Phase III trial of elagolix in endometriosis meets primary endpoint- AbbVie/Neurocrine Biosciences

AbbVie and Neurocrine Biosciences have announced positive top-line results from the second of two replicate pivotal Phase III clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer pain from endometriosis. Trial results show that after six months of continuous treatment, both doses of Elagolix (150 mg once daily and 200 mg twice daily) met the study's co-primary endpoints. Elagolix reduced scores of menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis, at month three and month six, as measured by the Daily Assessment of Endometriosis Pain scale.

Responder rates for the co-primary endpoints from this second Phase III pivotal study are consistent with results from the first Phase III pivotal study. The safety profile of Elagolix in this study was consistent with observations from the first Phase III pivotal study and prior Elagolix studies. Among the most common treatment-emergent adverse events (TEAEs) were hot flush, headache, and nausea. The top-line results are from a six-month, group-level analysis. Patients in the trial will continue on in either post-treatment follow-up or a blinded extension study for an additional six-month safety and efficacy evaluation.

AbbVie intends to present detailed results from its two Phase III trials at a future medical conference in 2016. AbbVie will complete the clinical database in anticipation of a New Drug Application submission for endometriosis in 2017.