About 1 in 9 new mothers in the United States experience depression after giving birth, according to the Centers for Disease Control and Prevention (CDC). For severe cases, doctors may prescribe antidepressants, but these can take up to two months to start working, noted an article published on July 28, 2016, in UIC Today. This week the FDA approved Zulresso (brexanolone), the first drug to specifically treat postpartum depression. The new medication is administered through a continuous intravenous infusion over a 60-hour time period. While the process is more involved than taking a daily pill, the treatment can relieve depression symptoms within two-and-a-half days. “The consequences of a new mother being depressed over many months are tremendous — for the mother, for her family, and for her infant’s development,” says Kristina Deligiannidis, MD, director of women’s behavioral health at Zucker Hillside Hospital in Glen Oaks, New York. “So getting the mother well as fast as possible is critical. Many new mothers feel they can’t live like this for several months.” In fact, suicide is a leading cause of death among new mothers. One in five women with postpartum depression may have thoughts of harming themselves, according to a study published in May 2013 in the journal JAMA Psychiatry. Depression can interfere with mother-child bonding, and women may even have thoughts of hurting their baby.
Effective for Moderate to Severe Depression
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," says Tiffany Farchione, MD, acting director of the division of psychiatry products at the FDA’s Center for Drug Evaluation and Research, in a statement. Clinical trials of Zulresso have proven the drug to be very effective with mothers suffering from moderate to severe depression. About three-quarters of study participants taking the drug achieved at least a 50 percent reduction in symptoms, according to Dr. Deligiannidis, who served as a principal investigator during the brexanolone trials, published in September 2018 in the journal The Lancet. About one-half had complete remission and were no longer considered clinically depressed. They resumed their normal functioning, behaviors, and emotions. These levels of wellness began within the 60 hours of treatment and were maintained during the 30-day follow-up. Researchers need to do additional work to see if the effects can be maintained without more treatment beyond that point. Data showed that the levels of Zulresso found in the breast milk were considered safe for breastfeeding, but the FDA will make a final decision on this during the next 90 days. The most common side effects were headache, dizziness, and excessive sleepiness.
Patients Need to Be Closely Monitored
Because patients on Zulresso are at risk of suddenly losing consciousness, the FDA is requiring that the drug be administered by a healthcare provider in a certified facility. Attendants must also continuously monitor oxygen levels in the blood. “If there is excessive sedation, a healthcare professional can just turn off the pump and the side effects subside very quickly, unlike an oral medicine where you have to wait longer for the drug to go through your system,” says Deligiannidis. She notes that the mothers do not have to stay in bed during the treatment. “A peripheral IV allows you to walk around, do work on the computer, read, chat with family on the phone, have visitors — do whatever you wish within the hospital setting,” she says.
Issues of How Treatment Is Administered and Cost
Adi Davidov, MD, interim chairman of the department of ob-gyn at Staten Island University Hospital in New York, recognizes that the medication may be helpful but questions how many new mothers will want to be hooked up to an IV for so long. “If it’s an IV over 60 hours, I don’ t think it’s going to be something we give first-line for women who have postpartum depression,” says Dr. Davidov, who says he sees “full-blown” postpartum depression in about 5 percent of the new mothers he treats. Then there’s the matter of cost. Sage Therapeutics, the manufacturer of Zulresso, says that it is pricing the drug at around $34,000 per course of treatment.
Will an Oral Version Follow?
Brexanolone is the first drug in its class and works on an entirely different mechanism compared with other popular antidepressants. The drug targets brain receptors that are sensitive to fluctuations in hormone levels. “It’s really unique how it interacts with the receptor and what type of receptor it interacts with,” says Deligiannidis. An oral version of the drug could possibly lower the cost of the treatment, and scientists have one in the works. Brexanalone is an IV formulation of the substance allopregnanolone. Deligiannidis and other researchers completed trials of an oral version of allopregnanolone in January, according to an article published by Sage Therapeutics. The course of treatment involves taking a pill a day over two weeks. “The data was very similar, with benefit within three days of starting to take the oral medicine,” says Deligiannidis. There is no timetable yet for when the FDA will review the oral version. Davidov emphasizes that current available treatments can be very effective. He often finds that his patients benefit from selective serotonin reuptake inhibitors (SSRIs).
Support Is Key in Treating Postpartum Depression
Having a support network is also extremely important in the management of postpartum depression, Davidov notes. “At least once a week, a new mother needs to take time off from her child and take care of herself. So she needs to get a family member, significant other, friend, or babysitter to take care of the child,” says Davidov. ”Then she needs to go out and do something that she enjoys, because one of the problems with depression is what we call anhedonia — that’s the medical terminology meaning nothing makes you happy.” The U.S. Preventive Services Task Force recommends all new mothers get screened for depression. Deligiannidis expects that Zulresso will be commercially available in 90 days once the FDA finalizes the packaging information that comes with every medicine. “The drug is another tool in our toolbox for treating postpartum depression,” she says. “I think that postpartum depression has been marginalized for many years and the public has told women that they should grin and bear it and push through. But women should know: There are treatments available.”
