The Food and Drug Administration (FDA) has officially approved the first oral tablet to help treat postpartum depression.
Zurzuvae (zuranolone) is the newly approved medication, which is recommended in a once-daily 50 mg dose for 14 days.
Prior to this drug, the only other treatment option for postpartum depression was an injection of the drug brexanolone. However, only certain medical facilities administered it, and it required 60 hours of IV injection to be clinically effective for women.
Zurzuvae, which is manufactured by Sage Therapeutics, allows new mothers to treat their mental health from home with a daily tablet.
“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,” said Dr. Tiffany R. Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.
“And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development. Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings.”
What are the risks?
The FDA reported that zurzuvae comes with some side effects, including dizziness, fatigue, urinary tract infection, drowsiness, the common cold, and diarrhea. Some patients in the clinical trial have also reported suicidal thoughts.
The agency also recommends that women stay away from driving or performing other dangerous activities, as it may take some time to notice how the drug affects your body.
It’s also important to note that women should be using contraception while taking Zurzuvae, as well as for one week after, as the drug can cause harm to a fetus in the womb.
How well does it work?
Prior to FDA approval, Sage Therapeutics conducted two clinical trials to test the effectiveness of Zurzuvae. To be eligible to participate in the study, women had to experience postpartum depression symptoms within four weeks of giving birth or in their third trimester of pregnancy; they also had to meet the clinical guidelines for a major depressive episode.
In one study, patients were given either 40 mg of Zurzuvae or a placebo for 14 days, and were monitored throughout the two weeks, and then for four weeks after taking the drug.
In the other study, the women received either 50 mg of Zurzuvae or a placebo for 14 days, and they were also monitored for four weeks. Throughout the course of both trials, researchers assessed the participants’ symptoms using the Hamilton depression rating scale.
Researchers said it was clear at the end of both trials that Zurzuvae proved to be effective at improving women’s postpartum depression symptoms. In the most recent study, which tested 50 mg of Zurzuvae, nearly 60% of the women said that their depression symptoms had improved by 50% or more after the two weeks. Comparatively, 38% of those receiving the placebo reported the same findings.
By the end of the monitoring period, nearly 62% of those taking Zurzuvae were still seeing high improvements, compared with 54% taking the placebo.
The FDA has given Zurzuvae a Fast Track designation, and the final drug approval is expected in around 90 days.