Major Depressive Disorder: Developing Drugs for Treatment Guidance for Industry

Major Depressive Disorder: Developing Drugs for Treatment Guidance for Industry

Today the U.S. Food and Drug Administration published a concise guidance that highlights current advice to sponsors for clinical development of drugs for the treatment of major depressive disorder (MDD). Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. The guidance: Includes advice for rapid-acting antidepressant development programs that covers nonclinical and clinical pharmacology studies, and clinical trial design features unique to this class of products, Addresses the distinction between partial response and treatment-resistance, both in terms of study designs and potential labelling claims, and Clarifies the pediatric study requirements, describing relevant age groups and noting that extrapolation of efficacy from adult studies is not acceptable. This draft guidance is intended to serve as a focus for continued discussions among the Division of Psychiatry Products, pharmaceutical sponsors, the academic community, and the public.