The approval of a fast-acting, short-term medication in the United States to treat postpartum depression has Canadian maternal health experts and advocates hoping people north of the border will soon have access to the same treatment.
Zuranolone is the first oral drug specifically designed for severe depression after childbirth, with relief that starts on day three of a two-week regimen, according to clinical trial results. Standard antidepressants can take up to three months to show mood improvement in women whose symptoms may include thoughts of harming themselves or their baby.
Drug manufacturers Biogen and Sage Therapeutics received approval from the U.S. Food and Drug Administration for the novel medication, marketed under the brand name Zurzuvae, earlier this month.
A spokeswoman for Biogen said the companies are focusing on making the pill commercially available in the U.S. later this year and have not filed an application seeking approval from Health Canada.
However, “Biogen continues to explore opportunities to bring Zurzuvae to patients outside the U.S.,” she said in an emailed response.
Maternal health and mortality related to childbirth have slowly gained more attention in recent years. But gaps remain in supporting people trying to cope with the deep despair of postpartum depression, believed to be partly linked to hormonal changes that trigger an emotional response far beyond the “baby blues,” for which medical treatment is not needed.
Currently, only one drug, launched in 2019 by Sage, targets postpartum depression. Zulresso is approved in the U.S. and given intravenously in a medical facility for 60 hours, at a cost of US$34,000.
A price for zuranolone has not yet been set, the Biogen spokeswoman said.
The drug was approved after the results of a randomized controlled clinical trial of nearly 200 people with severe postpartum depression showed significant improvement in symptoms such as suicidal ideation, anxiety and insomnia.
Participants in the study, published last month in the American Journal of Psychiatry, were given 50 milligrams per day of zuranolone or a placebo pill for two weeks.
“Treatment with zuranolone compared with placebo resulted in statistically significant improvement in depressive symptoms at day 15,” says the study, which involved multiple sites and was led by a behavioural scientist at the New York-based Feinstein Institutes of Medical Research.
Improvement in symptoms lasted for 45 days after the first dose, the study says. An earlier trial, published in JAMA Psychiatry in 2021, showed that a 30-milligram dose of zuranolone also alleviated symptoms through the same period.
A 2019 Statistics Canada report on maternal mental health said almost one-quarter of people who gave birth between January and June 2018 had feelings consistent with either postpartum depression or an anxiety disorder. The proportion of respondents reporting those conditions varied across provinces, ranging from 16 per cent in Saskatchewan to 31 per cent in Nova Scotia.
The findings were based on a survey in collaboration with Health Canada and the Public Health Agency of Canada, and participants were surveyed five to 13 months after giving birth.
Postpartum depression has been treated with antidepressants called selective serotonin reuptake inhibitors such as Prozac, but they’re slow to act and are often taken indefinitely.
Zuranolone is believed to target the brain’s GABA receptors, which are part of a major signalling pathway responsible for stress and mood regulation. In doing so, it compensates for reduced levels of a naturally occurring neurosteroid that protects the brains of pregnant people and their fetuses from stress during pregnancy.
Carole Dagher said she could not leave the house for months after the birth of her daughter in 2010 as she became consumed with thoughts of being an “incompetent mother” and repeatedly considered suicide while trying to bond with her baby.
“I just felt completely isolated, even though I had my mom and my sisters coming to help,” said the Toronto lawyer, who was also overwhelmed by the guilt of not being able to breastfeed.
After her husband insisted she see their family doctor, Dagher was referred urgently to a mental health clinician at Mount Sinai Hospital, where she’d given birth.
However, she was reluctant to try antidepressants because she feared “poisoning” her baby with her pumped breast milk. Her only other option was being admitted to the hospital right away, something she also resisted as she worried about abandoning her daughter at home.
“I tried multiple antidepressants until I found one that somewhat worked for me,” Dagher said of the frustrating, months-long process while she also saw a psychiatrist.
She’s hoping that if the drug makers file an application to Health Canada, it will quickly be approved so women and their families do not have to suffer for so long.
Those who are most at risk of postpartum depression have a history of mental illness.
Dagher was born in Lebanon in 1977, soon after the start of a civil war that had her family living in a bomb shelter for seven years. They moved to Canada when she was 13.
She said much of the trauma she endured as a child resurfaced after her daughter was born, contributing to the postpartum depression that she also experienced following the birth of a second daughter in 2014, though by then she’d accepted that medication would be a “lifesaver.”
Dr. Diane Francoeur, CEO of the Society of Obstetricians and Gynaecologists of Canada, said zuranolone will give some assurance to women who may fear prolonged use of existing antidepressants, but any drug should be used in combination with psychotherapy for severe postpartum depression.
“I think that we need to be really aware that depression could kill women. So, to have a new drug, it’s a celebration, especially if it really does act on day three,” she said.
“There’s a cost on the baby’s development, so we have to make sure that it’s going to be available in Canada ASAP, we hope.”
Daisy Singla, a clinical psychologist and associate professor of psychiatry at the University of Toronto, said that while the breakthrough drug seems promising, “talk therapy” is a proven part of treatment for postpartum depression.
However, most therapy is inaccessible because of the high cost and the long wait times, said Singla, also a senior scientist at the Centre for Addiction and Mental Health in Toronto.
Singla is leading a U.S.-funded study of more than 1,200 patients from Toronto, Chicago and Chapel Hill, N.C., to compare how they fare from getting counselling from lay people, as well as nurses, midwives and doulas, compared to mental health specialists.
Patients get one-hour sessions for eight weeks and some are also on medication for severe postpartum depression and may have already seen a psychotherapist, Singla said.
Some of those providing therapy are referred by community groups and chosen for skills including empathy and collaboration before they get three to five days of training to help patients learn new coping skills. Sessions are supervised by a specialist.
The trial, which began in early 2020, is also comparing online appointments versus in-person therapy for those who may face challenges with child care or transportation.
It includes women who are still pregnant because postpartum depression can start before someone gives birth.
If you or someone you know is thinking about suicide, support is available 24/7 by calling Talk Suicide Canada (1-833-456-4566) or texting 45645 in the evenings. Residents of Quebec can call 1-866-APPELLE (1-866-277-3553) or visit suicide.ca for support by text and online chat.