FDA Approves First Drug Specifically for Treating Postpartum Depression

On Tuesday, the U.S. Food and Drug Administration (FDA) approved the first treatment specifically for postpartum depression. The drug, brexanolone (brand name Zulresso), must be administered with an intravenous (IV) line at a doctor’s office. According to the manufacturer, Sage Therapeutics, the drug should be available starting in late June.

Postpartum depression occurs in as many as one in seven women, according to the American Psychological Association. Symptoms typically start within a few days, weeks or months of having a baby, though signs can start during pregnancy. Like other forms of depression, postpartum depression can cause a loss of pleasure, irritability, mood swings, racing thoughts and sadness. It can be especially devastating because it can cause fear or thoughts of wanting to harm your baby.

Doctors have prescribed antidepressants and other mental health treatments off-label or without official FDA approval for postpartum depression in the past. Zulresso is a new option that has been shown in two clinical trials to effectively reduce depression symptoms in new mothers. Additional long-term testing is needed, but the initial research shows depression symptoms were still gone after 30 days. Zulresso also begins to work in about three days, much faster than other antidepressant treatments. According to Vox, experts believe it works by replenishing hormones thought to cause postpartum depression.

The new treatment, while a step forward for new mothers with postpartum depression, is not without risks. It may lead to serious side effects such as “excessive sedation and sudden loss of consciousness” that require constant monitoring by a medical professional. For this reason, the FDA only approved Zulresso with a Risk Evaluation and Mitigation Strategy (REMS) that requires extra precautions. Other side effects may include sleepiness, dry mouth and flushing.

It’s also an intensive form of treatment that requires you to enroll at an approved health care provider ahead of time. From there, you receive Zulresso through an IV infusion continuously over 60 hours (2.5 days). You must stay in the treatment facility for that entire time and your blood oxygen levels will be constantly monitored for safety. This means that newborn babies must be brought to the facility where their mom is getting treatment during those two days and women must be accompanied at all times because of the risk of passing out from the drug.

According to a press release, Zulresso should be available starting in late June. First it must be scheduled by the U.S. Drug Enforcement Administration (DEA), which could take up to 90 days. The DEA schedules or classifies drugs based on their potential medical benefits compared to the risk of addiction.

Vox reports the cost for the 60 hours of treatment is set at $34,000 per person without insurance. However, many are still optimistic Zulresso will make a big difference in many women’s lives.

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” 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 release. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”