FDA Approves First Pill for Postpartum Depression

Facts

• On Friday, the US Food and Drug Administration (FDA) approved Zurzuvae — the first oral pill to treat postpartum depression (PPD).¹
• According to scientists, taking Zurzuvae once a day for 14 days seems to ease symptoms of adults experiencing severe depression related to childbirth or pregnancy for months at a time. However, additional courses of the medication may be needed.²
• According to drugmakers Sage Therapeutics and Biogen, Zurzuvae is expected to be commercially available in the fourth quarter of 2023 after the US Drug Enforcement Administration schedules it as a controlled substance.³
• PPD reportedly affects an estimated 400K women a year, and the FDA states Zurzuvae could benefit "many of these women coping with extreme, and sometimes life-threatening, feelings."⁴
• Previously, the only FDA-approved treatment for PPD was Zulresso, an intravenous injection that could be administered only in certain healthcare facilities.⁵
• Zurzuvae's approval is based on two randomized, double-blind, placebo-controlled, multicenter studies that showed women who took the pill had fewer signs of depression over four to six weeks than those who received a dummy pill.⁶

Sources: ¹NBC, ²CBS, ³Reuters, ⁴Associated Press, ⁵Washington Post, and ⁶U.S. Food and Drug Administration.

Narratives

• Narrative A, as provided by The Wall Street Journal. Postpartum depression is a serious and potentially life-threatening condition that typically lasts longer than the anxiety or fatigue many women experience after giving birth. Zurzuvae's approval is a game changer for women's mental health and maternal depression, as the pill will dramatically expand the number of women who can be treated for their inability to feel pleasure and suicidal ideations following childbirth.
• Narrative B, as provided by STAT. While this is a promising development, it only addresses one side of the equation: The first step in treating PPD is diagnosing those at risk of maternal mental health complications. In the US, as many as 50% of PPD cases are overlooked, leaving mothers unwittingly victims of this crippling illness. It's time to normalize PPD and develop the much-needed systems for accurate diagnoses.