Following the news that the FDA has approved Axsome Therapeutics’ Auvelity (dextromethorphan + bupropion) for the treatment of agitation associated with dementia due to Alzheimer’s disease (AD);

Philippa Salter, Managing Neurology Analyst at GlobalData, a leading intelligence and productivity platform, offers her view:

“A major unmet need in the AD market is for treatments for the many secondary symptoms associated with the disease that can negatively impact THE quality of life for both patients and caregivers. the key opinion leaders (KOLs) previously interviewed by GlobalData highlighted agitation as being a particularly distressing symptom with a lack of good treatment options.

“When agitated, patients are often prescribed antipsychotic medications and sedatives off-label to alleviate behavioral issues. However, the FDA states that this practice can be dangerous in elderly patients. Indeed, the FDA label for the first FDA-approved treatment for agitation associated with AD, Rexulti (brexpiprazole), approved in 2023, contains a black boxed warning for increased mortality in elderly patients with dementia-related psychosis.

“In pivotal Phase III trials Auvelity was well tolerated and was not associated with sedation or cognitive decline. The overall safety profile for Auvelity is already well established following its approval for major depressive disorder in the US in 2022. Not having a black box warning in elderly patients is a clear advantage for Auvelity in the AD patient population.

“According to the KOLs, despite being first to market in the US, Rexulti has an efficacy profile only comparable to other atypical antipsychotics and thus does not provide a significant improvement for AD agitation treatment. Auvelity has demonstrated both short-term efficacy for reducing agitation, as well as longer-term efficacy for being able to prevent relapse of AD agitation. As such, it provides a breakthrough as an alternative, novel treatment option in the US.”