FDA Approves New Option for Postpartum Depression
The FDA has approved Zulresso (brexanolone) injection, the first drug approved by the FDA specifically for the treatment of postpartum depression (PPD) in adult women.
The drug will only be available through a restricted program requiring it to be administered by a health care professional in a certified health care facility. It is administered as a continuous intravenous infusion over a total of 60 hours. Continuous pulse oximetry monitoring must be provided to patients receiving the drug, due to a risk of sudden loss of consciousness. Patients must also be accompanied during interactions with their children while receiving the infusion.
The efficacy of Zulresso was demonstrated in 2 clinical studies in which women received either the drug or placebo and were followed for 4 weeks. The first study included women with severe PPD while the second included women with moderate PPD. In both studies, Zulresso demonstrated superiority to placebo in the improvement of depressive symptoms.
The most common adverse reactions include sleepiness, dry mouth, loss of consciousness and flushing.
FDA approves first treatment for post-partum depression [press release]. March 19, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633919.htm?utm_campaign=031919_PR_FDA%20approves%20new%20drug%20for%20post-partum%20depression&utm_medium=email&utm_source=Eloqua.