The Food and Drug Administration has recently given approval for the first-ever pill developed to treat postpartum depression (PPD), a condition affecting approximately one in seven new mothers. This groundbreaking antidepressant, known as Zuranolone, is a once-a-day medication designed to be taken over a two-week period. It will be commercially available under the name Zurzuvae. Clinical trials have demonstrated that Zuranolone effectively alleviates severe depression in new mothers. The only other medication currently on the market for PPD, Zulresso, necessitates continuous intravenous administration for 60 hours and carries a hefty price tag of $34,000.
PPD can present debilitating symptoms, including intense despair, frequent crying, thoughts of harming the baby, a sense of disconnection from the child, and feeling as though the baby belongs to someone else. In an official statement, the FDA proclaimed Zuranolone as “the first oral medication indicated to treat postpartum depression in adults.” The FDA also remarked that previous treatments for PPD were exclusively available as intravenous injections administered by healthcare providers in certain healthcare facilities.
Zuranolone, specifically developed for PPD, has demonstrated faster efficacy compared to other antidepressants currently available and is intended for short-term use over the span of two weeks. Moreover, trials have indicated that Zuranolone has milder side effects compared to other widely used antidepressants, which may cause sudden loss of consciousness, weight gain, or sexual dysfunction. Biogen and Sage Therapeutics, pharmaceutical companies, collaborated on the development of this pioneering medication. The pricing details of Zuranolone have yet to be disclosed.
Tiffany Farchione, the head of psychiatry in the FDA’s Center for Drug Evaluation and Research, emphasized that PPD is a serious and potentially life-threatening condition, manifesting as feelings of sadness, guilt, worthlessness, and, in severe cases, self-harm or harm towards the child. She affirmed that having access to an oral medication will be a beneficial option for numerous women grappling with these extreme, and sometimes life-threatening, emotions. Dr. Asima Ahmad, the chief medical officer at Carrot Fertility, a healthcare company based in Menlo Park, California, revealed that approximately 75 percent of mothers reporting PPD symptoms do not receive treatment. She further highlighted that these numbers are even higher among minority populations, with 81 percent of Black women and 76 percent of Hispanic women expressing a desire to learn more about postpartum mental health before becoming mothers, in comparison to 70 percent of women overall. Ahmad stressed the importance of addressing postpartum depression, particularly in light of rising maternal mortality rates and significant racial disparities in maternal outcomes.
Dr. Kristina Deligiannidis, the lead researcher on Zuranolone, mentioned in an interview with CBS Saturday Morning that women experienced rapid improvement in their depression symptoms as early as day three of taking the medication. Ahmad suggested that this new drug may help reduce the stigma surrounding the use of antidepressants, as its lower incidence of side effects and shorter duration of use may make it more acceptable for those seeking treatment. Zuranolone belongs to a class of drugs that target GABA receptors in the brain using a substance called a neurosteroid. Its design aims to swiftly rebalance dysregulated brain networks responsible for mood, arousal, behavior, and cognition, effectively resetting brain function. When a person is depressed, the neurotransmitters GABA and glutamate become imbalanced, affecting neuron activity. While depression treatments traditionally focus on boosting serotonin levels, emerging research suggests that targeting the GABA pathway could be equally effective.
The drug companies behind Zuranolone sought FDA approval based on the results of five trials involving major depressive disorder and two trials specifically addressing PPD. Notably, in the Phase 3 SKYLARK randomized study, women who received a 50mg dose of Zuranolone reported significant improvement in depression symptoms after just three days. The study measured PPD using the 17-item Hamilton Rating Scale for Depression (HAMD-17), with a score of zero to seven considered normal and a score of 20 or higher indicative of at least moderate severity, making women eligible to participate in the clinical trial. Women eligible for enrollment were those within six months postpartum who experienced a major depressive episode during the third trimester of pregnancy or within four weeks after childbirth. Compared to those receiving a placebo, women treated with Zuranolone experienced a greater reduction in HAMD scores after 15 days (15.6 vs. 11.6) and 45 days (17.9 vs. 14.4).
Dr. Kristina Deligiannidis further noted that Zuranolone may cause drowsiness, sedation, and headaches. One woman shared that the medication helped her from the very first day, making her feel more like herself. She expressed her belief that Zuranolone would save countless women and families. Recent attention has been drawn to PPD following a tragic incident in which a Boston mother, Lindsay Clancy, allegedly killed her three children in January after battling an extreme form of postpartum depression. In severe cases, new mothers may experience postpartum psychosis, the condition believed to have influenced Lindsay Clancy’s actions. Postpartum psychosis, which usually develops within the first week after delivery, causes a distorted perception of reality, making normal functioning difficult. However, mental health professionals possess an array of antidepressant medications that can effectively alleviate symptoms. The medication does not need to be specifically tailored to PPD to be effective. In addition to medication, talk therapy serves as a valuable tool for millions of women struggling with post-pregnancy challenges.
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