FDA approves Auvelity to treat Alzheimer’s-related agitation

The U.S. Food and Drug Administration (FDA) has approved a new first-in-class treatment, Auvelity (dextromethorphan-bupropion), for the treatment of agitation associated with Alzheimer’s disease.

Auvelity is now the only FDA-approved treatment for Alzheimer’s-related agitation that is not classified as an antipsychotic, according to the Alzheimer’s Association.

“For too long, people living with Alzheimer’s disease agitation and their families have had limited options, and the options that existed came with significant risks,” Joanne Pike, the association’s president and CEO, said in a press release. “This approval gives patients, caregivers and clinicians an important new tool — one that works through a different mechanism than antipsychotic medications and that can help address a symptom that profoundly affects quality of life for people living with Alzheimer’s and those who care for them.”

Previously known as AXS-05, Auvelity was developed by Axsome Therapeutics. The company said that when it commercially launches the new medication, it will also launch a patient support program called Auvelity OnMySide, which will provide resources, including financial aid and insurance assistance, for eligible patients.