Axsome receives FDA approval for Auvelity to treat Alzheimer’s agitation

Auvelity is a first-in-class therapy targeting both N-methyl D-aspartate (NMDA) and sigma-1 receptors for this indication.

The FDA’s decision is based on results from the Phase III ADVANCE-1 and ACCORD-2 studies.

ADVANCE-1 was a five-week, double-blind, parallel-group trial comparing Auvelity to a placebo and bupropion (bupropion arm discontinued early for futility).

Auvelity showed statistically significant improvement over placebo in reducing agitation symptoms as measured by the Cohen-Mansfield Agitation Inventory (CMAI) at week five.

ACCORD-2, a long-term, double-blind, randomised withdrawal study, found that patients continuing Auvelity had a significantly longer time to relapse than those who switched to placebo.

Auvelity works by modulating NMDA and sigma-1 receptors via dextromethorphan, with bupropion increasing its blood levels by inhibiting cytochrome P450 2D6 (CYP2D6).

The precise mechanism of action in Alzheimer’s agitation remains unclear. Auvelity is also approved for major depressive disorder in adults.

Axsome CEO Herriot Tabuteau said: “The approval of our first-in-class medication for agitation associated with Alzheimer’s disease marks an important milestone for the millions of patients living with Alzheimer’s disease, their families, and their caregivers.

“We are very pleased to deliver to clinicians and patients a new, effective, FDA-approved treatment option, with a distinct mechanism of action, for this debilitating and critically underserved condition.

“Alzheimer’s disease agitation is the second neuropsychiatric indication for which Auvelity has received FDA breakthrough therapy designation, and been granted FDA priority review and approval, underscoring Axsome’s pioneering work in neuroscience and our dedication to people living with serious brain health conditions.”

Welcoming the FDA’s approval, Alzheimer’s Association president and CEO Joanne Pike said: “For too long, people living with Alzheimer’s disease agitation and their families have had limited options, and the options that existed came with significant risks.

“This approval gives patients, caregivers and clinicians an important new tool — one that works through a different mechanism than antipsychotic medications and that can help address a symptom that profoundly affects quality of life for people living with Alzheimer’s and those who care for them.”

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