Axsome Therapeutics has announced that the US Food and Drug Administration has approved Auvelity for the treatment of agitation associated with dementia due to Alzheimer’s disease. The approval marks an advancement in addressing one of the most challenging neuropsychiatric symptoms of the disease.

Auvelity is a first-in-class oral therapy that targets the NMDA and sigma-1 receptors in the brain, offering a novel mechanism of action for managing agitation. Alzheimer’s disease, the most common form of dementia, affects more than 7 million people in the United States, with agitation reported in up to 76 percent of patients. Symptoms can include restlessness, irritability and aggressive behaviour, often placing a heavy burden on caregivers and healthcare systems.

The FDA’s decision is supported by results from the Phase III ADVANCE-1 and ACCORD-2 clinical trials. In these studies, Auvelity demonstrated statistically significant improvements in agitation symptoms compared to placebo and showed a longer time to relapse in patients continuing treatment. The therapy also exhibited a favourable safety and tolerability profile, with low discontinuation rates comparable to placebo.

Experts note that agitation in Alzheimer’s patients is associated with faster cognitive decline, increased likelihood of institutionalisation, and higher mortality risk, making effective treatment options critical. The approval of Auvelity provides clinicians with a new, targeted option for managing this complex condition.

Previously granted Breakthrough Therapy designation and Priority Review by the FDA, Auvelity has already been approved for major depressive disorder and has been used in over 300,000 patients. Axsome Therapeutics stated that the approval reinforces its commitment to developing innovative treatments for central nervous system disorders and improving patient outcomes.