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What we know about the FDA’s new postpartum depression drug

Postpartum depression is a common complication after birth, affecting hundreds of thousands of American women every year. A new treatment could offer much-needed help to some new mothers with this disorder, but questions remain about how affordable or accessible it will be.

The nation’s first medication designed to treat postpartum depression was approved by the Food and Drug Administration on Tuesday.

The new drug is “an important new treatment option,” said Tiffany Farchione, who directs the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a released statement. Here’s what we know.

How does this medication treat postpartum depression?

At this point, the drug is only approved in an injectable form — specifically, through an intravenous infusion of brexanolone (commercially called Zulresso). The cost of the medication alone is roughly $30,000. Treatment lasts for 60 hours, and according to a statement from the FDA, it must be delivered in a certified facility through the restricted Zulresso Risk Evaluation and Mitigation Strategy Program.

Medical staff must monitor a patient continuously in case she loses consciousness. Afterward, she cannot drive herself home or operate heavy machinery.

The FDA awarded the drug priority review, meaning its application from Boston-based pharmaceutical company Sage Therapeutics would receive a response within six months, instead of the 10-month standard review time. The agency also designated brexanolone as a breakthrough therapy, a distinction given to “drugs for serious or life-threatening diseases for which there is unmet medical need and for which there is preliminary clinical evidence demonstrating that the drug may result in substantial improvement.”

In clinical trials, researchers observed how patients rated symptoms of depression before and after treatment. Adverse reactions included sleepiness, dry mouth, fainting and flushing.

The drug is not meant for everyone, said Samantha Meltzer-Brody, a perinatal psychiatrist and the principal investigator behind the drug’s clinical trials. (She serves as executive medical director for the University of North Carolina Well-Being Program and receives no financial kickbacks tied to this drug’s sales.) But for people who are not responding to more conventional psychosocial therapies or medications, the downsides are small inconveniences compared to living with potentially life-threatening effects of postpartum depression, she said.

Meltzer-Brody first saw the effects of this medication five years ago at a North Carolina clinic, she said. A patient entered treatment, was depressed and withdrawn, no longer responded to her baby and had lost weight. After 24 hours of treatment, Meltzer-Brody said, the patient emerged from her room, hungry and smiling in what the psychiatrist described as a “dramatic change.”

Who is affected by postpartum depression?

Women who endure postpartum depression may feel crushed under the weight of motherhood. The National Institute of Mental Health classifies this condition as a mood disorder influenced by hormonal changes after childbirth and sleep deprivation. Symptoms range from feeling sad, overwhelmed, anxious, or withdrawn, to doubting one’s ability to care for her baby and contemplating self-harm. In severe cases, a woman may kill herself or her child.

In 2015, 13 percent of U.S. women self-reported symptoms of postpartum depression, according to the Pregnancy Risk Assessment Monitoring System, a national database that tracked maternal and child health indicators. The Centers for Disease Control and Prevention no longer updates this system. Some estimates suggest as many as 20 percent of U.S. women endure postpartum depression, said Camille Hoffman, an assistant professor of maternal fetal medicine at the University of Colorado School of Medicine who was unaffiliated with this clinical trial.

“It’s the most common pregnancy complication, and many people do not realize this,” Hoffman said in an emailed statement to the PBS NewsHour.

Risk factors may contribute to developing this disorder, such as lack of a support network around the mother and child, medical complications that emerged during the baby’s labor and delivery, and depression symptoms tied to a previous pregnancy.

A doctor should diagnose a woman with postpartum depression, the institute says, and the American College of Obstetricians and Gynecologists recommends screening for all women at least once shortly after they give birth. But screening for this disorder can be spotty, and providers and patients may yield to stigma about mental health, meaning women who may present symptoms of postpartum depression go undetected.

It’s 2019. Why is this the first medication designed to treat postpartum depression?

Psychiatry has been “stuck for 30 years” on how to develop adequate treatment for postpartum depression, Meltzer-Brody said. Using traditional means, patients must wait a month or more for a medication or therapy to take effect, and those methods may not work for everyone. Those circumstances are “horribly unfair,” Meltzer-Brody said. But “up until now, we haven’t had any other treatment options.”

“When mom is sick and not able to function well, it becomes a family crisis,” she added.

While the American College of Obstetrics and Gynecology “has no specific guidance on this new drug, it is encouraging that postpartum women may now have more options to manage a debilitating condition that affects them and their families,” said Christopher Zahn, the organization’s vice president of practice activities, in a statement to the PBS NewsHour.

And while the drug remains prohibitively expensive, a pill format is being developed and would likely be more affordable. When it would be available remains unclear, and it’s too soon to know how health insurance companies would cover the cost of this treatment, either injected or taken orally.

Issues of access and affordability are real concerns, said Kimberly Yonkers, professor of psychiatry at the Yale School of Public Health who also directs the Center for Wellbeing of Women and Mothers. This drug could offer “great news for women who want to get back to being the joys of a mother.”

“We know antidepressants work,” she said. “But this may help for people for whom other medications haven’t worked.”

Senior Producer Murrey Jacobson contributed to this report.

If you are having thoughts of suicide, go to SpeakingOfSuicide.com/resources or call the National Suicide Prevention Lifeline at 1-800-273-8255 (TALK).

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