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New treatment for postpartum depression
Postpartum depression can occur during the late stages of pregnancy or within 4 weeks after giving birth. Approximately 15% of new mothers develop postpartum depression, which is more severe than the common “baby blues” that many women experience after having a baby.1
Symptoms of postpartum depression are often serious, including severe depression or mood swings, crying too much, insomnia, overwhelming tiredness, withdrawing from family and friends, hopelessness, and in some cases thoughts of hurting oneself or one’s baby.2 Postpartum depression can also affect a new parent’s ability to bond with their baby or establish a connection with them, and can result in neglecting the child’s care.3
Unmet need for postpartum depression treatments
Until recently, the only treatment specifically approved to treat postpartum depression was a medication called Zulresso (brexanolone), which is administered by a 60-hour intravenous infusion, requires a stay in the hospital away from one’s baby, costs up to $34,000, and may cause loss of consciousness when administered.4
Other options for the management of postpartum depression have included psychotherapy and general antidepressant medications. However, it often takes several weeks for antidepressants to start improving symptoms, and in severe cases of postpartum depression, this may be too long to wait for relief.
FDA approves first pill for postpartum depression
This August, the U.S. Food and Drug Administration (FDA) approved the first ever pill for the treatment of postpartum depression, called Zurzuvae (zuranolone).5
Zurzuvae and the intravenous drug Zulresso share a mechanism of action that is different than that of general antidepressants. Both are synthetic versions of a chemical (allopregnanolone) that targets a mood-related neurotransmitter in the brain, but Zurzuvae is in a pill form. The recommended dose of Zurzuvae is 50mg, once daily for 2 weeks, with a “fatty meal” (ex. oils, avocados, nuts, eggs).5 Zurzuvae can be taken alone or with other antidepressant medications.
In clinical studies in women with postpartum depression who were not breastfeeding, Zurzuvae exhibited significantly improved depressive symptoms when compared to placebo.6,7 Effectiveness began much earlier than with general antidepressants, with improvements in symptoms observed just three days after starting treatment. These improvements were sustained, lasting for four weeks after the last dose was taken.6,7
The most common side effects were drowsiness, dizziness, diarrhea, and fatigue. Due to the drowsiness observed, the FDA has included a “black box” warning advising against driving or operating heavy machinery for at least 12 hours after taking Zurzuvae. Women taking Zurzuvae are advised to use contraception during treatment and for one week after the final dose, as fetal harm may occur. The drug has not been tested in mothers who are breastfeeding, so little is known about the effects on infants. Women who are breastfeeding would need to either stop breastfeeding or pump and discard their milk while on Zurzuvae. The prescribing label also includes a warning that Zurzuvae should be discontinued if suicidal thoughts develop.
Given that that the symptoms of postpartum depression can often be severe, the FDA panel felt that the potential benefits make Zurzuvae a useful option, despite the risk of side effects, especially for women who have not had relief with other treatments.5 The availability of an oral medication could improve access to treatment, and more patients may be willing to try a medication with a short duration of dosing along with rapid, sustained effectiveness.
- The drug is expected to become available in late 2023, at which time the drugmakers, Sage Therapeutics and Biogen, Inc., will release information on pricing and patient access programs, including copay assistance.8
- Kroska, E. B. & Stowe, Z. N. Postpartum Depression: Identification and Treatment in the Clinic Setting. Obstet Gynecol Clin North Am 47, 409–419 (2020).
- Depression During and After Pregnancy. Centers for Disease Control and Prevention https://www.cdc.gov/reproductivehealth/features/maternal-depression/index.html (2023).
- Postpartum Depression: Causes, Symptoms & Treatment. Cleveland Clinic https://my.clevelandclinic.org/health/diseases/9312-postpartum-depression.
- Commissioner, O. of the. FDA approves first treatment for post-partum depression. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-post-partum-depression (2020).
- Commissioner, O. of the. FDA Approves First Oral Treatment for Postpartum Depression. FDA https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression (2023).
- Deligiannidis, K. M. et al. Effect of Zuranolone vs Placebo in Postpartum Depression: A Randomized Clinical Trial. JAMA Psychiatry 78, 951–959 (2021).
- Deligiannidis, K. M. et al. Zuranolone for the Treatment of Postpartum Depression. AJP appi.ajp.20220785 (2023) doi:10.1176/appi.ajp.20220785.
- Howard, J. Drugmakers say they’re adjusting their ‘thinking on price’ of first postpartum depression pill approved in the US. CNN https://www.cnn.com/2023/08/08/health/zuranolone-pricing-postpartum-depression/index.html (2023).