FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves First Post-Partum Depression Treatment

March 28, 2019

The FDA approved Sage Therapeutics’ Zulresso (brexanolone) as the first ever drug specifically for treatment of post-partum depression.

Zulresso came through the FDA’s priority review and breakthrough therapy programs and showed, through two clinical trials, that it was more effective at dealing with depression symptoms than a placebo.

The treatment requires an IV infusion for 60 hours and the FDA requires patients to have their blood pressure and blood oxygen levels monitored continually while hooked up to the IV.

Zulresso will carry a black box warning and be supervised under a REMS program. The drug will carry a list price of $34,000 per year.

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