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According to the FDA, the medication zuranolone, marketed as “Zurzuvae” by Sage Therapeutics and Biogen, can “provide rapid improvements” for postpartum depressive symptoms in women, such as cognitive impairment, feelings of sadness or inadequacy, fatigue, or suicidal thoughts.
Zuranolone functions as a neuroactive steroid that binds to GABA receptors in the brain, resetting imbalanced neurotransmitters in individuals with certain diseases, such as depression, schizophrenia, and other mood disorders.
Two randomized, double-blind studies on Zurzuvae found that patients who received 50 milligrams of the medication “showed significantly more improvement” in their symptoms after 15 days compared to a placebo group. In these studies, neither the participant nor the researchers knew who was receiving a placebo.
The medication is significant because it can offer a “rapid reduction of depressive symptoms” as early as three days, according to Kristina Deligiannidis, head of women’s mental health at Zucker Hillside Hospital in New York, who spoke with Fortune.
Both businesses stated that they are “evaluating next steps” in response to the FDA’s request for more research on the drug’s effects on people who suffer from other serious depressive disorders, which are thought to impact 8.3% of American adults.
The tablet will be made commercially accessible, according to the businesses, when the FDA designates it as a restricted drug, which is anticipated to occur within 90 days.
According to Postpartum Support International, many American women experience postpartum depression symptoms every year. Samantha Meltzer-Brody, director of the University of North Carolina at Chapel Hill’s Center for Women’s Mood Disorders, believes the medication “is going to be a game changer for treating maternal depression.”
After giving birth, some women experience postpartum depression, sometimes known as the “baby blues,” while the majority typically show fewer symptoms two weeks later. The signs and symptoms can appear immediately after giving birth, occasionally even during pregnancy, and they can linger for years. Up to 50% of women who experience postpartum depression keep their symptoms a secret.
The Policy Center for Mother Mental Health estimates that suicide accounts for 20% of all mother fatalities following delivery. Brexanolone, which is sold under the brand name Zulresso and can only be obtained through an IV infusion, was the only medication for treating postpartum depression that had received FDA clearance before zuranolone.
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Source: forbes