WASHINGTON (dpa-AFX) - AbbVie (ABBV), a global biopharmaceutical company in cooperation with Neurocrine Biosciences Inc. (NBIX), announced detailed results from two replicate pivotal Phase 3 clinical trials evaluating the efficacy and safety of Elagolix in premenopausal women who suffer from endometriosis.
The data demonstrate that, compared to placebo at month three and month six, patients treated with Elagolix reported statistically significant reductions in scores for menstrual pain (dysmenorrhea, DYS) and non-menstrual pelvic pain (NMPP) associated with endometriosis as measured by the Daily Assessment of Endometriosis Pain scale.
In the two studies, both doses of Elagolix administered orally demonstrated a statistically significant (p - 0.001) improvement versus placebo in the percentage of DYS and NMPP responders. In the first study, at month three, 46 percent of patients treated with 150 mg once daily and 76 percent of patients treated with 200 mg twice daily of Elagolix were classified as DYS responders, versus 20 percent of patients in the placebo group. Fifty percent of patients treated with 150 mg once daily and 55 percent of patients treated with 200 mg twice daily of Elagolix were classified as NMPP responders, versus 36 percent of patients in the placebo group. The second pivotal Phase 3 study demonstrated similar results.
At ASRM, AbbVie will present multiple abstracts highlighting primary and secondary efficacy and safety endpoint data from the Phase 3 studies as well as research on the economic burden of endometriosis and endometriosis-related surgery in women in the United States. AbbVie plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) for endometriosis in 2017.
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