Elagolix demonstrates sustained pain reduction in endometriosis.- AbbVie.

AbbVie announced detailed results from two replicate Phase III extension studies evaluating the long-term efficacy and safety of elagolix being evaluated for the management of endometriosis with associated pain. In the extension studies, elagolix demonstrated sustained reduction in average monthly menstrual pelvic pain and non-menstrual pelvic pain in women through the 12-month treatment period. The safety and tolerability of elagolix was consistent with the anticipated effects of reduced estradiol levels and no new safety concerns were identified with elagolix use for the 12-month treatment period. The reductions in dysmenorrhea and non-menstrual pelvic pain following six months of elagolix treatment were maintained over six additional months of treatment (12 months total) across both extension studies for both 150 mg once daily (QD) and 200 mg twice daily (BID) doses.

More than 50 percent of women were responders for dysmenorrhea and non-menstrual pelvic pain at both doses. The responder rate for painful intercourse (dyspareunia) after 12 months was higher with the 200 mg BID dose than with 150 mg QD dose, which reflects a dose-dependent effect similar to the effect reported in pivotal studies. The safety profile of elagolix was consistent with the partial hormone suppression associated with its mechanism of action. The proportion of women with new incidences of hot flush ranged between 4-8 percent across both studies and doses. These results were presented at the American Society for Reproductive Medicine Scientific Congress & Expo.