CHARLOTTE, NC (WBTV) - The Food and Drug Administration (FDA) announced on Tuesday that it has approved the first-ever postpartum depression drug for mothers.
Zulresso (brexanolone) will now be offered to certain patients through IV injection in the treatment of postpartum depression (PPD) in adult women.
Patients who are prescribed the treatment will be enrolled in the Zulresso REMS Program at their local healthcare facility where the drug will be administered by a healthcare professional. While receiving the infusion, patients must be accompanied during interactions with their child(ren).
Patients will receive a total of 60 hours of treatment and will be counseled throughout that time and monitored by healthcare professionals. Sleepiness, dry mouth, loss of consciousness and flushing are the primary adverse effects found from the drug at this time.
In two controlled trials examining the effectiveness of the drug, researchers found a significant improvement in symptoms among patients over a 30-day period.
“Postpartum depression is a serious condition that, when severe, can be life-threatening." said Tiffany Farchione of the FDA, "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.”