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www.fdanews.com/articles/175371-abbvies-endometriosis-pain-candidate-meets-primary-endpoints-in-phase-3

AbbVie’s Endometriosis Pain Candidate Meets Primary Endpoints in Phase 3

February 17, 2016

AbbVie and Neurocrine Biosciences’ Elagolix achieved its co-primary endpoints in the second of two pivotal Phase 3 trials to treat endometriosis pain in premenopausal women.

Both the 150- and 200-mg doses of Elagolix reduced scores of menstrual pain and non-menstrual pelvic pain at months three and six compared with placebo. The scores were measured by the Daily Assessment of Endometriosis Pain scale.

According to AbbVie, the results are consistent with those from the first Phase 3 study. The drugmaker is planning to submit an NDA in 2017.