August 7, 2023 – The FDA has approved the primary oral drug for postpartum depression, a condition that affects an estimated one in seven moms within the United States.
The pill zuranolone (brand name Zurzuvae) is a steroid that, in response to pharmaceutical company Biogen, acts on certain receptors within the brain that regulate mood, arousal, behavior and cognition. The beneficial dosage for Zurzuvae, in response to the FDA, is 50 milligrams taken once each day for 14 days, within the evening with a high-fat meal.
Postpartum depression often goes undiagnosed and untreated. Many moms are reluctant to reveal their symptoms to their family and doctors for fear of judgment on their parenting. A 2017 study found that suicide accounts for about 5% of pre- and post-natal deaths amongst women in Canada, with most of those deaths occurring in the primary three months of the 12 months following childbirth.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt and worthlessness – in severe cases, even thoughts of harming themselves or their child,” said Tiffany R. Farchione, MD, director of the Division of Psychiatry on the FDA's Center for Drug Evaluation and Research, in a press release on the approval.
It also can affect the bond between mother and child and “have consequences for the child's physical and emotional development,” she said, as women must deal with “extreme and sometimes life-threatening emotions.”
The other approved treatment for postpartum depression is an intravenous drug. However, the product requires long infusions within the hospital and costs $34,000.
The FDA approval of Zurzuvae was based partially on data from a 2023 study in American Journal of Psychiatrywhich showed that the drug resulted in significant improvements in depressive symptoms after 15 days compared with a placebo group. Improvements were seen on day three, the earliest assessment, and were maintained in any respect visits through the treatment and follow-up phases (as much as day 42).
In anxiety patients who received the energetic drug, symptoms improved in comparison with patients who received a placebo.
The most typical uncomfortable side effects reported within the study were drowsiness, dizziness and headache. Weight gain, sexual dysfunction, withdrawal symptoms and increased suicidal behavior weren’t observed.
Zurzuvae packaging will include a warning that the drug may impair the user's ability to drive and perform other potentially dangerous activities, possibly without the user's knowledge, the FDA said. For this reason, Zurzuvae users mustn’t drive or operate heavy machinery for a minimum of 12 hours after taking the pill.