Esmya ulipristal acetate: Additional Phase III data

Additional data from the double-blind, international Phase III PEARL II trial in 307 patients showed that once-daily 5 and 10 mg Esmya controlled uterine bleeding, the primary endpoint, in 90% and 98% of patients, respectively, at 3 months vs. 89% for monthly Lupron leuprorelin. Median times to amenorrhea were 7 and 5 days for low- and high-dose Esmya, respectively, vs. 21 days for Lupron. Additionally, a significantly smaller proportion of patients receiving low- and high-dose Esmya reported moderate to severe hot flashes vs. Lupron (11% and 10%, respectively, vs. 40%, p<0.001 for both). Patients received once-daily 5 or 10 mg Esmya or 3.75 mg monthly Lupron injections. Data were published in the New England Journal of Medicine. In 2010, Gedeon's Richter's PregLem S.A. subsidiary reported that Esmya was non-inferior to Lupron on the primary endpoint of reducing excessive uterine bleeding (see BioCentury, May 24, 2010). ...