Health Canada approves first drug specifically made to treat moderate to severe postpartum depression

Health Canada has approved the first drug specifically developed to treat moderate to severe postpartum depression, a condition affecting roughly one in five women in Canada.

ZURZUVAE, also known as zuranoline, is a 14-day treatment that helps the brain restore its natural balance between calming and activating signals.

Clinical trials have reported to show improvements as early as day three, a significant reduction in symptoms by day 15 and a sustained effect by day 45, in contrast to a placebo.

Patients with ZURZUVAE showed an average reduction of 17.8 points while those with a placebo showed an average reduction of 13.2 points in the 17-item Hamilton Rating Scale , both in day 15 of treatment.

Postpartum depression is the most common complication in childbirth, with symptoms including depressed mood, anxiety, functional impairment of daily activities and even thoughts of self-harm or harm to the infant, according to a press release from the drugmaker Biogen .

Postpartum depression can also have effects on families and societies, being a cause for lower marital satisfaction, higher levels of stress among partners and higher rates for divorce or separation.

“A treatment developed specifically for postpartum depression marks an important step forward for maternal mental health,” said Dr. Crystal Clark, a Canada Research Chair in reproductive mental health at the University of Toronto, in a statement to Biogen. “Postpartum depression is often driven by profound hormonal shifts that occur during and after childbirth … therapy designed to address the impact of these biological changes on mental health addresses a longstanding gap in medical care.”

Side effects include dizziness (13 per cent of participants), sedation (10 per cent of participants) and sleepiness (28 per cent of participants).

“There isn’t long-term data available, so it is important for patients to be informed early by health professionals about potential side effects to monitor them,” said Frey. “Mild and moderate symptoms are manageable, however those experiencing severe levels of sedation and drowsiness might need to stop the treatment and look at traditional solutions.”

ZURZUVAE was approved by the Food and Drug Administration in the United States in August 2023. The United Kingdom and European Commission approved it in August and September this year, respectively.

General manager Eric Tse sees the approval of ZURZUVAE as a significant advancement for maternal mental health, providing the first treatment specifically designated towards postpartum depression.

“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,” Eric Tse, Biogen Canada’s general manager, said in a press release. “To any mother experiencing postpartum depression, prompt symptom relief and return to more normal functioning is critical. For the first time, mothers will have access to effective treatment, specifically indicated for PPD.”

Dr. Benico Frey, a psychiatry and neuroscience professor at McMaster University, said in an interview, it’s not known if there are risks associated with breastfeeding.

“Among mothers who prefer to breastfeed, most will likely be reluctant to use this medication and may lean towards avoiding it while breastfeeding,” said Frey in an interview. “Some may still choose to breastfeed however there is no safety data in place.”

The only available data of breastfeeding women on ZURZUVAE, is from a clinical trial in 2024, that examined 14 participants. Results showed that ZURZUVAE transfers into human breast milk at low levels(0.983 per cent), however Biogen said the effects to breastfed infants is unknown and advises women to discontinue breastfeeding while taking ZURZUVAE.

Dr. Ryan Van Lieshout, a perinatal psychiatrist at McMaster University told the National Post the rollout of ZURZUVAE as a step forward, however wants Canada to improve the quality of psychotherapy so prescriptions can be a last resort.

According to the Canadian Institute of Health , one in 10 Canadians must wait four or more months before receiving community mental health counselling.

“Other barriers include a lack of trained providers for psychotherapies, such as cognitive behavioural therapy and interpersonal psychotherapy, which are often the first treatment,” said Van Lieshout. “Combined with stigma, these gaps, particularly in therapies preferred by pregnant or breastfeeding patients, make it harder to access care.”

It’s not yet known if ZURZUVAE will be covered by provincial health plans.

“The medication still has not had a price set in Canada yet, all we know is for a two week course in the U.S. (it) is $15,000, which will certainly affect access,” said Van Lieshout. “How provincial funders and insurance companies choose to cover it will determine availability and I suspect a high price tag will have a significant effect.”

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