients with Alzheimer's-related agitation, marked by restlessness, aggression and emotional distress. These patients have long relied on antipsychotic drugs, which had serious safety risks.
Alzheimer's disease, the most common form of dementia, affects about 7 million people in the United States. Agitation occurs in up to 70% of the patients, contributing to faster cognitive decline, heavier burden on caregivers, and higher risk of death.