The landmark approval of the first pill for postpartum depression offers an important new treatment for the one in seven new mothers who experience postpartum depression. Suicide is a leading cause of maternal mortality in the US. Yet on its own, the new drug — promising as it is — is not enough, considering that as many as half of women with postpartum depression are 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 Inc and Sage Therapeutics Inc, will be marketed as Zurzuvae. The most obvious upside of zuranolone’s approval is its potential to transform the way people experiencing postpartum depression are treated. Its arrival could potentially bring more attention to perinatal health challenges more broadly — which have been fueling an appalling increase in the US maternal mortality rate over the last 20 years.
Illustration: Mountain People
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, healthcare providers shift nearly all their focus from mother’s health to baby’s. The postpartum period can be even tougher if the new parents lack housing stability, family leave or quality healthcare, said 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 zuranolone called Zulresso was the first treatment approved for postpartum depression in 2019, but usage 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. While conventional antidepressant drugs such as SSRIs are known to help, their effects still take up to six weeks to kick in. This is a long time for the mother of a newborn, who would also be feeling 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. Furthermore, it is a pill that can be taken at home.
Yet it does have some limitations. One is a black box warning from the US Food and Drug Administration 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 said. “I’m excited to have access to it for my patients.”
The invention of new treatments can also spur more diagnoses, something that is sorely needed here. During pregnancy, most people interact regularly with the healthcare system, which should create many opportunities for doctors to catch emotional challenges.
However, the reality is that women’s struggles are too often ignored. Less than 10 percent of women experiencing perinatal depression receive adequate treatment, said Kristina Deligiannidis, director of women’s behavioral 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,” said Deligiannidis, who helped lead the clinical trials of zuranolone in postpartum depression.
In recognition of that issue and in hopes of addressing the maternal mortality crisis, American College of Obstetricians and Gynecologists (ACOG) 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 during pre-pregnancy checkups, during the first prenatal visit, later in the pregnancy and then during postpartum 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. 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 said.
Fluctuating hormones are suspected to play a role in postpartum 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, but changed approach 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 the benefits can be profound.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, healthcare and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News. This column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.
RSS