Women from Long Island were among the hundreds of new moms nationwide who participated in clinical trials that helped lead to federal approval of the first medication to treat the severe form of depression that emerges after childbirth.
Until this week, there was no medication that could be prescribed to women with postpartum depression, a condition that affects about 400,000 women in the United States annually. The U.S. Food and Drug Administration approved the drug brexanolone, a product of Sage Therapeutics, on Tuesday. The medication will be sold as Zulresso, an intravenous treatment that is infused in a hospital or special treatment center for 2½ days.
“This is a breakthrough for patients. Until [Tuesday] there were no antidepressants for women with postpartum depression,” Dr. Kristina Deligiannidis, an associate professor at the Feinstein Institute for Medical Research in Manhasset and director of women’s behavioral health at Zucker Hillside Hospital in Glen Oaks, said Wednesday.
As a psychiatrist who specializes in the mental health of women in the postpartum period, Deligiannidis said she has seen new moms in emotionally desperate condition, but the doctor underscored how surprised she was when observing how quickly women recovered from severe postpartum depression when administered the drug.
About 200 local women participated in clinical tests, which led to the drug’s approval, said Deligiannidis, who served as a principal investigator of the medication.
The drug banishes depression by acting on the complex circuitry in the brain affected by a plunge in hormone levels after childbirth. The one-time infusion is all that is needed to effectively treat postpartum depression, Deligiannidis said.
“This is the first medication of its kind,” she said. “There is no other medication that we as physicians can prescribe that has this mechanism of action.”
Despite its unique capacity to treat postpartum depression, the medication isn’t cheap.
A Zulresso infusion costs about $34,000, not including charges from the hospital or infusion center where the drug is administered, according to Sage Therapeutics.
Prior to the new drug, women with postpartum depression were prescribed traditional antidepressants, none of which were developed for depression that emerges as a result of childbirth. It would take several weeks for standard antidepressants to work, and some women never achieved adequate symptom relief, Deligiannidis said.
Postpartum depression is a major public health concern because some women are so debilitated they are unable to care for their infants — or themselves. The depression’s severity has driven some women to desperate measures.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child,” Dr. Tiffany Farchione, acting director of the FDA’s division of psychiatry products, said in a statement.
The most common side effects of Zulresso are sleepiness, dizziness and headaches. Some women fainted when administered the medication and lost consciousness. For those reasons, the FDA is restricting its use to facilities where patients can be monitored.
The drug works by mimicking the activity of a derivative of the female hormone progesterone, which is intimately involved in the menstrual cycle and in maintaining pregnancy. Levels of the hormone drop dramatically after childbirth.
“Women were coming to us extremely depressed,” Deligiannidis said. “There was no emotion in their faces; they weren’t interacting with their infants. They may not have showered in a few days or brushed their teeth. But we brought them here to our unit at Zucker Hillside and treated them with brexanolone, and by the time they left, there had been a complete transformation.
“Their families were saying, ‘Oh my God, what did you give her?’ Frankly, we were not accustomed to seeing such robust responses so quickly,” Deligiannidis added.