Allergan plc and Gedeon Richter plc announced this week the positive results of the Venus I trial.
The Phase III trial evaluated ulipristal acetate
in treating uterine fibroids. Venus I was one of two Phase III trials
evaluating the ulipristal acetate treatment. Venus II is expected to be
completed later this year.
"We are pleased with the positive efficacy and safety results demonstrated in this clinical trial," Allergan EVP and President of Global Research and Development David Nicholson said. "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."
The study evaluated 5 and 10 mg of ulipristal acetate versus a placebo. The 157 patients were divided, with 101 receiving the medication and 56 receiving the placebo. The medication was evaluated in its ability to stop abnormal uterine bleeding caused by fibroids. The results showed that 58.3 percent of the 10 mg group and 47.2 percent of the 5 mg group stopped bleeding, versus 1.8 percent of the group taking the placebo.
"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," Gedeon Richter plc Research Director Dr. István Greiner said. "We remain committed to the development of women health care products that improve quality of life for the female population in all age groups."