Allergan and Gedeon Richter have announced positive results from Venus I, one of two pivotal phase 3 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 10 mg and 56 to placebo. The study met all the coprimary and secondary endpoints, with both ulipristal treatment arms achieving statistically significant results over placebo (P < 0.0001). The coprimary efficacy endpoints were 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 5-mg group (47.2%; P < 0.0001) achieved absence of bleeding compared with placebo (1.8%).
"Uterine fibroids are the leading cause of hysterectomies in the U.S. Ulipristal acetate has the potential to offer the first and only noninvasive long-term treatment option for women suffering from uterine fibroids in the U.S.," said David Nicholson, Executive Vice President and President of Global Research and Development at Allergan.
The secondary efficacy endpoints were the percentage of patients with absence of uterine bleeding from day 11 to end of treatment and the change from baseline in the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) revised Activities subscale at the end of treatment. Significantly more patients in the 10-mg group (58.3%; P < 0.0001) and the 5-mg group (43.4%; P < 0.0001) achieved absence of bleeding from day 11 to the end of treatment compared with placebo (0%). The improvement from baseline in the UFS-QOL revised Activities subscale was significantly greater in the 10-mg group (59.0; P < 0.0001) and the 5-mg group (52.1; P < 0.0001) compared with placebo (21.2).
The UFS-QOL is a disease-specific symptom and health-related quality-of-life questionnaire. This questionnaire is an established instrument to assess disease impact on patient's well being in women with uterine fibroids.
There were no treatment-related serious adverse events. No patients discontinued ulipristal acetate treatment due to adverse events. The most common adverse events (5% or more) on ulipristal acetate treatment were hypertension (n = 6), increased blood creatine phosphokinase (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.
Source: Allergan; May 9, 2016.