- The first pill for postpartum depression, zuranolone, is nearing FDA approval.
- A study showed results within 3 days and improved functioning a month after stopping the meds.
- PPD affects 1 in 8 women but current treatments can be slow-acting.
- Visit Insider's homepage for more stories.
New moms with postpartum depression may soon be able to take a pill – and feel their mood improve in a few days.
Weeks after the drug's 14-day course is complete, most will remain in remission from postpartum mood disorders, new research from the Feinstein Institutes for Medical Research suggests.
The pill, which is not yet FDA-approved, is set to become the first oral treatment for people with severe perinatal mood disorders.
Gaps in treatment
Postpartum depression affects 1 in 8 women in the US, causing mood swings, feelings of hopelessness, withdrawal from family and friends, and panic attacks.
Left untreated, the disorder can affect the mom's physical and mental health, the baby's development, and the relationship between mom and baby. Suicide is a leading cause of maternal death.
And yet treatments are lacking: Antidepressants and talk therapy can work for new moms, but usually not quickly. The one FDA-approved drug for PPD, Zulresso, is fast-acting, but requires a 60-hour IV infusion that's administered in the hospital.
The drug on the horizon, called zuranolone, is the pill variation of Zulresso. It aims to offer new moms something they can take at home for only two weeks and experience lasting results.
Kay Matthews, a Feinstein Institutes patient advocate who suffered postpartum depression before founding Shades of Blue to support postpartum women of color, told Insider the drug will be a "game-changer." "It allows for more flexibility" in new moms' daily lives, she said.
Repairing a malfunctioning brain circuit
Having a traumatic birth or poor social support can put a mom at risk for PPD.
But there's a hormonal aspect, too: After birth, the level of some hormones drop dramatically, and the brain is supposed to reorient to support parenting, principal investigator Dr. Kristina Deligiannidis told Insider.
"Once you become a mother, your brain thinks differently," she said.
But in some new parents, something goes wrong in that rewiring process, boosting the risk for perinatal mood disorders. Taking zuranolone, a tweaked synthetic form of one hormone, allopregnanolone, helps repair that circuit.
53% remained in remission for weeks
The study - a rigorous double-blinded phase-3 clinical trial - involved 151 new moms at 33 clinics across the US. The women were six months postpartum or less, each diagnosed with severe PPD. Most patients identified as white or Black.
The participants were randomly assigned to take either a placebo or 30 milligrams of zuranolone each night for 14 days, while researchers tracked their depressive symptoms and functioning.
By day three, those on the pill were improving more than those on the placebo. By day 15, 45% of those taking the drug were in remission compared to 23% of those on the placebo. By day 45 - a month after stopping the pill - 53% of the zuranolone patients were in remission versus 30% who received the placebo. Even those not in full remission saw significant reductions in their symptoms and functioning.
"They were feeling so hopeless and so helpless. They felt worthless as a mother, and this just wiped that away," Deligiannidis said. "They felt fully capable as women, as mothers, of taking care of their families, of going back to work, and doing everything that they wanted to do."
Testing the drug's safety during breastfeeding
Common side effects of both the pill and placebo were mild, like fatigue and headaches. One participant experienced a "confusional state" and "sedation" on zuranolone, though, and another stopped the trial because of its sedative effects.
More research is needed to see how well women do beyond 45 days. It's also unclear if the drug is safe while breastfeeding, since the participants were told to stop nursing while on the pills and for one week after.
That, and the potential cost, are the drug's biggest barriers, Dr. Katherine L. Wisner, an OB-GYN who studies maternal mental health but wasn't involved in the study, told Insider.
Meantime, Deligiannidis encourages women experiencing perinatal mood disorders to speak up. "Women should not feel the stigma, they should not feel alone, and they shouldn't blame themselves," she said. "It's not their fault."