Allergan and Gedeon Richter have reported positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids.
A new drug application filing for ulipristal acetate is expected for the second half of this year.
Allergan chief research and development officer David Nicholson said: "We are pleased with the favourable results of Venus II supporting the efficacy and safety profile of ulipristal acetate as shown in our Venus I trial.
"Allergan is committed to identifying, developing and bringing to market therapies that address unmet need and provide significant value to the healthcare system, including a potential new treatment for symptomatic uterine fibroids.
"We are confident that the results of our phase III trials for ulipristal acetate may potentially offer the first and only oral treatment option for women suffering from uterine fibroids in the US."
The trial included 432 US patients with 162 and 157 patients randomised to ulipristal acetate 5mg and 10mg respectively, and 113 to placebo.
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The average age of patients enrolled was 41 and 67% of them were Black / African Americans. 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 the percentage of patients with absence of uterine bleeding and time to absence of uterine bleeding on treatment during Treatment Course One (12-week duration).
More patients in the 10mg group (54.8%) and the 5mg group (42.0%) achieved absence of bleeding compared to placebo (0%).
The secondary efficacy endpoints were the percentage of patients with absence of uterine bleeding from Day 11 to end of the first treatment course, the percentage of patients with absence of uterine bleeding after the second treatment course, time to absence of uterine bleeding on treatment during treatment course two, and the change from baseline in the UFS-QOL revised Activities subscale at the end of the first treatment course.
More patients in the 10mg group (55.4%) and the 5mg group (34.6%) achieved absence of bleeding within ten days after treatment initiation in Treatment Course One compared to placebo (0%).
A greater number of patients in the 10mg group (57.3%) and the 5mg group (40.5%) achieved absence of bleeding compared to placebo (8%) in Treatment Course Two.
The improvement from baseline in the UFS-QOL revised activities subscale was significantly higher in the 10mg group (56.7%) and the 5mg group (48.3%) compared to placebo (13%).