Uterine fibroid drug yields positive results in clinical trial

Ulipristal acetate, the first oral therapy to show safety and efficacy for women with abnormal bleeding due to uterine fibroids, may be one step closer to becoming publicly available, according to a press release.

A representative for the drug’s manufacturer, explained the significance of bringing the drug onto the market.

“Currently uterine fibroids management is mainly interventional (e.g., myomectomy, hysterectomy, embolization of uterine artery). There is currently no FDA-approved oral treatment option for uterine fibroids,” Cornelia Haag Molkenteller, MD, PhD, vice president and therapeutic area head of internal medicine, women’s health and urology, Allergan, told Healio Family Medicine. “While we cannot make any comparisons, we know that leuprolide is the only intramuscular injection approved for preoperative hematologic improvement for patients with anemia due to uterine fibroids. Ulipristal acetate may potentially be the first selective progesterone receptor modulator, administered orally, in the U.S.”

Allergan stated it is moving forward with the drug after the Venus II study reinforced an earlier study’s results regarding its safety and efficacy.

"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," David Nicholson, chief research and development officer, Allergan, said in the release. “We are confident that the results of our phase 3 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 Venus II study included 162 patients randomly assigned to 5 mg of ulipristal acetate, 157 patients assigned to 10 mg and 113 assigned a placebo over two, 12-week treatment courses, followed by 12 weeks of no treatment.

Researchers reported that during the first treatment round, more patients in the 10-mg group (55.4%) and the 5-mg group (34.6%) experienced absence of bleeding within 10 days after treatment, compared with 0% in the placebo group. During the second round of treatment, significantly more patients in the 10-mg group (57.3%) and the 5-mg group (40.5%) experienced absence of bleeding compared with placebo (8%). Compared with baseline, the improvement in quality of life, evaluated by questionnaire, was significantly greater in the 10-mg group (56.7%) and the 5-mg group (48.3%) compared with placebo (13%).

The most common adverse events with both treatments were nausea, headaches and hot flashes, according to the press release. These adverse events occurred in 5% or more of patients.

Allergan stated it anticipates filing a new drug application for their drug during the second half of this year. – by Janel Miller

Further reading:

http://www.allergan.com/NEWS/News/Thomson-Reuters/Allergan-and-Gedeon-Richter-Announce-Positive-Phas

Disclosures: Haag Molkenteller and Nicholson are employed by Allergan.