For the first time in history, a drug for women suffering postpartum depression has received federal approval.
“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. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
According to Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, who was the principal investigator for the brexanolone studies, the new drug (marketed as Zulresso) is a synthetic form of allopregnanolone, a hormone produced by progesterone in the brain that may help ease depression and anxiety by dampening neural activity.
The results of the tests presented, which involved 247 women with moderate to severe depression after giving birth, were considered persuasive enough by a joint FDA advisory committee which endorsed approval in near-unanimous votes.
Whereas current available antidepressants take two to four weeks to take effect (if they work at all), this new drug reportedly works within 48 hours. In fact, one mother who was part of the trial said that after 12 to 14 hours, “I actually woke up from a nap and those intrusive thoughts that played on repeat, they were gone.” It was a vast improvement as she revealed to the New York Times that prior the medication, she spent two weeks under round-the-clock suicide watch at home.
Additionally, Dr. Meltzer-Brody said the drug appears safe for nursing mothers and babies, “because very little of it seeps into breast milk.”
Meanwhile, common side effects include dizziness and sleepiness. The most worrisome effect, the FDA noted, was fainting or temporary loss of consciousness as seen in five patients, all of whom recovered within an hour and resumed the treatment.
NYT further notes that there are limitations to the new drug. One is that it is delivered by infusion over 60 hours, during which a new mother must remain in a certified medical center under supervision. Second is that the cost of infusion averages to $34,000 per patient before discounts, not including the costs of staying in a medical center for two and a half days. However, the manufacturer noted that they are currently working on a pill made with a similar molecule, which they promised would be much more accessible and easier for patients—although they are unsure how long it will take before that happens.
We are glad postpartum depression is being treated as a serious condition and the medical community is taking active steps to address it. We only hope the problem on accessibility will be addressed soon. What do you think of this new drug?