New postpartum depression medication approved by the FDA
Brexanolone has been approved by the F.D.A. for use. However, the medication comes at a high cost to patients and healthcare facilities.
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March 25, 2019
The Food and Drug Administration approved a new medication used to treat postpartum depression on March 19.
However, the University of Iowa Hospitals and Clinics, along with other health-care facilities, will need to be certified in the FDA Risk Evaluation and Mitigation Strategies Program in order to offer it to their patients.
UI Professor Jess Fiedorowicz, a member of the FDA scientific advisory committee that recommended approval of the drug, said in an email that approximately 1-in-10 women will experience postpartum depression, a common mental disorder that occurs in women after giving birth.
“Postpartum depression is a serious condition that, when severe, can be life-threatening,” said Tiffany Farchione of the FDA’s Center for Drug Evaluation and Research in a press release. “Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond.”
The new medication, called Zulresso or Brezanolone, is administered to the patient through an IV. Fiedorowicz said Brexanolone works by modulating inhibitory receptors in the brain. The drug works quickly, greatly reducing symptoms in adult women within 24 to 48 hours.
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” Farchione said in the press release.
Despite showing rapid results, the medication has several drawbacks that make it difficult for patients to obtain. Zulresso currently costs $34,000 without factoring in additional medical fees and requires patients to stay in the hospital for 60 hours during the treatment, Fiedorowicz said.
“The need to be given over a 60-hour infusion in health-care settings, and the cost will likely be a barrier to for many women,” he said in the email.
Stacey Pawlak, a UI clinical assistant professor of psychiatry, said insurance companies do not yet cover the cost of the drug.
“My hope is that as this medication is used and found to be effective, insurance companies will cover it,” she said. “There will be the ability for anybody to use it.”
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Because there are some safety concerns, including a 4 to 5 percent risk of sudden loss of consciousness during treatment, Zulresso will only be available through the REMS Program, which requires the drug to be administered by a health-care provider in a certified health-care facility to ensure safety during the treatment, Fiedorowicz said.
The REMS Program requires that patients be enrolled in the REMS Program prior to administration of Zulresso.
Because it needs to be certified in the REMS Program, Zulresso is not currently available at UIHC. However, Fiedorowicz said the hospital is working to find an appropriate setting in which staff can meet the needs of a mother to offer the treatment here.
Pawlak said the hospital is exploring the option of having an in-patient psychiatric unit for mothers to receive treatment.
“I think it’s really exciting to have a new treatment option out there,” Pawlak said. “Postpartum depression is really common, and up until not that long ago, it was something that people didn’t really talk about or seek treatment for.”
