The Food and Drug Administration (FDA) has approved the first oral treatment for postpartum depression. The drug, called zuranolone and branded as Zurzuvae, is a once-a-day pill developed by drugmakers Sage Therapeutics and Biogen. It is approved for use in adults experiencing postpartum depression, a form of major depression that can occur after childbirth or in the later stages of pregnancy and affects approximately 15% of women.
According to Dr. Tiffany Farchione, director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, having access to an oral medication will be a beneficial option for many women dealing with extreme and sometimes life-threatening feelings associated with postpartum depression.
The pill is designed to be taken for just two weeks, and patients often start to experience improvement quickly. Dr. Kristina Deligiannidis, who led the study of the drug, stated that women reported rapid improvement in their depression as early as Day 3. Postpartum depression can be severe and may last for months or even years.
Prior to zuranolone, the only approved treatment for postpartum depression was brexanolone, also developed by Sage Therapeutics. Brexanolone must be administered as an IV infusion and was approved by the FDA in 2019 as the first treatment specifically for postpartum depression.
Similar to brexanolone, zuranolone is believed to work as a fast-acting steroid that binds to GABA receptors in the brain. This helps reset neurotransmitters that are disrupted in patients with depression. However, zuranolone is taken orally, providing a more convenient option compared to the IV infusion required for brexanolone.
Zuranolone’s label will carry a warning that patients should not drive or operate machinery for 12 hours after taking the drug. Common side effects include drowsiness, dizziness, diarrhea, fatigue, the common cold, and urinary tract infections. There is also a risk of suicidal thoughts, and the drug may cause fetal harm, so women taking it are advised to use contraception.
Sahar McMahon, a participant in the clinical trial, experienced depression and anxiety after giving birth to her second child. She reported feeling more like herself after taking zuranolone and believes it will save many women and families.
Before zuranolone can enter the market, it needs to clear a 90-day Drug Enforcement Administration scheduling process. The cost of the drug has not yet been announced by the companies.
While Sage Therapeutics and Biogen originally sought FDA approval for zuranolone to treat both postpartum depression and major depressive disorder (MDD), the FDA only approved it for postpartum depression in their recent decision. The lack of approval for MDD restricts the companies from marketing the drug for that use. The FDA notified the drugmakers that they did not provide substantial evidence of effectiveness to support zuranolone’s approval for treating MDD and further research will be needed.
Despite the setback for MDD, a recent clinical trial found that a 14-day course of zuranolone helped prevent further depressive episodes in many patients for months. This differs from common antidepressants that can take longer to yield effects and may be taken for a lifetime. However, the drugmakers faced earlier setbacks in 2019 when a Phase 3 study fell short of its goal to outperform a placebo in treating depression.
The approval of zuranolone as an oral treatment for postpartum depression marks a milestone in providing a more accessible and effective option for women struggling with this condition. With further research, it may also have the potential to impact the treatment of major depressive disorder in the future.