Allergan: Phase III Study Met Goals For Ulipristal Acetate In Uterine Fibroids

(RTTNews) - Allergan plc (AGN) and Gedeon Richter Plc announced Monday 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 phase III study for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids met all co-primary and secondary endpoints and achieved statistically significant results.

Venus I study was a multi-center, randomized, double-blind, placebo-controlled clinical trial in premenopausal women between 18 and 50 years old with cyclic (22 to 35 days) abnormal uterine bleeding.

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 co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo.

The co-primary 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 and the 5 mg group achieved absence of bleeding compared to placebo.

David Nicholson EVP and President of Global R&D, Allergan, said, "We are pleased with the positive efficacy and safety results demonstrated in this clinical trial. Uterine fibroids are the leading cause of hysterectomies in the US. Ulipristal acetate has the potential to offer the first and only non-invasive long-term treatment option for women suffering from uterine fibroids in the US."

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.