Dysfunctional Uterine Bleeding

June 27, 2016

Allergan and Gedeon Richter announced positive results from Venus I, one of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with uterine fibroids. The study included 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10mg and 56 to placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001). The co-primary efficacy endpoints were the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding. Significantly more patients in the 10 mg group (58.3%; p<0.0001) and the 5mg group (47.2%; p<0.0001) achieved absence of bleeding compared to placebo (1.8%). There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (5%) on ulipristal acetate treatment were hypertension (N=6), blood creatine phosphokinase increased (N=5), hot flush (N=5), and acne (N=3). Venus I is the first clinical trial to report topline results. The second of two clinical trials, Venus II is anticipated to be completed this year with topline results expected in the first half of 2017. A new drug application for the treatment of uterine fibroids is planned to be submitted in 2017.