10.20.21
‘Impressive’ Results for Novel Antidepressant, So Why the FDA Delay?

A novel antidepressant (AXS-05, Axsome Therapeutics) appears to have a rapid and durable effect in patients with major depressive disorder (MDD), results of an open label, phase 3 trial, show. Yet, its new drug application (NDA) remains in limbo with the US Food and Drug Administration (FDA) for reasons that are unclear. In the study,