First Non-Antipsychotic Treatment for Alzheimer’s Anxiety Approved by Axsome
AUVELITY’s indication has been expanded to include the treatment of agitation associated with Alzheimer’s disease–related dementia. On April 30, the U.S. Food and Drug Administration approved the supplemental New Drug Application for AUVELITY, a dextromethorphan-bupropion combination, granting it an indication for Alzheimer’s-related agitation. This approval was based on Phase III ADVANCE-1 and ACCORD-2 trials, which demonstrated significant improvement in agitation symptoms and delayed relapse versus placebo. Following Breakthrough Therapy designation and Priority Review, the FDA met its PDUFA target action date of April 30. AUVELITY is the first non-antipsychotic—and the second treatment overall after Rexulti—to receive approval for Alzheimer’s-related agitation, opening a new market opportunity in the U.S. amid a rapidly growing elderly dementia population.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a U.S. biotech specializing in central nervous system (CNS) disorders. Its lead product, AUVELITY, was approved in 2022 for major depressive disorder, and its portfolio also includes SUNOSI, indicated for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea. In 2025, Axsome generated approximately $571 million in AUVELITY sales, underscoring its role as the company’s flagship therapy. The expanded indication broadens AUVELITY’s prescribing base into Alzheimer’s-related behavioral disturbances. At the same time, Axsome is advancing multiple CNS candidates targeting conditions such as depression with comorbid sleep disorders, narcoleptic attacks, insomnia, and anxiety.
On April 1, prior to the FDA’s approval, Axsome entered an asset purchase agreement with Takeda Pharmaceutical Company to acquire worldwide commercial, development, and manufacturing rights for balipodect (TAK-063), a selective PDE10A inhibitor. Balipodect is an oral candidate that completed a Phase II proof-of-concept study in 164 schizophrenia patients. Axsome plans to pursue initial indications in schizophrenia and Tourette syndrome, aiming to initiate Phase III activities for schizophrenia by 2026. Under the agreement, Axsome will pay Takeda an upfront fee, development, regulatory and commercial milestones, plus royalties on future global net sales. Together with the AUVELITY label expansion, this acquisition strengthens Axsome’s growth story centered on a diversified CNS therapy portfolio.