Biopharmaceutical company Axsome Therapeutics announced that its innovative drug Auvelity® (a combination of dextromethorphan hydrobromide and bupropion hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of agitation associated with dementia due to Alzheimer's disease.

This approval marks a significant expansion of Auvelity®'s indications, providing a new pharmaceutical option for the treatment of agitation symptoms associated with Alzheimer's disease. Agitation symptoms are common neuropsychiatric manifestations in patients with dementia and pose considerable challenges to the quality of life of both patients and their caregivers. As a novel oral therapy, Auvelity® features a unique dual-action mechanism designed to regulate neurotransmitter systems related to mood and behavior. The drug's approval is based on the efficacy and safety data demonstrated in clinical trials.