Medication approved by Health Canada to treat postpartum depression
Health Canada has authorized a new drug to treat postpartum depression.
regulator says zUranolone, a pill sold under the brand name Zurzuve, is authorized in Canada to relieve symptoms of moderate or severe depression after childbirth.
“it is First The drug is 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, the severity of which is 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 as early as 2026, but governments and insurers will still require itDetermine coverage.
Health Canada said in an email that it had conducted a “thorough review” of Biogen’s evidence, which showed “this drug meets all criteria for safety, effectiveness and quality, and its benefits outweigh its risks when used as intended.”
This medicine has also been authorized in the US, UK and the European Union.
Dr. Ryan Van Lieshout, A psychiatry The McMaster University professor, who wrote about the hope and hype surrounding the drug in 2023 when it was approved for use in the United States, told CBC News that he hopes the drug’s approval will shed light on the topic of postpartum depression.
“Hopefully, this will reduce some of the self-blame that people have around me as to why did I develop this?” Said van leeshOutside, who was not involved in the study. “There is a biological contributor to this, it is treatable.”
Symptoms of postpartum depression can include depressed mood or severe mood changes, severe anxiety or panic attacks, intense irritability and anger, feelings of worthlessness, shame or guilt, difficulty bonding with the baby, and extreme fatigue beyond the lack of sleep that new parents typically face.
About this a quarter According to Statistics Canada, 23 percent of mothers who have recently given birth reported symptoms of postpartum depression or anxiety disorder.
Van Lieshout said that unlike typical antidepressants, which can take time to take effect, zuranolone works quickly and is usually taken for only 14 days.
In a randomized clinical trial of zuranolone compared with placebo, about 27 percent of participants had no depressive symptoms by day 15.
In some participants, improvements were seen as early as the third day of treatment and continued throughout the 45-day study.
Kara Fiscus, 37, of Sacramento, California, gave birth to a child in May 2023. She was breastfeeding her son, but in September of that year she discovered that she was not getting enough food. Fiscus began expressing breast milk for a month and says that’s when she felt the beginnings of postpartum depression.
Fiscus says she was “obsessed with how I could get away with killing myself in the bathroom.” She was eventually hospitalized and prescribed zuranolone.
“By the third day, I remember saying to my husband, ‘It’s been at least 20 minutes since I’ve been thinking about killing myself,'” she said. “And it was a big deal. I’d thought about it for months.”
How the drug is believed to work
Researchers say zuranolone works differently than SSRI antidepressants, making the neurotransmitter serotonin more available in brain areas associated with mood.
Zuranolone is a synthetic version of allopregnanolone — a metabolite of the hormone progesterone, which fluctuates during pregnancy, said Dr. Christina Deligiannidis, a psychiatrist and researcher at Zucker Hillside Hospital in New York. Deligiannidis conducted randomized clinical trials on zuranolone. He published a paper in American Journal of Psychiatry In 2023.
The drug is a neurosteroid that acts on gamma-aminobutyric acid receptors in the brain that help regulate mood, Deligiannidis said. Animal studies have shown zuranolone to help maintain healthy brain functioning during stress, he said.
Deligiannidis observed this himself during clinical trials. On the third day of taking the drug, he said some participants who had previously been severely depressed described lifting the veil, and they said they were suddenly making plans with their children.
“What needs to be done next is to try to understand how these neurosteroids are restoring brain function so rapidly to manage stress in the brain,” Deligiannidis said.
Zyuranolone was recently approved in the US to treat this condition, which is known to affect one in five new mothers. UBC’s Dr. Melissa Lamm has an idea.
Deligiannidis noted 57 percent of those who participated zuranolone group Up to 50 percent improved, while less than 39 percent of people in the placebo group saw the same level of improvement.
About 27 percent in the zuranolone group had no symptoms or were considered in remission at day 15, compared with about 17 percent in the placebo group.
It is not known how long these effects would last or whether depressive symptoms recurred after the study period.
side effects of driving
van liehowt did Note some shortcomings Side effects of the drug include that it cannot be taken during pregnancy, it is not recommended during breastfeeding and up to 30 percent of those who take it experience significant sleepiness.
“This has led the drug’s manufacturer to say that people should not drive within 12 hours of taking it,” he said.
The company has not yet released the price of the drug in Canada. In the US, the wholesale price for a 14-day treatment cycle was $15,900 US.
Treatment is not one size fits all
Dr. Crystal Clark, associate professor of psychiatry at the University of Toronto and associate head of research at Women’s College Hospital, welcomed the addition of the drug to other treatment options, but cautioned that one size does not fit all.
He said treatment would be “tailored to that individual.”
While one person may feel a little sleepy while taking zuranolone, another person may not be able to wake up to feed the baby, he said.
Clark, who has consulted for Biogen, compared the drug to taking a short course of antibiotics, compared to other antidepressants that are taken for a longer period of time.
All physicians emphasized that psychotherapy is the first-line treatment for depression.
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