The US Food and Drug Administration (FDA) released guidance on June 20, 2018 containing major revisions to its guidance on the clinical development of treatments for major depressive disorder (MDD), reported RAPS. The guidance is currently in draft form and contains major revisions to FDAs 1977 Guidelines for the Clinical Evaluation of Antidepressant Drugs.
The new guidance is eight pages long and applies to monotherapuetic, combination and adjunctive treatments for MDD. MDD is a common mood disorder which is characterized by a constant feeling of sadness or anxiety. However, FDA clarified that the recommendations do not apply to drugs intended to treat bipolar depression or to nonpharmacologic therapies.
The guidance mentions that clinical trial design and regulatory issues “may differ for rapid-acting antidepressant drugs, which are currently in development.”1 Furthermore, the guidance has been modernized to include more up-to-date evaluations, trial endpoints, study designs, as well as diagnosis tools.
Lastly, FDA says that sponsors should attempt to include patients with other conditions in their studies including but not limited to: renal insufficiency, cardiac disease, and patients with HIV.
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