A recent study of zuranolone, a pill for postpartum depression, shows that the drug is both safe and effective. The medication is a breakthrough in the management of the demoralizing illness which may threaten the well-being, and even the lives, of women and their infants during the first year after delivery.
Postpartum depression is a devastating mental illness that also affects a woman’s physical health. Sad, flat, or empty feelings are common a few days after a baby’s birth and usually resolve in a few more days. With postpartum depression, however, those feelings do not go away and interfere with day-to-day life.
The woman might feel unconnected to her baby as if she is not the baby’s mother. She may not feel love for her baby, may have thoughts of hurting her infant, or even be unable to care for her child. These feelings can be mild to crippling. The mother often feels intense shame, hiding her symptoms and making it difficult to detect and treat the illness.
Zuranolone, a drug specifically for postpartum depression, given as a daily pill over the course of two weeks, has been granted “priority review” by the U.S. Food and Drug Administration (FDA), according to the makers of the drug, Sage Therapeutics and Biogen.
A “priority review” designation means the FDA “will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be
significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications,” according to the agency.
The FDA is expected to determine approval status by Aug. 5, 2023.
The study of 196 women with severe postpartum depression found that those who took a daily 50-milligram dose of zuranolone in a pill for 14 days showed significant improvements in depressive symptoms, compared with those who were given a placebo. Dr. Kristina Deligiannidis, a professor at the Institute of Behavioral Science at the Feinstein Institutes for Medical Research in New York, was the lead scientist.
Among the women who took zuranolone, the researchers noted favorable responses to the treatment as early as day three. Currently, available antidepressant drugs may take weeks to become effective. These improvements were still present 28 and 45 days later.
The day after the women completed the 14-day treatment course, the researchers found that 57 percent reported a 50-percent or greater improvement in their depressive symptoms, compared with 38 percent of those on a placebo.
At 45 days after initiation of treatment, 61.9 percent of participants who received zuranolone, compared with 54.1 percent of those taking a placebo, reported a 50-percent or greater improvement in their depressive symptoms.
Drowsiness was reported by 26.5 percent of the women taking zuranolone, 13.3 percent had dizziness, and 11.2 percent experienced sedation. A smaller number of participants had headaches, diarrhea, and nausea.
“Since zuranolone is an acute, 14-day treatment course, the medication is not taken chronically. Any side effects should be confined to the short treatment
course,” Deligiannidis says in a statement.
Since the trial stopped assessment at just 45 days, further studies are needed to determine the long-term impact of zuranolone, the safety of the drug while
breastfeeding, and its effects on parent-child interaction.
The study was funded by Sage Therapeutics and Biogen, developers and manufacturers of the drug.
4 resources for mothers and supporters of mothers with postpartum depression:
1. Postpartum Mood Disorders: An Informational Guide for Couples — This is an excellent resource for individuals as well as couples.
2. Hotline for postpartum depression: 1-800-PPD-MOMS (773-6667). This number can be used for any postpartum emotional needs.
3. Postpartum Progress, a community of peers — One of their excellent resources is a maternal mental health checklist, for your understanding and for communication with healthcare providers.
4. There are several helpful books available, including “This Isn’t What I Expected” by Karen Kleiman and “Down Came the Rain: My Journey Through Postpartum Depression” by Brooke Shields.