For First Time, FDA Approves Drug for Treating Postpartum Depression

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As many as one in seven women experience postpartum depression, but there hasn’t been a treatment specific to the condition – until now.

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The FDA on Tuesday approved the first drug specifically developed for severe depression after childbirth.

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” said Dr. Tiffany Farchione of the U.S. Food and Drug Administration’s Division of Psychiatry, in a statement. “Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond.”

Characterized also by mood swings, racing thoughts and feelings of guilt or worthlessness, postpartum depression doesn’t go away on its own. It can appear days or even months after childbirth and last weeks or months if left untreated, according to the American Psychological Association.

The new drug, called Zulresso (known chemically as brexanolone), was developed by Sage Therapeutics and designated by the FDA as a “breakthrough therapy,” which speeds up the review process.

Prior to the Zulresso’s approval, women were treated with antidepressants, which can take weeks to work, according to Graziano Pinna, an associate professor of psychiatry and researcher at the University of Illinois College of Medicine.

“Zulresso provides mood improvement in hours, not weeks,” which is critical for patients with suicidal ideations, Pinna said. “You can see the response in the patient and be confident that you’re sending them home safely.”

Zulresso is an intravenous drug given to patients continuously over 60 hours. In a company-funded study of new mothers with moderate or severe postpartum depression, half of the women given Zulresso had depression end within 2.5 days, about double the rate of those in a comparison group given a placebo.

Zulresso’s active ingredient mimics alleopregnanolone, a derivative of the naturally occurring hormone progesterone, which is associated with positive mood and general well-being. During pregnancy, levels of both these hormones increase steadily, according to Pinna, who has been researching alleopregnanolone for more than two decades and developed the methodology to measure it.

After delivery, levels of the hormones drop abruptly and are often associated with negative mood, crying spells and even suicidal thoughts, according to Pinna. The infusion of Zulresso helps restore normal levels of the hormones and emotions, according to Sage Chief Executive Dr. Jeff Jonas.

Zulresso’s most common side effects were sleepiness, dizziness and headaches. A few women had more serious problems, such as fainting and losing consciousness. Because those risks could result in injury, the FDA is restricting Zulresso’s use to certified health care facilities where patients can be closely monitored throughout infusion.

Zulresso labeling contains a “boxed warning” informing patients they should not drive, operate heavy machinery or do other dangerous activities until feelings of sleepiness from the treatment have ended.

Sage said the drug will cost $34,000 without insurance, in addition to costs for staying in the hospital or infusion center to receive treatment. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan.

Sage plans to being selling the drug in late June. It’s also developing a second, similar treatment in pill form.

Pinna is also working to develop treatments for depression and postpartum depression. He says treatments such as Zulresso are very likely to be useful in treating other mood and psychiatric disorders, such as major depression and premenstrual dysphoric disorder, which causes severe irritability, depression or anxiety.

The Associated Press contributed.

Contact Kristen Thometz: @kristenthometz | kthometz@wttw.com | (773) 509-5452


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