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news.Biogen has received a notice of compliance (NOC) from Health Canada for Zurzuvae (zuranolone), a neuroactive steroid (NAS), as a treatment for moderate or severe postpartum depression (PPD) in women.
The once-daily oral therapy is intended for the treatment of PPD. Credit: Iryna Imago/Shutterstock.com.
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The once-daily oral therapy is administered as a 14-day course. Clinical trials demonstrated benefits from as early as day three, with significant symptom reduction by day 15, and effects maintained through day 45 against placebo.
Unlike traditional antidepressants that target serotonin pathways, Zurzuvae is designed to modulate the gamma-aminobutyric acid A (GABAA) brain receptors’ activity, addressing mood regulation.
Health Canada’s decision is informed by the NEST clinical programme, which includes the SKYLARK and ROBIN studies. Both trials achieved their primary endpoint with a significant decrease in the Hamilton Rating Scale for Depression (HAMD-17) score at day 15 versus placebo.
SKYLARK reported a decrease in depressive symptoms as early as day three, maintained through day 45.
Zurzuvae was generally well-tolerated, with the most common side effects being sedation, somnolence and dizziness.
Biogen Canada general manager Eric Tse stated: “This approval addresses a critical unmet need for Canadian mothers, marking an important step in elevating how we treat what can be a devastating maternal health issue.
“For the first time, mothers will have access to effective treatment, specifically indicated for PPD. This innovation builds on Biogen’s proven history of pioneering first-in-class treatments for unmet medical needs, and we are working collaboratively with decision-makers across Canada to enable timely access to Zurzuvae.”
Zurzuvae is also available in the European Union, UK and US, following earlier regulatory approvals.
