Health Canada has authorised Zurzuvae, the first medication in Canada specifically indicated to treat moderate or severe postpartum depression (PPD) in adults, Biogen Canada Inc. said.
Zurzuvae is a once-daily, 14-day oral treatment, according to Biogen. The company said clinical studies showed relief from depressive symptoms as early as day three, a significant reduction by day 15 and a sustained effect through day 45 compared with placebo.
Biogen said the drug takes a novel approach: instead of targeting serotonin pathways like traditional antidepressants, zuranolone modulates the brain’s gamma-aminobutyric acid A (GABAA) receptors, which the company said regulate mood affected by hormonal fluctuations after childbirth.
Dr. Crystal Clark, Canada Research Chair in Reproductive Mental Health at Women’s College Hospital, said the approval marks a major advance for maternal mental health.
“For postpartum individuals caring for a newborn while navigating major hormonal, physiological and life transitions, Zurzuvae offers a quick-acting option and new hope for improved outcomes,” she said.
Public-health researchers and maternal-mental-health organizations report that postpartum depression is a serious maternal mental-health issue that can begin during pregnancy or after childbirth.
The Vanier Institute of the Family and Statistics Canada have found that untreated PPD may impair daily functioning and disrupt bonding between mother and baby, potentially affecting infant sleep, feeding and long-term development.
Researchers also report the condition can contribute to longer-term mental-health challenges for both mother and child and increase stress within families.
Biogen said the Health Canada authorization is based on data from its NEST clinical-development program, including the Robin and Skylark studies. The company said both studies met their primary endpoint: a significant decline in depression scores, measured using the 17-item Hamilton Rating Scale for Depression, by day 15 compared with placebo.
According to Biogen, the Skylark study also showed symptoms improved as early as day three and remained improved through day 45. The company said Zurzuvae was generally well tolerated, with the most common side effects, at least 10 per cent, being somnolence, dizziness and sedation.
Eric Tse, general manager of Biogen Canada, said the approval addresses a “critical unmet need” for Canadian mothers.
“For the first time, mothers will have access to an effective treatment specifically indicated for PPD,” he said. He added the company is working with policymakers across Canada to enable timely access to the drug.
Biogen said Zurzuvae was approved in the United States in 2023, with clinical-trial data showing similar rapid and sustained symptom relief.
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