Early Treatment Response and Safety Profile of AXS-05 in Phase 3 ACCORD Trial: Anton P. Porsteinsson, MD

WATCH TIME: 6 minutes

"It's important because when patients finally seek treatment for agitation and aggression that’s been going on for quite a while and has gotten to a critical point, they want to see a response that can suppress this behavior to some degree in a relatively short timeframe."

In Alzheimer disease (AD), agitation and irritability can be among the more difficult symptoms to manage and both may require nonpharmacological and pharmacological treatments to address them.¹ Treatment for these symptoms in AD generally starts with clinicians recommending a nonpharmacological intervention and followed by a pharmacologic therapy if needed. Psychotropic medications are frequently used off-label to manage these symptoms since there are limited treatments approved for agitation and irritability in AD. Overall, there is a need for more medications specific to treating the symptomatic effects of AD.

Recent findings from the phase 3 ACCORD trial (NCT04797715) showed that AXS-05 (Axsome Therapeutics), an investigational agent, significantly reduced the risk of agitation symptom relapse in patients with AD. Among 178 patients enrolled in the open-label period, the agent met its primary end point in delaying time to relapse of agitation symptoms as compared with placebo (HR = 0.276; P =.014) over the 26-week double-blind period with responders. These latest results were presented in a clinical trial plenary session at the 2024 American Academy of Neurology (AAN) Annual Meeting, held April 13-18, in Denver, Colorado, by Anton P. Porsteinsson, MD, director of the Alzheimer's Disease Care, Research and Education Program at University of Rochester.²

Following the meeting, Porsteinsson, who also serves as the William B. and Sheila Konar Professor of Psychiatry at University of Rochester School of Medicine and Dentistry, sat down with NeurologyLive® for an interview to discuss how the safety profile and early treatment response of AXS-05 in the ACCORD study compared with previous studies involving similar medications. He also spoke about the potential implications of the rapid treatment response observed in ACCORD for clinical practice and patient care in AD. Additionally, Porsteinsson talked about how the reported adverse events may impact the overall tolerability and acceptance of AXS-05 as a treatment option.

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REFERENCES
1. Koenig AM, Arnold SE, Streim JE. Agitation and Irritability in Alzheimer's Disease: Evidenced-Based Treatments and the Black-Box Warning. Curr Psychiatry Rep. 2016;18(1):3. doi:10.1007/s11920-015-0640-7
2. Cummings J, Grossberg G, Andersson C, Streicher C, and Tabuteau H. Efficacy and Safety of AXS-05 in Agitation Associated with Alzheimer’s Disease: Results from ACCORD, a Phase 3, Double-blind, Placebo-controlled, Relapse Prevention Trial. Presented at: 2024 AAN Annual Meeting; April 13-18; Denver, CO. Clinical Trials Plenary Session.