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FDA Grants Priority Review to Drug for Depressive Disorders

The bleakness and challenges associated with depression are long-standing problems newly complicated by the pandemic. 

But doctors and hospitals currently overwhelmed by those seeking help might soon have a new tool to support people experiencing major depressive disorder and new mothers experiencing postpartum depression. 

Two-Week Treatment 

The FDA recently granted zuranolone priority review. The status is reserved for medicines which, if approved, would provide significant improvement in the effectiveness of treatment, diagnosis or prevention of a serious condition. Under the priority review system, the FDA is scheduled to act on the application for this drug in early August. 

Zuranolone is being evaluated as a rapid-acting, 14-day oral treatment for adults with postpartum depression or major depressive disorder. Its reported ability to relieve symptoms in two weeks makes it a potentially game-changing option, as current medications can take several months to show results. 

The drug itself is a neuroactive steroid. In people with depression, it works by rebalancing deregulated neuronal networks to help reset brain function. Zuranolone is designed to target brain networks responsible for mood, arousal, behavior and cognition, among other functions. 

While there is a wide variety of depression treatments available, most clinicians are welcoming of new treatment options. Different mental health patients with the same diagnosis frequently do not respond well to the same medications. 

An Increasing Burden 

Rates of depressive disorders tripled early in the pandemic and continue to rise. It’s estimated that 21 million adults in America experienced at least one major depressive episode in 2020, with nearly 14 million diagnosed with major depressive disorder. 

And as many as one in seven new mothers in the U.S. experiences postpartum depression, totaling more than half a million cases annually. Like the country’s maternal mortality and infant death rates, the condition disproportionately affects women of color. Postpartum depression adds stress to women’s – and whole families’ – lives at a time that is already stressful. In severe cases, it can leave mothers unable to care for themselves, their new babies or their families. 

The impact of both conditions makes a strong case for expanding treatment options. Hopefully, zuranolone will be a step in that direction. 

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