Axsome Therapeutics said the FDA approved Auvelity for agitation associated with dementia due to Alzheimer’s disease, giving the company a second approved use for the drug and expanding its commercial opportunity beyond major depressive disorder.
The approval was backed by two phase 3 studies. In the 5-week ADVANCE-1 trial, Auvelity beat placebo on the primary endpoint, with a statistically significant improvement in agitation symptoms at week 5 as measured by the Cohen-Mansfield Agitation Inventory total score. On the key secondary endpoint, a greater proportion of patients on Auvelity were rated at least minimally improved on the modified Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change.
In the longer ACCORD-2 withdrawal study, patients who stayed on Auvelity had a statistically significantly longer time to relapse than those switched to placebo. The company did not provide the exact relapse-time figures in the release.
Safety data from ADVANCE-1 showed 1.3% of patients discontinued Auvelity because of an adverse event, the same rate as placebo. The most common adverse reactions, occurring in at least 5% of Auvelity patients and more than twice as often as placebo, were dizziness and dyspepsia.
Axsome said Alzheimer’s disease affects more than 7 million Americans, and agitation is reported in up to 76% of patients with the condition. The company also said Auvelity has now been administered to more than 300,000 patients in clinical and real-world settings.
The approval marks the second neuropsychiatric indication for Auvelity to receive breakthrough therapy designation, priority review and FDA approval. Axsome said it will host a webcast on May 1 at 8:00 a.m. Eastern time to discuss the approval. Following these announcements, the company's shares moved 1.77%, and are now trading at a price of $185.96. For the full picture, make sure to review Axsome Therapeutics's 8-K report.
