Polycystic Ovary Syndrom (PCOS), also known as Stein-Leventhal Syndrome, is a heterogeneous disorder of chronic anovulation and hyperandrogenism believed to result from a hormonal imbalance created by a combination of increased androgens and/or insulin.
Often associated with obesity and insulin resistance, PCOS symptoms include menstrual dysfunction, acne, hirsutism, obesity, infertility, insulin resistance and polycystic ovaries by ultrasonography.
Patients are at increased risk for type 2 diabetes, metabolic syndrome, infertility, high cholesterol, high blood pressure and heart disease. EX404 is an age-appropriate formulation of an existing molecule for adolescent girls with PCOS.
U.S. Food and Drug Administration (FDA) has granted EffRx orphan drug designation (ODD) in 2015 for the treatment of adolescent pediatric polycystic ovary syndrome (PCOS).