Camille Bains, Canadian Press
Published Thursday, August 17, 2023 8:33 EDT
Last Updated Thursday, August 17, 2023 8:33 EDT
The approval of a fast-acting, short-term treatment in the United States to treat postpartum depression has Canadian maternal health experts and advocates hopeful that people north of the border will soon have access to the same treatment.
Zuranolone is the first oral medication specifically designed for major postpartum depression, with relief starting on Day 3 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.
Drugmakers Biogen and Sage Therapeutics received approval from the US Food and Drug Administration for the new treatment, which is being marketed under the brand name Zurzuvae, earlier this month.
A spokesperson for Biogen said the company is focused on making the pill commercially available in the US later this year and has not submitted an application for approval from Health Canada.
However, “Biogen continues to explore opportunities to bring Zurzuvae to patients outside the US,” it said in an email response.
Maternal health and childbirth-related deaths have received increasing attention in recent years. But there are still gaps in supporting people trying to overcome the deep despair of postpartum depression, which is believed to be partly related to hormonal changes that trigger emotional responses far beyond the “baby blues,” which do not require medical treatment.
Currently only one drug, launched in 2019 by Sage, targets postpartum depression. Zulresso is approved in the US and is administered intravenously in a medical facility over 60 hours, and costs US$34,000.
The price of zuranolone has not been set, said a spokesperson for Biogen.
The drug was approved after the results of a randomized controlled clinical trial of nearly 200 people with severe postpartum depression showed significant improvements in symptoms such as suicidal ideation, anxiety and insomnia.
Participants in the study, which was published last month in the American Journal of Psychiatry, were given either 50 milligrams of zuranolone or a placebo pill per day for two weeks.
“Treatment with zuranolone compared with placebo resulted in a statistically significant improvement in depressive symptoms on Day 15,” said the study, which involved multiple sites and was led by a behavioral scientist at New York-based Feinstein Institutes of Medical Research.
Improvement in symptoms lasted 45 days after the first dose, the study said. A previous trial, published in JAMA Psychiatry in 2021, showed that a 30-milligram dose of zuranolone also provided symptom relief over the same period.
Statistics Canada’s 2019 report on maternal mental health said nearly a quarter of people who gave birth between January and June 2018 had feelings consistent with postpartum depression or an anxiety disorder. The proportion of respondents reporting the condition varied across provinces, ranging from 16 percent in Saskatchewan to 31 percent in Nova Scotia.
The findings are 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 are slow acting and are often used indefinitely.
Zuranolone is believed to target the brain’s GABA receptors, which are part of the main signaling pathway responsible for stress and mood regulation. In doing so, it compensates for decreased levels of natural neurosteroids that protect the brains of pregnant people and their fetuses from stress during pregnancy.
Carole Dagher said she couldn’t leave the house for months after her daughter’s birth in 2010 because she was lost in thoughts of being an “incompetent mother” and repeatedly considered suicide while trying to bond with her baby.
“I felt completely isolated, even though my mother and sister came to help,” said the Toronto attorney, who also feels guilty about not being able to breastfeed.
After her husband insisted that she see their family doctor, Dagher was immediately referred to a mental health doctor at Mount Sinai Hospital, where she gave birth.
However, she was reluctant to try antidepressants because she was afraid of “poisoning” her baby with the pumped milk. Her only other option was to be hospitalized immediately, something she also declined because she was worried about leaving her daughter at home.
“I tried several antidepressants until I found one that worked well enough for me,” Dagher said of the frustrating months-long process while also seeing a psychiatrist.
She hopes that if the drug maker submits an application to Health Canada, it will be approved soon so that women and their families do not have to suffer too long.
Those most at risk for postpartum depression have a history of mental illness.
Dagher was born in Lebanon in 1977, soon after the start of the civil war that kept his family in bomb shelters for seven years. They moved to Canada when he was 13 years old.
She said much of the trauma she experienced as a child resurfaced after her daughter was born, contributing to the postpartum depression she also experienced after the birth of her second daughter in 2014, even though by then she had accepted that medication would be a “lifesaver.”
Dr Diane Francoeur, CEO of the Society of Obstetricians and Gynecologists of Canada, said zuranolone would provide reassurance to women who may be afraid to take their existing antidepressants for a long time, but any drug should be used in combination with psychotherapy for severe postpartum depression.
“I think we should really be aware that depression can kill women. So, to have a new drug, it’s a celebration, especially if it actually kicks into action on Day 3,” she said.
“There is a cost for the baby’s development, so we have to make sure that it will be available in Canada as soon as possible, we hope.”
Daisy Singla, a clinical psychologist and professor of psychiatry at the University of Toronto, says that while breakthrough drugs seem promising, “talk therapy” is a proven part of treatment for postpartum depression.
However, most therapies are inaccessible due to high costs and long waiting times, said Singla, also a senior scientist at the Center for Addiction and Mental Health in Toronto.
Singla led a US-funded study of more than 1,200 patients from Toronto, Chicago and Chapel Hill, NC, to compare how they received counseling from laypeople, 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 already be seeing a psychotherapist, Singla said.
Some of those providing therapy are referred by community groups and selected for skills including empathy and collaboration before they receive three to five days of training to help patients learn new coping skills. Sessions are supervised by a specialist.
The trial, which started in early 2020, is also comparing online appointments versus in-person therapy for those who may face challenges with child care or transportation.
This includes women who are still pregnant because postpartum depression can start before a person gives birth.
If you or someone you know is having suicidal thoughts, support is available 24/7 by calling Talk Suicide Canada (1-833-456-4566) or texting 45645 in the evening. Quebec residents can call 1-866-APPELLE (1-866-277-3553) or visit suicide.ca for support via text and online chat.
This report by The Canadian Press was first published on August 17, 2023.
Canadian Press’ health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
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