On August 4, the US Food and Drug Administration (FDA) approved zuranolone, or Zurzuvae, for the treatment of postpartum depression
Treating depression is complex and time-consuming, as matching patients to the right medications is a matter of trial and error that can take weeks or even months. And postpartum depression, which affects up to 20% of new mothers in the first six weeks after giving birth, is no different, TIME writes.
On August 4, the US Food and Drug Administration (FDA) approved zuranolone, or Zurzuvae, for the treatment of postpartum depression. A drug developed by biotech companies Sage therapeutics i Biogen of Massachusetts, is a pill that women take once a day for 14 days and is the first oral treatment for major depression.
"It's amazing that we're starting to think about postpartum depression more and more and we're starting to create new treatments that have been under-recognized for a long time," said Dr. Samantha Latorre, assistant professor of psychiatry at the University of Maryland, who was not involved in the zuranolone studies.
The companies requested FDA approval of zuranolone for both postpartum and major depressive disorder and provided data supporting both indications. The agency, however, only announced the approval for postpartum treatment and did not provide an explanation for that decision in its announcement.
One study of the drug in several hundred people with major depressive disorder showed early and rapid improvement in symptoms, but the change was not sustained; by the end of the treatment period, there was little difference from baseline in patients' depressive symptoms as measured by standard tests.
The FDA reviewed a series of separate studies that included both people with postpartum depression and major depressive disorder, two related forms of depression. Among people with a major episode of postpartum depression, those randomly assigned to the drug showed statistically significant improvements in depression scores after two weeks compared to those who received a placebo. The effect seemed to last for at least a month after the women stopped taking the pills.
Some women have shown improvement as early as the third day of treatment, and the drug's rapid onset of action could be a game-changer in the treatment of depression. Currently, many people continue to experience symptoms months after starting existing antidepressant therapies that rely on chemicals in the brain: serotonin, noradrenaline or dopamine. Zuranolone promises to relieve those symptoms within a few days. This in turn could help people be more receptive to other interventions such as psychotherapy.
For women with postpartum depression, a rapid reduction in symptoms could change the relationship women have with their babies. "I see this as a tool for a woman to feel better and be able to regain her function so she can start feeling again, and start taking care of herself and communicating with her baby," says Dr. Christina Deligianidis, director of women's health at Zucker Hillside Hospital of Northwell Health and one of the researchers who led trials of zuranolone in women with the condition. "It may even reduce the long-term effects of postpartum depression on babies' neurodevelopment."
The rapid action of the drug may be due to how it works in the brain.
Zuranolone targets a receptor called GABA-A, which plays a key role in how the brain calms nerve activity. In women with postpartum depression, this response is not regulated as it should be, and stress responses, including those due to hormonal changes caused by pregnancy, are also not modulated, which can lead to imbalances in brain chemicals that contribute to depression. Zuranolone restores the function of these GABA-A receptors, modulating the brain's inhibitory response.
MJ / TIME
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