An FDA-Approved Novel Drug in 2023

The role of steroids in psychiatric disorders has captivated the attention of many researchers. One such specific agent with neuroactive properties is Zuranolone, the first oral medication approved for postpartum depression. It is a gamma-aminobutyric acid (GABA) and a receptor-positive modulator.

Specifically, Zuranolone is a synthetic analog of allopregnanolone which is synthesized in the brain from progesterone by the action of two enzymes: 5α-reductase and 3α-hydroxysteroid dehydrogenase.

A Randomized, Placebo-Controlled Phase 3 Trial concluded that Zuranolone at 50 mg per day resulted in a significantly greater improvement in depressive symptoms at day 15. This finding underscores the importance of steroid hormones in the complex mechanism of depression, specifically in the postpartum type.

FDA Schedule for Zuranolone below or Download.

Dr. Caroline Stamu-O’Brien………………………….