Feb. 6, 2023 -- A pill that could change the way postpartum depression is treated has been submitted to the U.S. Food and Drug Administration for priority review, pharmaceutical companies Sage Therapeutics and Biogen announced.
The drug, zuranolone, would be taken once-a-day for two weeks and could replace other postpartum depression treatments that take much longer to have any effect. Because the FDA is giving the application priority review, the drug might be approved this calendar year.
“Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” Laura Gault, MD, chief medical officer at Sage, said in a news release. “We believe zuranolone, if approved, could offer a new way for physicians to support patients.”
About one in eight U.S. women giving birth experience postpartum depression, or about 500,000 annually, the drug companies said. The pill also could be used to treat major depressive disorder, which is diagnosed in about 14 million people yearly.
A clinical study of 200 women with PPD found depression decreased for about 26.5% of them in three days when they took zuranolone, compared to 12.5% who got a placebo. In two weeks, those figures went up to 57% for those getting zuranolone and 38.9% who got the placebo.
In 2019 the FDA approved a Sage Therapeutics drug that was the first anti-depressant specifically designed for PPD, The Boston Globe reported. That drug, Zulresso, was given intravenously and was a commercial failure because of its high price, about $34,000 per patient, The Globe said.
But the effectiveness of Zulresso motivated pharmaceutical companies to start new research into postpartum depression, which has been often under-studied for years, The Globe reported.