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 planned for the second half of 2017, said Allergan in its press release.
David Nicholson, Chief Research and Development Officer, Allergan said that the results of 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.
The study which included 432 U.S. patients of average age of 41, met all the co-primary and secondary endpoints with both ulipristal treatment arms achieving statistically significant results over placebo (p<0.0001).
Uterine fibroids, also known as myomas, are the most common benign growths that affect up to 80 percent of women in the United States by the age of 50 and are more prevalent in African-American women.
The current mainstay of management is mainly surgical. In fact, uterine fibroids are responsible for over 350,000 hospitalizations and are the leading cause of hysterectomies, accounting for approximately one-third of all hysterectomies annually in the US. The economic burden of uterine fibroids is also large, costing the economy over $34 billion each year, said the company.