U.S. Food and Drug Administration (FDA) has approved the first medication made to treat the symptoms of postpartum depression, which affects 1 in 9 new mothers after giving birth to their child.
The intravenous infusion of the drug brexanolone, which will be sold as Zulresso, becomes effective within hours of being consumed and has minor side effects such as headache, dizziness or excessive sleepiness, but also sudden loss of consciousness.
According to Sage Therapeutics, the company manufacturing Zulresso, the medicine will be available starting June at a price ranging between $20,000 to $35,000 per treatment. The treatment would require 60 hours of time.
"Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, Dr. Tiffany Farchione, explained.
"Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient," she elaborated.
"There are no FDA approved antidepressants for postpartum depression, so approval of the first medication of its kind is a breakthrough for patients," said Dr. Kristina Deligiannidis, the director of Women's Behavioral Health at Northwell Health's Zucker Hillside Hospital in New York, who was involved in two of the drug's clinical trials as a researcher.