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Zuranolone has received FDA approval for addressing postpartum depression in adults.
In an innovative move, the U.S. Food and Drug Administration (FDA) has provided its approval to Zuranolone, marking the first-ever oral treatment aimed at addressing adult postpartum depression (PPD). This development expands management options for PPD, a form of major depressive episode occurring post-childbirth, or even in late pregnancy stages. Previously, PPD management solely relied on intravenous injections given within particular healthcare facilities. PPD represents a grave and potentially perilous state wherein women grapple with emotions like sadness, guilt, and feelings of worthlessness.
In severe instances, these feelings can extend to thoughts of self-harm or harm towards their child. Notably, this condition's impact isn't confined solely to the individual; it can also adversely affect the maternal-infant bond and subsequently influence the child's emotional and physical growth.
Similar to various forms of depression, PPD manifests with symptoms like feelings of sadness and a reduced interest in once-enjoyed activities, accompanied by a diminished capacity to experience pleasure. Its symptoms encompass cognitive difficulties, emotions of sadness or inadequacy, lowered energy levels, and even thoughts of suicide.
Zuranolone's effectiveness in addressing adult PPD was established through comprehensive research involving two multicenter studies. Conducted in a randomized, placebo-controlled, double-blind manner, the trials enrolled PPD-affected females who fulfilled the criteria for a major depressive episode in accordance with the Diagnostic and Statistical Manual of Mental Disorders. These individuals began experiencing symptoms either in their 3rd trimester or within 4 weeks of parturition. During Study 1, participants were administered 50 mg of Zuranolone or placebo daily for 14 days, while Study 2 involved another Zuranolone product, approximately equivalent to 40 mg of Zuranolone. Monitoring extended for a minimum of four weeks post-treatment.
The studies' key goal was to gauge changes in symptoms of depression utilizing 17-item Hamilton depression rating scale (HAMD-17) total score on 15th day. Impressively, the Zuranolone groups showcased substantial symptom improvement compared to placebo groups, a positive effect sustained up to Day 42 after the last Zuranolone dose. It's worth highlighting that Zuranolone is accompanied by a boxed warning about potential impairments in activities like driving. Individuals are cautioned against operating machinery or driving for at least twelve hours following medication use. Common side effects encompass urinary tract infections, common cold, fatigue, diarrhea, dizziness, and drowsiness.
Notably, Zuranolone carries a risk of inducing suicidal thoughts and behavior, alongside fetal harm, necessitating the usage of effective contraception. Administered at 50 mg once daily for 14 days, Zuranolone should be consumed with a fatty meal in the evening. Hence, the availability of an oral medication offers a valuable alternative for numerous women contending with intense, and occasionally, life-threatening emotions. This pioneering oral medication offers new hope for women grappling with the challenges of PPD.
US-FDA
FDA Approves First Oral Treatment for Postpartum Depression
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