Ph III trial for AbbVie's elagolix meets endpoints

US pharma major AbbVie (NYSE: ABBV) and partner Neurocrine Biosciences (Nasdaq: NBIX) have announced positive top-line results from the first of two ongoing Phase III clinical trials, designed to evaluate the efficacy and safety of elagolix in premenopausal women with endometriosis.

Results from the trial show that, after six months of treatment, both doses of elagolix (150mg once daily and 200mg twice daily) met the study's co-primary endpoints (p<0.001) of reducing scores of non-menstrual pelvic pain (NMPP) and menstrual pain (or dysmenorrhea), associated with endometriosis, at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale.

"Endometriosis is a condition in which the tissue that normally lines the inside of a woman's uterus grows outside the uterus, and is often associated with severe, and at times, debilitating pain," said Michael Severino, executive vice president, R&D, and chief scientific officer, AbbVie, adding: "The positive results from this trial represent a significant milestone in the development of elagolix as a potential new treatment option for patients suffering from endometriosis."