February 6, 2023 – A pill that would transform the treatment of postpartum depression has been submitted to the U.S. Food and Drug Administration for priority review, pharmaceutical firms Sage Therapeutics and Biogen said.
The drug, zuranolone, is meant to be taken once every day for 2 weeks and will replace other treatments for postpartum depression that take for much longer to take effect. Because the FDA is granting the appliance priority review, the drug may very well be approved this calendar yr.
“Most currently approved therapies take weeks or months to work. We are committed to advancing treatments that can help physicians and patients by quickly addressing the symptoms of depression,” said Laura Gault, MD, Chief Medical Officer at Sage, in a Press release“We believe that if approved, zuranolone could provide a new way for physicians to support patients.”
About one in eight women within the United States suffers from postpartum depression when giving birth, or about 500,000 a yr, the drug firms said. The pill may be used to treat major depressive disorder, which is diagnosed in about 14 million women every year.
A clinical study Of 200 women with PPD, one study found that depression improved in about 26.5% of them inside three days after they took zuranolone, in comparison with 12.5% who received a placebo. Within two weeks, these numbers rose to 57% for individuals who received zuranolone and 38.9% who received the placebo.
In 2019, the FDA approved a drug from Sage Therapeutics, the primary antidepressant developed specifically for PPD. The Boston Globe This drug, Zulresso, was administered intravenously and was a industrial failure because of its high price of about $34,000 per patient. The globe said.
But the effectiveness of Zulresso motivated pharmaceutical firms to start out latest research into postpartum depression, which has often been inadequately researched for years. The globe reported.