Esmya ulipristal acetate: Additional Phase III data

Additional data from the double-blind, international Phase III PEARL I trial in 242 patients showed once-daily 5 and 10 mg Esmya controlled uterine bleeding, a co-primary endpoint, in 91% and 92% of patients, respectively, at week 13 vs. 19% for placebo (p<0.001 for both). Additionally, low- and high-dose Esmya reduced median total fibroid volume, a co-primary endpoint, by 21% and 12%, respectively, vs. a 3% increase for placebo (p=0.002 and p=0.006, respectively). Furthermore, rates of amenorrhea were 73% and 82% for low- and high-dose Esmya, respectively, vs. 6% for placebo. Patients received once-daily 5 or 10 mg Esmya or placebo plus concomitant iron for 3 months. Data were published in the New England Journal of Medicine. In 2010, Gedeon's Richter's PregLem S.A. subsidiary reported that Esmya met the co-primary endpoints of superiority to placebo in reducing excessive uterine bleeding and in reducing total fibroids volume (see BioCentury, June 7, 2010). ...