Health Canada has approved the first drug designed to treat postpartum depression.
Zuranolone, sold under the brand name Zurzuvae, is a pill taken once a day for 14 days and can start relieving symptoms of depression in as little as three days.
The drug, made by Biogen, is approved for use in the United States starting in late 2023, and has also been approved in the United Kingdom and the European Union.
According to Health Canada's website, one in five women experience depression or anxiety during or after pregnancy.
Zuranolone is a welcome drug for women suffering from moderate to severe postpartum depression, said Dr. Crystal Clark, a psychiatrist and Canada Research Chair in Reproductive Mental Health at Women's College Hospital in Toronto.
Antidepressants, which are selective serotonin reuptake inhibitors, are often used to treat postpartum depression, Clark said, but they generally don't work very quickly and women have to take them for quite a long time.
“While there are effective treatment options for many patients with postpartum depression, this is the first drug that can be taken for two weeks and cause rapid onset within days.”
SSRI antidepressants make the neurotransmitter serotonin more available in areas of the brain associated with mood.
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Zuranolone is a synthetic version of allopregnanolone, a metabolite of progesterone, a hormone that fluctuates with pregnancy. This drug acts on gamma-aminobutyric acid receptors in the brain, which are involved in regulating mood.
Hormonal changes have been linked to the onset of symptoms of postpartum depression, Clark said.
The drug is recommended for moderate to severe postpartum depression, with severity determined by the level of impairment in daily functioning, Clark said.
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Symptoms include depressed mood or severe mood swings, severe anxiety or panic attacks, intense irritability or anger, feelings of worthlessness, shame or guilt, difficulty bonding with the baby, and overwhelming fatigue beyond the lack of sleep that new parents typically face.
A mother with postpartum depression may have a change in appetite, difficulty getting out of bed, showering, or getting dressed, even if she is caring for her baby.
According to Clark, in severe cases, people may feel like they don't want to live.
Many of her patients with postpartum depression are “shocked that something is wrong with them.”
“Some of the comments I hear are, 'I mean, I wanted to get pregnant and I'm looking forward to having a baby, so I don't understand why I feel so bad,'” she said.
Health Canada said in an email to The Canadian Press that it had “thoroughly reviewed” Biogen's evidence proving that “this drug meets all standards of safety, efficacy and quality and that, when used as intended, its benefits outweigh the risks.”
Part of that evidence is a clinical trial that used the Hamilton Depression Rating Scale to measure changes in symptoms in 196 women with severe postpartum depression. They were randomly assigned to take either Zuranolone or a placebo pill once a day for 14 days.
The study found a “significant improvement” in depression symptoms in people who took the drug. The first measurements were taken after two weeks of treatment, but some women's symptoms improved within three days of starting treatment.
The researchers followed up the study participants after 45 days and found that their symptoms remained reduced.
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It's unclear how long these effects last or whether symptoms of depression return beyond that time, but patients in the United States are “making good progress” with the drug, Clark said.
The most common side effects among study participants taking Zuranolone were drowsiness, dizziness, sedation, and headache.
Clark said women should not breastfeed while taking the drug until further research is done to determine whether it is safe for babies.
Because of potential drowsiness, it's a good idea to have someone with you to help care for your baby for the first few days until you know how your baby will react to the medication, she says.
Dr. David Silver, a gynecological psychiatrist at UPMC in Camp Hill, Pennsylvania, has been prescribing Zuranolone for more than a year and said it is a “very important addition” to the treatment arsenal for postpartum depression because of its fast-acting properties.
“When you have a woman caring for a newborn immediately after birth, time is of the essence,” he said.
Silver said he is looking at patients' patterns of depression to determine whether SSRI antidepressants or zuranolone are the best treatments.
“If you've had multiple episodes of depression in the past and the depression has continued throughout your pregnancy… (and) it didn't just start in late pregnancy or postpartum, then you may benefit from SSRIs,” she said.
“On the other hand, if someone who hasn't been depressed throughout their pregnancy suddenly develops these noticeable symptoms late in pregnancy or soon after giving birth, that's the person to me that I'm really thinking about on Zuranolone.”
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