Zulresso: All About The New Postpartum Depression Drug
Approved to treat postpartum depression, Zulresso is a breakthrough in maternal mental health. Yet the drug’s cost and accessibility may make it off-limits to some women. Here's what you need to know.
In March 2019, the U.S. Food and Drug Administration (FDA) approved Zulresso—the first drug targeting postpartum depression. Women’s health professionals applauded this breakthrough in mental health treatment, but they also raised concerns about its cost and accessibility. Here’s everything you need to know.
What is Zulresso?
Affecting one in nine new mothers, postpartum depression (PPD) transcends the "baby blues." It typically lasts longer than two weeks, and symptoms can worsen (and even endanger) the lives of mothers and babies. Doctors typically treat PPD with counseling and antidepressants, but mothers may need to cycle through several medications to find one that's effective. Relief—if it comes—may not appear for four to six weeks. That’s why Zulresso is a breakthrough for sufferers everywhere.
Zulresso (brexanolone) is manufactured by Sage Therapeutics. It’s an intravenous infusion that must be given continuously over 60 hours (2.5 days). Protocol requires a patient's admission to a perinatal inpatient unit that allows careful monitoring. Clinical trials showed that Zulresso starts working in hours, and the positive effects still existed 30 days later.
Common side effects of Zulresso include dry mouth, sleepiness, and flushing. More severe side effects also exist, such as sudden loss of consciousness or excessive sedation, according to Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press announcement in March 2019. The medication might also interfere with breastfeeding.
Zulresso will likely cost an average of $7,450 per vial, for a total cost of $34,000 without insurance.
Is Zulresso Better Than Existing Antidepressants?
Dr. Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina who led the clinical trials for the drug, says three elements separate Zulresso from current treatment models: its rapid onset of action, an entirely new method of action, and the fact that the drug was specifically developed for postpartum depression.
"Within 60 hours, the majority of women that participated in these trials had a marked reduction and/or complete remission of symptoms—and that's unlike anything we have available," says Dr. Meltzer-Brody. "The best-case scenario with SSRI therapy (drugs that were not developed to treat postpartum specifically) is that it can be weeks to months, if in fact you respond.”
For women with postpartum depression, it’s inconceivable to imagine weeks or months with no treatment. That’s because PPD can be incapacitating, and it can even lead to hospitalization for some women. PPD can also reduce a mother's ability to care for her baby and prohibit mother-child bonding. A lack of bonding negatively impacts the baby's development and emotional well-being.
“The postpartum period is so vulnerable for all families, and it's also when one of the primary challenges is appropriate bonding and attachment with the baby. For women who are severely depressed, that attachment can be disrupted,” Dr. Meltzer-Brody explains. “So something that works quickly during this critical window is extraordinarily important."
Concerns Around Access to Zulresso
The cost of Zulresso, as well as the requirement of administering it in a perinatal inpatient unit, greatly limits its potential. Indeed, depression remains more common in women in lower socio-economic groups, placing Zulresso beyond the reach of the most vulnerable mothers.
Maria Muzik, M.D., a faculty member in the University of Michigan Department of Psychiatry and Department of Obstetrics and Gynecology, doesn’t like this fact. He thinks providing universal access should go hand-in-hand with Zulresso’s release.
"This is a great opportunity, and the initial results from phase three trials were very encouraging for these severely depressed moms to get better quickly," says Dr. Muzik, who is also the co-director of the university's Women and Infants Mental Health Program. "All of this is very encouraging, but the challenge will be the implementation and making it feasible and accessible for all depressed moms by having a population-level approach to this problem."
Karen Kleiman, founder and director of the Postpartum Stress Center and author of Good Moms Have Scary Thoughts: A Healing Guide to the Secret Fears of New Mothers, says the new mothers she works with are giving the news of Zulresso's approval "mixed reviews."
"Many are excited about the progress being made on behalf of women with perinatal mood and anxiety disorders. They say it feels good to have postpartum depression validated and supported through research," Kleiman says. "The reservations are from moms concerned that this research and ultimate outcome only impacts a small percentage of women and worry that the majority of mothers will continue to fall through the cracks."
The Bottom Line
Postpartum depression is often underdiagnosed and undertreated, so this new drug is meaningful in many ways. “Mental health has for so long been treated as a condition in which you should just be able to 'get over it," says Dr. Meltzer-Brody. She adds that Zulresso might help eliminate the stigma surrounding PPD and encourage women to get help.
"The most exciting part about this new drug being approved is that it sets the momentum forward for more research and new interventions," notes Kleiman. "We are hopeful that this will eventually lead to interventions that are more readily accessible and more easily administered so more women can look forward to rapid relief from symptoms that impair such a critical transition in their lives."