AbbVie announces positive top-line results from second Phase III study investigating Elagolix in patients with endometriosis
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Results show Elagolix reduces endometriosis-associated pain compared to placebo.
AbbVie, in co-operation with Neurocrine Biosciences, has 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 6 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.
"Endometriosis affects an estimated 176 million women worldwide. Patients voice their frustration about the need for more treatment options to medically manage endometriosis and its often debilitating pain," said Michael Severino, executive vice president, research and development, and chief scientific officer, AbbVie. "In an effort to address this need, AbbVie conducted the largest clinical trials in endometriosis to date. We are pleased with the outcomes of the pivotal trials thus far. AbbVie will continue to pursue Elagolix as a potential new treatment for the disease's most common symptoms, including pain related to menstruation and chronic pelvic pain throughout the menstrual cycle."
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