McMahon, who had given birth four months earlier, enrolled right away in a phase three trial of the postpartum depression pill called zuranolone.
She didn’t know whether she was receiving the drug or a placebo because the research was double-blind, but she claims to have noticed an immediate improvement in her mood, energy, and motivation to interact with her children.
FDA Gives Review to Zuranolone Postpartum Depression Pill
The United States Food and Drug Administration has given Zuranolone, a daily pill administered over the course of two weeks, priority consideration while it considers the medication for approval, according to the drug’s manufacturers, Sage Therapeutics and Biogen.
Zuranolone is still in the clinical trial stage. An application for a drug that, if approved, would significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
When compared to standard applications that will receive a priority review designation, it means the FDA will focus its attention and resources on the evaluation of the application.
The American Journal of Psychiatry released the findings from the phase three trial on Wednesday.
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Zuranolone’s Oral Treatment Success
In a study of 196 women with severe postpartum depression, those who took zuranolone in pill form at a dose of 50 milligrams per day for 14 days had significantly less severe depressive symptoms than those who received a placebo.
The study, which was supported by Sage Therapeutics and Biogen, found that these improvements were still present 28 and 45 days after the initial observation.
Results are a component of a set of information that the FDA will undoubtedly review. According to Judite Blanc, assistant professor of psychiatry and behavioral sciences at the University of Miami Miller School of Medicine, the new phase three trial suggests that zuranolone might offer a quick and effective oral treatment for postpartum depression across diverse groups of women.
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