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Myovant Sciences and Pfizer announce positive one-year data from phase III SPIRIT extension study of once-daily relugolix combination therapy in women with endometriosis.

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Published:27th Jan 2021
Myovant Sciences and Pfizer Inc. announced that the Phase III SPIRIT long-term extension study of the investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain over one year (52 weeks) with minimal and stable bone mineral density loss. The data are consistent with the efficacy and safety profile observed through 24 weeks in the Phase III SPIRIT 1 and SPIRIT 2 studies. These results will be included in the New Drug Application to the FDA for relugolix combination tablet for the treatment of women with endometriosis, anticipated to be submitted in the first half of 2021. In the SPIRIT long-term extension study, 84.8% and 73.3% of women receiving relugolix combination therapy over one year achieved clinically meaningful pain reductions in dysmenorrhea and non-menstrual pelvic pain, respectively. On average, women reported an 82.8% reduction on the 11-point Numerical Rating Scale (0-10) for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain) over one year.
Condition: Pain; Endometriosis
Type: drug

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