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Myovant Sciences and Pfizer Announce Positive One-Year Data from Phase 3 SPIRIT Extension Study of Once-Daily Relugolix Combination Therapy in Women with Endometriosis


Published: Jan 26, 2021
84.8% and 73.3% of women reported clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain at one year
82.8% average reduction from baseline
on the Numerical Rating Scale for dysmenorrhea from 7.4 (severe pain) to 1.3 (mild pain)
over one year
Bone mineral density loss was minimal at Week 24 and remained stable through one year
Data to be included in New Drug Application submission to U.S. Food and Drug Administration anticipated in first half of 2021
BASEL, Switzerland and NEW YORK, Jan. 26, 2021 (GLOBE NEWSWIRE) Myovant Sciences (NYSE: MYOV) and Pfizer Inc.. (NYSE: PFE) today announced that the Phase 3 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-m ....

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