Updated on August 4, 2023.
In a highly anticipated decision, the U.S. Food and Drug Administration (FDA) approved the drug Zurzuvae (zuranolone) for the treatment of postpartum depression (PPD) on August 4. It’s not the first treatment for the condition, which affects about one in eight women, or roughly 15 percent of births in the United States. But zuranolone is the first pill for PPD, and it has been shown to not only be effective, but also fast-acting, potentially easing symptoms of depression within a few days.
The drug was classified as a “priority review,” which means the FDA directed more resources and attention to its approval, taking action within six months—not the 10 months typical of a standard review. This designation is given to therapies that would significantly improve the safety and effectiveness of the prevention, diagnosis, or treatment of serious conditions.
PPD is depression that develops during pregnancy or within the first year after giving birth. Those affected may experience a range of depressive symptoms, including shame, guilt, severe mood swings, loss of interest in once enjoyable activities, fatigue, changes in sleep or eating habits, trouble concentrating, difficulty bonding with their newborn, and thoughts of self-harm or hurting their baby.
Zuranolone may work by restoring balance to cell networks to help reset brain function. It targets parts of the brain responsible mood, arousal, behavior, cognition, and other functions. The FDA’s decision offers a new option and new hope for those who develop this potentially life-threatening condition.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research in an August 4 news release. “Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
How safe and effective is the drug?
The FDA’s decision is based on two clinical trials. The most recent data was published on July 26 in The American Journal of Psychiatry. A total of 196 women between 18 and 45-years old were evenly divided into two groups and randomly assigned to receive either the drug or a placebo for 14 days. They did not know if they were receiving the treatment or the dummy pill. Of the 170 women who completed the study, 57 percent of those who took a daily 50mg zuranolone pill reported a 50 percent or higher improvement in their depressive symptoms, compared with 39 percent of those in the placebo group.
The researchers found some people saw an improvement in their symptoms within three days, and some continued to benefit from the drug after the 14-day treatment period, reporting an improvement in their depressive symptoms after 28 days and by the end of the study at day 45.
The drug made by Sage Therapeutics and Biogen was well-tolerated. The FDA reports the most commonly reported symptoms of zuranolone include drowsiness, fatigue, dizziness, diarrhea, nasopharyngitis (the common cold), and urinary tract infection. The FDA warns, however, that taking zuranolone may cause suicidal thoughts and behavior. It is also not safe to take during pregnancy as it may harm a developing fetus. Women on zuranolone should use effective contraception while taking the drug and for one week after treatment ends.
Before the approval of zuranolone, there was only one treatment specifically designed to treat PPD. Also developed by Sage, the drug called Zulresso is given intravenously to patients over a 60 hour period in a health care setting.
Since it’s taken by mouth in pill form, zuranolone makes effective and timely treatment for PPD more accessible to those who are affected by the condition.
Don’t wait to seek help
If you believe that you or someone you know is at risk for suicide, trust your instincts. Don’t be afraid to ask direct questions, such as “Are you thinking about hurting yourself or dying?” Having this candid talk won’t make someone more likely to take their own life. It could actually reduce the likelihood that they act on suicidal thoughts.
People considering suicide can reach out to the Crisis Text Line by texting ‘HOME’ to 741741. They will be connected with a person who will listen to their concerns without judgement. They can also call the National Suicide Prevention Lifeline at 1-800-273-8255 or call, text, or chat 988.
If you’re with someone who is actively considering suicide, do not leave that person alone. Call 911 right away or go to the nearest emergency room.
