AbbVie plans NDA for endometriosis therapy

AbbVie Inc. (NYSE:ABBV) said elagolix ( ABT-620) met the co-primary endpoints in the Phase III M12-671 trial to treat moderate-to-severe endometriosis-associated pain. The trial was the second of two identically designed Phase III studies. The company plans to submit an NDA for elagolix next year.

AbbVie said 150 mg once-daily and 200 mg twice-daily elagolix reduced scores of non-menstrual pelvic pain and dysmenorrhea associated with endometriosis after three and six months of treatment as measured by the Daily Assessment of Endometriosis Pain scale vs. placebo. AbbVie plans to present detailed data this year from M12-671, which enrolled 815 premenopausal women. ...