Elagolix: Final Phase II data

Data from the 4-month, open-label portion of the Phase II Daisy PETAL trial in 137 patients showed that patients who received 150 mg daily elagolix for all 24 weeks of the trial maintained reductions from baseline in dysmenorrhea, non-menstrual pelvic and dyspareunia daily pain scores. Furthermore, patients who initially received placebo for 8 weeks in the double-blind portion of the trial and were switched to elagolix at week 8 had reduced daily pain scores on all 3 measures at week 24. Additionally, 86% of patients who received elagolix for 24 weeks achieved a PGIC score of "much improved" or "very much improved", with 74% of patients who initially received placebo for 8 weeks and were switched to elagolix for 16 weeks achieving the same scores. EHP-5 scores were also reduced by 36 and 30 points at week 24 in patients who received elagolix for 24 and 16 weeks, respectively. ...