A new pill in the U.S. offers hope to mothers with postpartum depression
Zuranolone was approved by the FDA on Aug. 4. Its manufacturers have yet to ask Health Canada for approval
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Amy Bingham had struggled with depression for years, but had never heard about postpartum depression. When she had her first child Benjamin in 2018, she was overwhelmed with anxiety and insomnia, and had a hard time bonding with him.
"Everything was just a lot more powerful and a lot darker than I thought it would be," she told The Current guest host Anthony Germain.
It took a long time for the new mom from Burlington, N.C., to share how she was feeling because she didn't want to be seen as an "unfit mother." After finally confiding in a friend and learning about postpartum depression, she decided to enrol in a clinical trial for zuranolone, a new medication that might help her symptoms.
Within days of participating in the trial, Bingham was sleeping better, relaxing more and connecting with her son.
Zuranolone, which will be marketed under the brand name Zurzuvae, was approved by the FDA on Aug. 4. It's the first pill developed specifically to treat postpartum depression — and maternal mental health experts say it has the potential to completely transform how the condition is treated.
The oral capsule is designed to be taken once a day for only two weeks. Phase 3 clinical trial results showed doses of both 30 and 50 milligrams led to the rapid reduction of depression symptoms in as little as three days. In the trial, 153 of the 275 participants were randomized — meaning some received a placebo instead of zuranolone.
The neuroactive steroid antidepressant works on the stress management centres in the brain and is much faster than serotonin-based medicines, according to Dr. Kristina Deligiannidis, a reproductive psychiatrist and the principal investigator of the study.
"This really changes the way we can treat postpartum depression because it gives us a tool to rapidly bring down the depressive symptoms for women and get them feeling like themselves again," she said.
"It's a rapid onset and short treatment course that's completely different [from] whatever else we have on the market for postpartum depression or major depression used off-label, outside of brexanolone which is given as a 60-hour infusion."
Deligiannidis said she gets goosebumps when she thinks about all the women who will be helped with this study.
"You know, when the mother-in-law comes in or the patient's mother comes in and the baby's grandmother says, 'Oh, my gosh, my daughter's back.' That's what we're doing to transform lives. And that's why these developments and this research is so critical," she said.
Many conditions that occur exclusively in females or are more prevalent in females have been, on average, less studied in medicine.- Dr. Kristina Deligiannidis, reproductive psychiatrist
Zuranolone comes with potential side effects including sleepiness, dizziness, diarrhea and fatigue. Deligiannidis said there's always the option to lower the dose if the patient is too uncomfortable.
Women who participated in the study were not permitted to give breast milk to their infants, she said, because more data is required to know whether or not it's safe. Instead, patients were supported with breast pumps and donor milk.
Canadian approval
Zuranalone was developed by Sage Therapeutics and produced in partnership with Biogen Inc., two Massachusetts-based companies. They have not yet applied to Health Canada to approve its use here, but the pill is generating interest in the Canadian medical community.
"It's very exciting and promising," said Dr. Tuong Vi Nguyen, a reproductive psychiatrist at the McGill University Health Centre in Montreal.
Hear more from Dr. Tuong Vi Nguyen on Day 6:
Nguyen said zuranolone is not a standalone solution, and should complement rather than replace other postpartum depression treatments.
Should the drug become available in Canada, she said she is open to prescribing it but will advise her patients to continue other treatments such as individual psychotherapy, couples therapy, family therapy or standard antidepressants.
"I think the best approach is multimodal," she said.
Paradigm shift
Nguyen says women with a personal or family history of depression, anxiety or any mental disorder related to hormonal changes could have a predisposition to postpartum depression. Since the start of the pandemic, she estimates as many as one in three new moms in Canada suffer from significant depressive and anxious symptoms after delivery.
Despite how many women are affected, however, very little effective treatment exists.
Deligiannidis said postpartum depression has been largely understudied for far too long.
"Unfortunately, many conditions that occur exclusively in females or are more prevalent in females have been, on average, less studied in medicine," she said.
She hopes the positive results of this new study springboard more research and treatment, and encourage more women to seek help.
"There's a lot of excitement in the field about these active steroid antidepressants and what they can do, but I think that we're just at the beginning … of a whole different treatment paradigm," she said.
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Audio produced by Juliana Konrad and Arielle Piat-Sauvé