Relugolix, Potential Endometriosis Therapy, Seen to Ease Pain of Uterine Fibroids in Phase 3 Study

Relugolix, Potential Endometriosis Therapy, Seen to Ease Pain of Uterine Fibroids in Phase 3 Study

Relugolix robustly lowered pain in a Phase 3  study in Japan of women with uterine fibroids, further supporting it as a potential treatment for women with these fibroids or endometriosis, a condition for which the compound also is being examined.

The study (NCT02655224) demonstrated that 57.6 percent of the women achieved substantial pain control, compared to only 3.1 percent in the placebo group, according to Myovant Sciences, which is developing the treatment together with Takeda Pharmaceutical in Japan.

Recent results from Takeda’s other study showed that the treatment reduced menstrual bleeding in 82.2 percent of women.

“Two Phase 3 studies of relugolix conducted by Takeda have now demonstrated significant benefit on the two most debilitating symptoms suffered by women with uterine fibroids,” Juan Camilo Arjona Ferreira, Myovant’s chief medical officer of sciences, said in a press release.

“Treatment with relugolix significantly decreased heavy menstrual bleeding and now pain associated with uterine fibroids, with the majority of women in the current study experiencing little or no pain by the end of the 12-week study.”

The study investigating pain included 65 women who randomly received an oral daily dose of 40 mg relugolix or a placebo for 12 weeks. Patients were assessed with a pain rating scale, where zero meant no pain and 10 the most severe pain.

All participants had a score of at least four when the study began. At its end, 57.6 percent of relugolix-treated women met the trial’s goal of a score of 1 or 0. Only about 3 percent of controls achieved this level of pain control.

Side effects were mainly linked to the estrogen-lowering properties of the treatment, such as hot flushes, abnormal sweating, or increased menstrual bleeding. Researchers said no new safety issues emerged during the trial.

While Takeda has run two studies in patients with uterine fibroids in Japan, Myovant has two ongoing Phase 3 trials, called SPIRIT 1 (NCT03204318) and SPIRIT 2 (NCT03204331), in endometriosis-related pain. The trials are still recruiting participants across the U.S. Information is available by clicking on their identification numbers.

Data from an earlier Phase 2 study (NCT01458301), in nearly 500 women, showed that the treatment lowered pain in a safe and well-tolerated manner. The SPIRIT trials are expected to run until 2020.