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- Aug 4, 202390% CONFIDENCEfrom the source
FDA Approves Zurzuvae, the First Pill for Postpartum Depression
- The FDA approved Zurzuvae (zuranolone) on 4 August 2023 as the first oral medicine for postpartum depression in adults[1][3]
- Until then PPD treatment was only an IV infusion given in certain health care facilities (Sage's Zulresso)[1][4]
- The FDA declined to approve it for major depressive disorder the same day[3][4]
- Sage and Biogen priced the two-week course at $15,900 in November 2023 and planned to start selling it that December, after DEA scheduling[2]
- The application had Priority Review and Fast Track designation[1]
Notable features
- 50 mg once daily in the evening with a fatty meal, for 14 days[1]
- In two placebo-controlled trials, women improved significantly on the HAMD-17 depression scale at day 15, and the effect held at day 42[1]
- Boxed warning: patients should not drive or operate heavy machinery for at least 12 hours after a dose[1]
References 589% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depressionfda.gov· Posted Sep 25, 2026· Starts Aug 4, 2023 ✓· 95% of score
The FDA news release is headed "For Immediate Release: August 04, 2023" and says "Today, the U.S. Food and Drug Administration approved Zurzuvae (zuranolone), the first oral medication indicated to treat postpartum depression".
- [2]80%Biogen, Sage set price of postpartum depression pill at $15,900 (BioPharma Dive)biopharmadive.com· Published Nov 7, 2023· 2% of score
The two-week course was priced at $15,900, with sales planned from December 2023 once DEA scheduling was done; the MDD rejection sharply limited its market.[1]
- [3]85%FDA approves Sage Therapeutics' rapid-acting medication for postpartum depression but not major depression (STAT)statnews.com· Published Aug 4, 2023· 1% of score
STAT: approved Friday as the first oral treatment for PPD, taken for 14 days; the application for major depression was denied.[1]
- [4]80%Sage, Biogen Drug Is Now the First Approved Oral Med for Postpartum Depression (MedCity News)medcitynews.com· Published Aug 4, 2023· 1% of score
Zurzuvae is Sage's second PPD approval after the 2019 IV drug Zulresso; it did not win approval in major depressive disorder, a blow to the Sage-Biogen partnership.[1]
- [5]75%FDA Approves Zuranolone, a Pill for Postpartum Depression Treatment (Policy Center for Maternal Mental Health)policycentermmh.org· Published Aug 4, 2023· 1% of score
Maternal mental health advocates on why an oral 14-day treatment an OB-GYN or midwife can prescribe matters.[1]
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