The FDA approved Wednesday the drug Zulresso as the first treatment specifically for postpartum depression.
“Postpartum depression is a serious condition that, when severe, can be life-threatening,” said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “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.”
But, in its current form, Zulresso cannot be popped daily or every few hours.
As described in the FDA’s announcement, Zulresso is given intravenously over 60 hours in a certified healthcare facility. Patients’ blood oxygen levels will be checked constantly and they’ll be watched for “excessive sedation and sudden loss of consciousness.”
“While receiving the infusion, patients must be accompanied during interactions with their child(ren).”
One of Zulresso’s clinical trials involved a group of women with severe postpartum depression, the FDA said, and the other trial involved those with moderate postpartum depression. Each used a rating scale to measure the change in symptoms of depression.
“In both placebo-controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion,” the FDA said. “The improvement in depression was also observed at the end of the 30-day follow-up period.”
Negative side effects emerging most often during the trials were drowsiness, dry-mouth, loss of consciousness and flushed skin.
The FDA granted the approval to the drug’s manufacturer, Sage Therapeutics, a Massachusetts-based company with four women among its top 10 executives.