The US Food and Drug Administration has approved Auvelity (dextromethorphan + bupropion) from American biopharmaceutical company Axsome Therapeutics for the treatment of agitation – excessive psychomotor agitation – associated with dementia due to Alzheimer’s disease. This is the second indication for the drug, which was previously used for major depressive disorder. The company expects to begin selling the medicine for Alzheimer’s patients as early as June, keeping the current list price of $1,248 per month before discounts.
Following the approval, Axsome’s shares rose 12%, and the company’s market capitalisation surpassed $10 billion, more than doubling since the start of 2025.
With the new approval, Auvelity enters a market that already includes Rexulti (brexpiprazole) from Denmark’s Lundbeck and Japan’s Otsuka Pharmaceutical, which received a similar approval in 2023. Both drugs are taken orally, but Auvelity is the first non-antipsychotic therapy for this indication. Moreover, unlike its competitor, it carries no warning about an increased risk of death in dementia patients.
Agitation is one of the most severe manifestations of Alzheimer’s disease. It is associated with accelerated cognitive decline, admission to care facilities and an increased risk of death. Experts estimate that among the approximately 7 million Alzheimer’s patients in the United States, up to 76% experience agitation symptoms, making this one of the key unmet medical needs.
Meanwhile, Axsome is already posting strong commercial results: in 2025, Auvelity sales grew 74% to $507 million, intensifying competition with Rexulti, whose sales rose 23% to around $973 million.
Auvelity acts on NMDA and sigma-1 receptors, affecting neurotransmitters linked to disease symptoms including agitation and aggression. The drug’s efficacy has been confirmed in four clinical trials involving more than 1,000 patients. Specifically, the Advance-1 study showed a statistically significant reduction in symptoms compared with placebo, while the Accord-2 study demonstrated longer time to relapse when treatment was continued.
Rexulti is registered in Russia. However, it has not been included on the list of vital and essential drugs because the manufacturer refused state price regulation, even though the Russian Health Ministry’s drug list commission recommended adding it in 2024. There are currently no direct structural analogues (generics) with the active ingredient brexpiprazole in Russia.
