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Postpartum depression is complex—and so is the first FDA-approved treatment. The 60-hour inpatient infusion process for Sage Therapeutics' Zulresso calls for more than the typical information and education.
The FDA announced Tuesday that it has cleared Sage Therapeutics' Zulresso (brexanolone) to treat postpartum depression (PPD) in adult women, making it the first drug approved in the US specifically for this indication.
Sage Therapeutics has the first-ever approval for a prescription drug for postpartum depression, thanks to the FDA’s Tuesday nod for Zulresso. But it also has a number of big challenges ahead.
The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
Sage Therapeutics has scored a big win with postpartum depression (PPD) drug SAGE-217, after rolling the dice on an upgraded clinical trial last summer.