Both Phase 3 trials were 24-week, randomized, double-blind, placebo-controlled studies evaluating the safety and efficacy of Elagolix in nearly 1,700 women with moderate-to-severe endometriosis-associated pain. The study’s co-primary endpoints were the reductions in scores of menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis, at Month 3 and Month 6, as measured by the Daily Assessment of Endometriosis Pain scale.
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Results from the second Phase 3 trial showed that continuous treatment with Elagolix 150mg once daily and 200mg twice daily for 6 months reduced both scores of menstrual pain and non-menstrual pelvic pain associated with endometriosis at Month 3 and Month 6. For the dysmenorrhea endpoint, Elagolix 150mg once daily is associated with 43.4% responders at Month 3 and 46.2% at Month 6 vs. 22.7% and 25.4% for placebo, respectively (P<0.001). For the NMPP endpoint, the 150mg dose is associated with 49.8% responders at Month 3 and 51.6% at Month 6 vs. 36.5% and 40.6% respectively for placebo (P=0.010). The 200mg twice daily dose had 72.4% (Month 3) and 76.9% (Month 6) dysmenorrhea responders and 57.8% (Month 3) and 62.2% (Month 6) NMPP responders compared to placebo (P<0.001 for all). Responder rates from the second trial are consistent with the results from the first Phase 3 study.
AbbVie plans to present detailed results from both trials at a future medical conference in 2016. The Company anticipates to submit a New Drug Application for the endometriosis indication in 2017.
Elagolix is an orally administered gonadotropin-releasing hormone (GnRH) antagonist.
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