The landmark approval of the first pill for post-partum depression offers an important new treatment for the 1 in 7 new mothers who experience post-partum depression.
Suicide is a leading cause of maternal mortality in the US. And yet on its own, the new drug — promising as it is — isn’t enough. Consider that as many as half of women with post-partum depression go undiagnosed.
Nonetheless, the new pill is a remarkable breakthrough, and one of several encouraging recent developments in women’s health — perhaps a sign that pharmaceutical companies are finally listening to the female half of the population.
Zuranolone, developed by Biogen and Sage Therapeutics, will be marketed as Zurzuvae. The most obvious upside of zuralonone’s approval is its potential to transform the way people experiencing post-partum depression are treated. Even better would be if its arrival brings more attention to perinatal health challenges more broadly — which have been fuelling an appalling increase in the US maternal mortality rate over the past 20 years.
Anyone who has given birth knows that the period after having a baby is one of enormous change. A new mom is grappling with suddenly being responsible for another human, at a time when all the relationships in her life — with her partner, parents and peers, and even her own body — have instantly shifted. It often feels extremely isolating. On top of that, health-care providers shift nearly all their focus from mother’s health to baby’s.
The post-partum period can be even tougher if the new parents lack housing stability, family leave or quality health care, says psychiatrist Elizabeth Fitelson, director of the Women’s Program in the psychiatry department of Columbia University Medical Center.
Until now, the medications for new mothers experiencing a mood and anxiety disorder have been underwhelming. A relative of zuralonone called Zulresso was the first treatment approved for post-partum depression in 2019, but its use has been limited by its delivery: A new mom has to stay in the hospital for nearly three days, separated from her family and baby, while the drug is given via continuous intravenous infusion. Conventional SSRIs are known to help, but their effects can take up to six weeks to kick in — an eternity for the parent of a newborn. And many new moms are frustrated with the side effects of those drugs.
Zuranolone’s benefit is to help patients feel better fast. The treatment course is just two weeks, sometimes working in a matter of days. And it’s a pill that can be taken at home. It does have some limitations: One is a black box warning from the FDA cautioning against driving or operating heavy machinery in the 12 hours after taking it, and the other is its potential cost compared with conventional, slower-acting drugs. Even so, “it really is a critical breakthrough,” Fitelson says. “I’m excited to have access to it for my patients.”
The invention of new treatments can also spur more diagnoses, something that’s sorely needed here. During pregnancy, most people interact regularly with the health-care system, which should create many opportunities for doctors to catch emotional challenges. But the reality is that women’s struggles are too often ignored. Less than 10% of women experiencing perinatal depression receive adequate treatment, said Kristina Deligiannidis, director of women’s behavioural health at Northwell Health’s Zucker Hillside Hospital.
“We need to improve screening, we need to improve access to care, and we need to improve the treatments that are available to women so they have choices,” says Deligiannidis, who helped lead the clinical trials of zuranolone in post-partum depression.
In recognition of that issue and in hopes of addressing the maternal mortality crisis, American College of Obstetricians and Gynecologists this summer updated its recommendations for screening and diagnosis of mental health conditions. To improve the chances of catching someone who is struggling, ACOG advocates screening women before pregnancy (during check-ups), during the first prenatal visit, later in the pregnancy and then during post-partum visits.
Zuranolone arrives on the heels of a cluster of other advances in women’s health this year. Last month, the FDA approved a test for pre-eclampsia, a surge in blood pressure during pregnancy that can be dangerous for both the mother and her baby. And in May, the FDA approved the first drug designed to address hot flashes in menopausal women.
“The reason zuranolone came about is in part because some researchers actually started paying attention to what women were saying,” Fitelson says. Fluctuating hormones are suspected to play a role in post-partum depression — and zuranolone mimics a derivative of the naturally occurring hormone progesterone.
The shift is welcome — and long overdue. Neuroscience has a long history of using male mice when studying new treatments for psychiatric and other brain disorders, in large part because they assumed that hormonal fluctuations related to the mouse version of a menstrual cycle would hinder their experiments. Similarly, women were largely left out of clinical trials during the period that SSRIs, the widely used antidepressants, were developed.
Zuranolone’s approval is yet another reminder that when researchers broaden their lens to include women’s health needs — and in general, women’s biology — the benefits can be profound. — Bloomberg
Lisa Jarvis is a columnist covering biotech, health care and the pharmaceutical industry