A groundbreaking medication in the treatment of postpartum depression was granted approval by federal regulators on Friday.
According to a statement from the Food and Drug Administration (FDA), when Zurzuvae (zuranolone) hits the market in a few months, it will be the first-ever oral medication designed to treat postpartum depression (PPD).
A once-daily, 14-day treatment, Zurzuvae has reportedly been shown to significantly help curb the symptoms of PPD in two recent trials.
After 15 days of treatment, 57% of trial participants experienced a 50% or more improvement in their PPD symptoms. This share bumped up to 61.9% after 45 days.
The Centers for Disease Control and Prevention reports that cases of PPD nationwide have grown sevenfold between 2000 and 2015, with approximately 1 in 8 women experiencing it.
Women’s PPD symptoms can vary but often encompass feelings of hopelessness and guilt, self-worth issues, and difficulty bonding with their newborns. In the most severe instances, mothers may have thoughts of hurting themselves or hurting their children.
PPD often has multiple causes, according to the Mayo Clinic. It can be spurred by the dramatic fluctuations in hormone levels that occur after childbirth. Some women might be more likely to have to PPD if others in their family suffered these symptoms.
Moreover, obesity — a growing epidemic in the U.S. — also contributes significantly to one’s risk of experiencing PPD, according to research conducted at the University of Utah in Salt Lake City.
The duration of PPD can vary greatly, with some experiencing these debilitating symptoms for weeks or months. Yet research has shown that less than 16% of women with PPD receive treatment.
Considering that PPD and other mental health conditions are drivers of the nationwide maternal mortality rate, the makers of the new drug, Biogen and Sage Therapeutics Inc., consider the FDA’s approval of Zurzuvae to be a significant step toward tackling this public health issue.
“The approval of ZURZUVAE to treat postpartum depression is a major milestone for the hundreds of thousands of women who experience this underdiagnosed and undertreated condition,” explained Christopher A. Viehbacher, Biogen president and chief executive officer, in a statement.
Zurzuvae is a neuroactive steroid therapy that targets the root causes of PPD, distinguishing itself from other medications to treat depression. It can cause side effects such as fatigue, dizziness, diarrhea, and urinary tract infections.
Existing drug treatments for PPD have been limited to intravenous medications available only in certain healthcare facilities due to the risk of patients falling asleep or passing out during administration.
The very first to be developed was Zulresso (brexanolone) — another drug from Sage Therapeutics — and it received FDA approval in March 2019.
Tiffany R. Farchione, the director of the FDA’s division of psychiatry, noted, “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
