Wednesday, March 20, 2019

FDA Approves First Medication Specifically for Postpartum Depression

Yesterday the U.S. Food and Drug Administration (FDA) approved Zulresso (brexanolone) for the treatment of postpartum depression (PPD). It is the first drug approved by the FDA specifically for PPD. PPD is believed to be caused by the rapid change in hormones immediately after giving birth and is estimated to affect 400,000 women annually.

“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,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press announcement.

Zulresso will be available only through a restricted program called the Zulresso REMS Program. Patients must be enrolled in the program prior to treatment with the medication. Only health care professionals in a certified health care facility may administer Zulresso.

Zulresso is given as a continuous intravenous infusion over a total of 60 hours (2.5 days). Patients must be monitored for potential side effects including excessive sedation or sudden loss of consciousness. They also must be accompanied by a caregiver or family member to assist them with child care during the infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away. These requirements are addressed in a black-box warning about which patients must be counseled prior to treatment.

Zulresso, which modulates the GABA neurotransmitter, was evaluated by the FDA under Priority Review and designated as a Breakthrough Therapy in 2016. Efficacy was demonstrated in two phase 3 clinical studies in which participants were followed for four weeks after a 60-hour continuous infusion for changes in depressive symptoms. Greater symptom improvements compared with placebo were noted within 24 hours of the infusion and persisted through the end of the follow-up period.

Zulpresso is expected to be available in late June, and a single course of treatment will cost $34,000. Sage is also developing a similar PPD medication that can be taken daily in pill form.

For more information on PPD, see the Psychiatric News article, “APA Releases New Statement on Perinatal Disorders” and the Psychiatric Services article “Use of Text Messaging for Postpartum Depression Screening and Information Provision.”

(Image: PeopleImages/