Ulipristal acetate: Ph III Venus II data

Top-line from the double-blind, U.S. Phase III Venus II trial in 432 premenopausal women ages 18-50 with abnormal bleeding due to uterine fibroids showed that 5 and 10 mg oral ulipristal acetate each met the co-primary endpoints of a greater proportion of patients with absence of uterine bleeding at week 12 (42% and 54.8%, respectively, vs. 0%, p<0.0001 for both) and of improving time to absence of uterine bleeding (p<0.0001 for both) vs. placebo. Both doses of ulipristal acetate also met the secondary endpoints of improving the percentage of patients with absence of uterine bleeding from day 11 to the end of the first treatment course at week 12 and at the end of the second treatment course at week 24, time to absence of uterine bleeding on treatment from weeks 13-24, and UFS-QOL revised Activities subscale score from baseline to week 12 vs. placebo (p<0.0001 for all). Additionally, a greater proportion of patients who received low- and high-dose ulipristal acetate achieved absence of bleeding within 10 days vs. placebo (34.6% and 55.4%, respectively, vs. 0%)...