On Tuesday, March 19th, 2019, the U.S. Food and Drug Administration approved the first-ever medication specifically for postpartum depression. The drug, Zulresso (generically known as brexanolone), is the first of its kind and is the second mental health medication to receive FDA approval this month.
Zulresso works at an astonishing rate, within 48 hours of beginning treatment: a significant improvement over other antidepressants on the market, which can take as many as four weeks to begin having an effect, if they work at all.
Experts in the mental health field claim the new treatment will provide immediate relief of symptoms for mothers whose depression is keeping them from providing their new babies with the care, nurturing, and bonding that is crucial for healthy development.
Postpartum depression affects nearly 15 percent of births worldwide, according to the National Institute of Mental Health, and can begin shortly before or any time after childbirth but typically begins between one week and one month after delivery.
“Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement quoted by The New York Times. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
But Zulresso is not without its limitations.
The new medication is to be delivered by infusion over a 60-hour period, during which the receiving patient must remain in a certified medical facility under direct supervision. Several patients reported getting dizzy or faint during clinical trials, so staff must watch for these side effects.
Another important factor is that Zulresso will be expensive, averaging $34,000 per patient before any discounts, according to Sage Therapeutics, the manufacturer. That doesn’t include the cost of staying in a medical facility for two and a half days; that’s just the cost of the medicine itself.
The infusion is to be administered just once per patient, but patients may also take other available antidepressants during treatment with Zulresso.
“The major thing is, of course, the rapid effect,” Dr. Margaret Spinelli, a clinical professor of psychiatry at Columbia University, who treats and studies postpartum depression and was not involved in the research on brexanolone, told The New York Times.
“That it’s the first that’s designed for postpartum depression is important and means it will probably be a segue to design other medications for postpartum depression to be administered in an easier way,” she added.
According to Dr. Kimberly Yonkers, a professor of psychiatry, obstetrics, gynecology and reproductive sciences at Yale, who was not involved in the Zulresso research, the drug may be helpful for up to 30 percent of the 400,000 American women who develop postpartum depression symptoms each year.
Ideal candidates for treatment with Zulresso would likely be mothers experiencing severe symptoms of postpartum depression or those who have failed to improve on standard antidepressants, according to Dr. Yonkers.
“This brings up a lot of very complex public health issues,” she added, making note of the limitations of Zulresso.
“It may be worth it, if somebody has been treatment-resistant or they can’t wait the two to four weeks for an antidepressant to kick in,” Dr. Yonkers said. “Depression can be pretty miserable,” she added.
Ms. Hathaway, one of the clinical trial participants, said that after leaving the hospital she felt like herself again. “I’m not going to say I was 100 percent, but I will say there was so much less of a gap to get there.”
Ms. Hathaway didn’t stop taking other antidepressants altogether during her treatment with Zulresso but switched to a low dose of Effexor, a common antidepressant.
Dizziness and sleepiness were the most common side effects of Zulresso treatment in the trials, each affecting about one in every eight patients, including Ms. Hathaway. The most worrisome effect, the FDA reported, was fainting or temporary loss of consciousness, which was seen in five patients. All five patients recovered within an hour and resumed getting the infusion.
Experts in the mental health field believe that FDA approval of Zulresso will likely be just the beginning, paving the way for new postpartum depression treatments in the future.