epocrates
Five things to know about the first oral medication for postpartum depression
Five things to know about the first pill for postpartum depression:
1) Zuranolone (Zurzuvae) works more quickly than current SSRI antidepressant treatments for postpartum depression.
Until a few years ago, clinicians treated postpartum depression with a combination of psychotherapy and SSRIs. However, it can take up to three months for people to respond to these drugs, and they may need to be taken indefinitely.
In contrast, Zurzuvae is recommended in once-daily doses of 50 mg for two weeks. The most common adverse reactions (≥5% and greater than placebo) in Zurzuvae-treated patients were somnolence, dizziness, diarrhea, fatigue, and UTI (FDA, 2023).
FDA based its approval of zuranolone, in part, on a placebo-controlled, RCT trial where nearly 196 women with severe postpartum depression were given either 50 mg per day of zuranolone or a placebo pill for 14 days. Symptom severity was measured using the 17-item Hamilton Depression Rating Scale. After three days of treatment, those who received zuranolone experienced significant relief from depressive symptoms. At day 15, the treatment group showed a 29.4 percent greater improvement in depression scores, compared with the placebo group. Significant improvements in depressive symptoms persisted 45 days after treatment began (Tu, 2023; Deligiannidis, 2023)
It’s unclear, however, how long zuranolone’s benefits persist beyond 45 days.
2) An oral medication may be easier for patients to take than the other FDA-approved medication for postpartum depression, IV brexanolone.
In 2019, the FDA approved brexanolone (Zulresso) as the first drug specifically for the treatment of postpartum depression. But brexanolone isn’t widely used because it costs $34,000 per dose, carries a risk of loss of consciousness, and requires 60-hour IV infusion in a hospital (Tu, 2023; Belluck, 2023).
3) It’s not yet known how much zuranolone will cost.
Zuranolone was developed by Sage Therapeutics, a Massachusetts company that produces it in partnership with Biogen. The companies have not yet announced a price for the pill (Belluck, 2023).
4) Although many cases of maternal depression begin in pregnancy, zuranolone is not being recommended until after childbirth as it wasn't tested in pregnant women. Nor is there data on the drug's effect on lactating mothers (FDA, 2023).
Zuranolone's label warns that the drug could cause harm to a fetus and advises women to use contraception while taking the pill and for a week afterward.
The medication's label also includes warnings about possible suicidal thoughts and behavior, sleepiness and confusion, and a 'black box warning' that patients shouldn't drive or operate heavy machinery for at least 12 hours after taking the pill.
5) Since it was specifically approved for the treatment of postpartum depression, zuranolone may help destigmatize the condition by highlighting the biological underpinnings of a disease that affects about a half-million women in the U.S. every year.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings” (FDA, 2023).
Zuranolone has been FDA-approved only for the specific treatment of postpartum depression; the FDA rejected Sage and Biogen's application to have the drug approved for the treatment of major depressive disorder, saying that an additional study or studies would be needed to provide more evidence (Belluck, 2023).
Sources:
(2023, Aug 4). FDA. FDA Approves First Oral Treatment for Postpartum Depression. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-postpartum-depression
Tu, L. (2023, Aug 7). Scientific American. First Pill for Postpartum Depression Approved. https://www.scientificamerican.com/article/first-pill-for-postpartum-depression-approved/
Belluck, P. (2023, Aug 4). The New York Times. For the First Time, There's a Pill for Postpartum Depression. https://www.nytimes.com/2023/08/04/health/postpartum-depression-pill-fda.html
Deligiannidis, KM, et al. (2023, July 26). Am J. Psychiatry. Zuranolone for the Treatment of Postpartum Depression. https://pubmed.ncbi.nlm.nih.gov/37491938/