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Some respite from one of the main causes of maternal mortality could be on the way, after the US Food and Drink Administration (FDA) approved the first oral medication for postpartum depression (PPD).
The drug, called Zurzuvae (zuranolone) and made by Sage Therapeutics and Biogen, is to be launched commercially in the US by late 2023 following its approval in early August.
“Maternal mental health has been sidelined for far too long, but today’s approval of Zurzuvae helps to change that. Women have been waiting for an oral medicine that can specifically and rapidly improve the symptoms of PPD and we are proud to be able to deliver that,” said Barry Greene, Sage’s chief executive.
Mental health conditions are a leading cause of maternal mortality, according to Sage and Biogen, with PPD one of the most common complications arising out of pregnancy.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness — even,” said Tiffany R. Farchione, a doctor and director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
Farchione warned the condition “can disrupt the maternal-infant bond” and “can also have consequences for the child’s physical and emotional development.”
The 50 mg dose can cause drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infection in the mother, the FDA cautioned, adding that it can also lead to fetal damage.
The FDA, however, declined to approve the drug as a treatment for the more common major depressive disorder (MDD), before Sage stock felll by over 40% on August 7 .
