On Tuesday, for the first time ever, the Food and Drug Administration (FDA) approved a new drug specifically for treating postpartum depression, a mental disorder that affects one in nine new mothers.
“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,” Tiffany Farchione, M.D., an acting director in the FDA’s Center for Drug Evaluation and Research, said in a press release.
The drug Brexanolone, which will be sold as Zulresso, is delivered via an IV drip for 60 hours over the course of three days in a medically supervised setting.
The active ingredient allopregnanolone mimics progesterone, the hormone that spikes during pregnancy and then drops after birth, causing postpartum depression. Zulresso rebalances those hormonal levels to improve mood.
Currently, women with postpartum depression are prescribed generic antidepressants, which can take four to eight weeks to be effective and even then often have little impact. Zulresso, on the other hand, has been proven to produce immediate effects that last up to 30 days following the treatment.
But the drug, which was given the FDA’s strongest warning level (a “Boxed Warning”), is not without side effects. “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…at certified health care facilities where the health care provider can carefully monitor the patient,” Dr. Farchione said in the agency’s release.
And it comes with a hefty price tag. The drug, manufactured by Sage Therapeutics, will cost about $34,000 per patient, excluding the cost of hospital or infusion center stays. Whether or not it’s covered by insurance will be up to individual providers.
Sage Therapeutics, which is also working on a pill version of the drug, expects to begin selling Zulresso in late June.