Phase III study of Esmya shows reduced bleeding of uterine fibroids.- Allergan.

Allergan presented new analyses of VENUS II, the second of two pivotal Phase III clinical trials evaluating the efficacy and safety of Esmya (ulipristal acetate), an investigational drug for the treatment of abnormal uterine bleeding in women with uterine fibroids. In VENUS II, more women achieved absence of bleeding (amenorrhea, the study's co-primary endpoint) with once-daily 10 mg and 5 mg UPA, relative to placebo, regardless of whether patients were Black or had a high BMI. Overall, 66.9% of patients were Black and 56.7% had BMI =30 kg/m2. In Black and Non-black patients, more achieved amenorrhea with UPA 10 mg (48.6% and 68.0%) and UPA 5 mg (34.8% and 59.6%) versus placebo (0% for both), respectively. Similar results were observed regardless of BMI, with higher amenorrhea rates following UPA 10 mg and 5 mg versus placebo respectively.

For the Second U.S. Phase III Study of UPA for Treatment of Symptomatic Uterine Fibroids, in Treatment Course 1, 157, 162, and 113 patients were randomized to UPA 10 mg, UPA 5 mg, and placebo, respectively. Significantly more patients achieved amenorrhea with UPA (10 mg, 54.8%; 5 mg, 42.0%) versus placebo. In Treatment Course 2, more patients maintained absence of bleeding with UPA 10 mg (Arm 5), 57.3%; and UPA 5 mg (Arm 3), 40.5% versus placebo (Arms 4 and 6), 8.0%. The most common adverse events (AEs), =5% in any UPA group, during Course 1 and first off-treatment were hot flush (UPA total vs placebo, 9.5% vs 1.7%), headache (7.3% vs 5.2%), fatigue (4.4% vs 4.3%), and nausea (5.4% vs 4.3%), and for Course 2 and second off-treatment was headache (4.0% vs 2.7%).

The analysis showed patient-reported improvements in social and physical activities based on the Uterine Fibroids Symptom and Health-Related Qualify of Life questionnaire (UFS-QoL). The UFS-QoL is a disease-specific, health-related quality of life instrument that measures the symptoms and impact of uterine fibroids. In Treatment Course 1, mean change from baseline in HRQoL (Health-Related Quality of Life) Total Score was greater with UPA (10 mg, 51.0; 5 mg, 42.9) vs placebo (11.2). Improvements were also observed for Revised Activities subscale score (UPA 10 mg, 56.7; 5 mg, 48.3; placebo, 13.0) and remaining UFS-QoL subscales. In Treatment Course 2, there were improvements for UPA vs placebo in HRQoLTotal Score, Revised Activities subscale score (10 mg, 54.9; 5 mg, 50.7; placebo, 20.9), and remaining subscales.