US FDA Approves Axsome's Drug for Alzheimer's-Related Agitation

FDA approves 1st non-antipsychotic medication for agitation in Alzheimer's disease

The Food and Drug Administration headquarters is shown in White Oak, Md. (Al Drago/CQ Roll Call via Getty Images, FILE) (NEW YORK) — The Food and Drug Administration (FDA) approved the drug Auvelity this week for the treatment of agitation in adults with Alzheimer’s dementia. The extended-release tablet is the first FDA-approved medication for this condition that is not an anti-psychotic. Anti-psychotics carry serious risks including stroke, sed…

Axsome Drug’s FDA Approval Unlocks New Opportunity in Alzheimer’s Agitation

Axsome Therapeutics’ Auvelity expanded its label to include treating agitation in Alzheimer’s disease patients. It’s just the second FDA-approved drug for this indication, and Axsome’s pill has a safety advantage.

Axsome wins FDA nod for Alzheimer's agitation

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FDA approves first non-antipsychotic drug for Alzheimer's agitation, driving Axsome shares up 12%

Auvelity, already on the market for depression, avoids the black box warning carried by the only other approved treatment for the condition

Axsome breaks new ground in Alzheimer's with Auvelity OK

Axsome's Auvelity has become the first non-antipsychotic therapy for agitation in patients with Alzheimer's disease to be approved by the FDA.

Axsome Therapeutics Announces FDA Approval of AUVELITY® (dextromethorphan HBr and bupropion HCl) for the Treatment of Agitation Associated with Dementia due to Alzheimer's Disease

AUVELITY is a first-in-class treatment, which targets the NMDA and sigma-1 receptors, approved for agitation associated with dementia due to Alzheimer’s disease