The study involved the participation of 157 patients, with 101 patients randomized to ulipristal acetate 5 and 10mg and 56 to placebo, the press release noted. The clinical trial met all co-primary and secondary endpoints with both ulipristal treatment arms and statistically significant results were achieved over placebo, according to the press release.
“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 U.S. 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 U.S.,” said David Nicholson EVP and President of Global R&D, Allergan, the press release noted.
“We are delighted with this significant step forward for ulipristal acetate as it confirms and underlines that it could provide medical therapy to many women suffering from this condition,” said Dr. István Greiner, Research Director of Gedeon Richter.
Results from the follow-up clinical trial are due in the first half of 2017. A new drug application for the treatment of uterine fibroids is expected to be submitted in 2017, the press release added.
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