The announcement comes after 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.
“We are pleased with the favorable results of Venus II supporting the efficacy and safety profile of ulipristal acetate as shown in our Venus I trial,” said David Nicholson, chief research and development officer at Allergan. “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 U.S.,” he added.
“It is indeed very encouraging that we have another successful phase III study conducted in patients with uterine fibroid symptoms, which shows that ulipristal acetate could bring promising treatment for women suffering from this condition,” added Dr. István Greiner, research director at Gedeon Richter Plc. “We remain committed to the development of female healthcare products aiming towards the improvement of the quality of life of women in all age groups.”
The study included 432 U.S. patients randomized with 162 patients receiving ulipristal acetate at a 5 mg dose, 157 at 10 mg, and 113 patients on a placebo. The study met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over the placebo, according to the press statement.
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