AXS-05, a combination of dextromethorphan and bupropion, led to a rapid and sustained improvement in agitation related to Alzheimer's disease in the phase 3 ACCORD trial.
More than half of participants in the open-label extension period of the randomized clinical trial responded to the medication, which was associated with a 3.6-fold lower risk for relapse compared with placebo.
In the open-label period, 178 adults with probable AD and clinically significant agitation received AXS-05 for up to 9 weeks. Rates of discontinuation in the double-blind period owing to adverse events were low . Three serious AEs were reported: one in the AXS-05 group , which was not related to study medication, and two in the placebo group (cardiac arrest,
"Agitation is a common, distressing, and sometimes safety issue for people fighting Alzheimer's disease, and there's very little evidence for efficacy and significant side effect issues for current medical management of agitation in Alzheimer's disease," said Finney, who was not part of the study.
Alzheimer Disease Agitation Antipsychotics Neuroleptics Neuroleptic Drugs Healthcare And Medical Technology Health And Medical Tech Health And Med Tech Health And Medical Technology Healthcare Technology Medical Technology U.S. Food And Drug Administration United States Food And Drug Administration Fda Patient Safety
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