Health Canada has authorized a new drug to treat postpartum depression.
The regulator says zuranolone, a pill sold under the brand name Zurzuvae, is authorized in Canada to relieve symptoms of moderate or severe depression after childbirth.
“This is the first drug authorized in Canada for this purpose,” Health Canada said in a statement to CBC News on Tuesday.
The medication is recommended for moderate to severe postpartum depression, with severity measured by the level of impairment in daily functioning.
Biogen, the drug’s developer, says zuranolone is to be taken once a day for 14 days and will be available in Canada early in 2026, but governments and insurers would still need to determine coverage.
Health Canada said in an email it has done a “thorough review” of Biogen’s evidence demonstrating “that the drug meets all criteria for safety, effectiveness and quality, and that its benefits outweigh its risks when used as intended.”
The drug has also been authorized in the U.S., the U.K. and the European Union.
Dr. Ryan Van Lieshout, a psychiatry professor at McMaster University who wrote about the hope and hype surrounding the medication in 2023 when it was approved for use in the United States, told CBC News he hopes the drug’s approval sheds light on the topic of postpartum depression.
“Hopefully, it reduces some self blame that people might have around why did I develop this?” said Van Lieshout, who was not involved in the studies. “There’s a biological contributor to it, it’s treatable.”
Symptoms of postpartum depression can include depressed mood or severe mood swings, severe anxiety or panic attacks, intense irritability and anger, feelings of worthlessness, shame or guilt, difficulty bonding with the baby and overwhelming fatigue beyond the sleep deprivation new parents normally face.
About one-quarter (23 per cent) of mothers who recently gave birth reported symptoms consistent with postpartum depression or an anxiety disorder, according to Statistics Canada.
Unlike typical antidepressants that can take time to have an effect, zuranolone works faster and typically is taken for just 14 days, Van Lieshout said.
In a randomized clinical trial of zuranolone compared with a placebo, by day 15, about 27 per cent of participants showed no depressive symptoms.
In some participants, improvement was seen as early as the third day of treatment, and lasted throughout the 45 day study.
Kara Fiscus, 37, of Sacremento, Calif., gave birth in May 2023. She was breastfeeding her son, but in September of that year, she recognized that he wasn’t getting enough to eat. Fiscus started pumping breast milk for a month and says that’s when she felt the onset of postpartum depression.
Fiscus says she was “obsessively thinking about how I could get away with killing myself in the bathroom.” She was eventually hospitalized and prescribed zuranolone.
“By day three, I remember saying to my husband, ‘It’s been at least 20 minutes since I thought about killing myself,’ ” she said. “And that was a very big deal. It was all I thought about for months.”
How the drug is thought to work
Researchers say zuranolone works differently than SSRI antidepressants, which make the neurotransmitter serotonin more available to areas in the brain associated with mood.
Zuranolone is a synthetic version of allopregnanolone — a metabolite of the hormone progesterone, which fluctuates during pregnancy, said Dr. Kristina Deligiannidis, a psychiatrist and researcher at Zucker Hillside Hospital in New York. Deligiannidis conducted randomized clinical trials on zuranolone. She published a paper in the American Journal of Psychiatry in 2023.
The medication is a neurosteroid that acts on gamma-aminobutyric acid receptors in the brain that help regulate mood, said Deligiannidis. In animal studies, zuranolone has been shown to help maintain healthy brain function during stress, she said.
Deligiannidis saw this for herself during the clinical trials. On the third day of taking the medication, she said some of the participants who’d previously been severely depressed described a veil lifting, and she said they were suddenly making plans with their babies.
“What needs to happen next is to try and understand exactly how these neurosteroids are so rapidly restoring brain function to manage stress in the brain,” Deligiannidis said.
Zuranolone was just approved in the U.S. to treat the condition, which is known to affect one in five new mothers. UBC’s Dr. Melissa Lem weighs in.
Deligiannidis noted 57 per cent of participants in the zuranolone group improved by as much as 50 per cent, while just under 39 per cent of those in the placebo group saw the same level of improvement.
About 27 per cent in the zuranolone group had no symptoms or were considered in remission at day 15, compared with nearly 17 per cent in the placebo group.
It’s not known how long those effects will last or if there were any recurrences of depressive symptoms after the study period.
Side-effects for driving
Van Lieshout did note some drawbacks to the medication, including that it can’t be taken during pregnancy, that it is not recommended while breastfeeding and that up to 30 per cent of those who take it experience significant sleepiness.
“That’s led the manufacturer of the medication to say that people shouldn’t drive within 12 hours of taking it,” he said.
The company hasn’t yet released the price of the drug in Canada. In the U.S., the wholesale price was $15,900 US for a 14-day treatment cycle.
Treatment not 1 size fits all
Dr. Crystal Clark, an associate professor of psychiatry at the University of Toronto and associate head of research at Women’s College Hospital, welcomed the addition of the medication to the other treatment options, but cautioned that one size does not fit all.
She said treatment would be “tailored to that individual.”
While one person might feel slightly drowsy on zuranolone, she said, another might not be able to rouse to feed a baby.
Clark, who has consulted for Biogen, likened the medication to taking a short course of antibiotics, compared with other antidepressants that tend to be taken longer term.
All of the physicians stressed that psychotherapy remains the first line treatment for depression.
If you or someone you know is struggling, here’s where to look for help:
