The P-III (SPIRIT 1 & 2) studies evaluates relugolix 40mg + estradiol 1.0mg and norethindrone acetate 0.5mg vs PBO in ~1,200 women with pain associated with endometriosis. The combination therapy is available as Myfembree in the US
The studies achieved co-primary EPs i.e., 75% of women achieved reductions in dysmenorrhea over 27% & 30% in PBO @24wks.; 59% & 66% vs 40% & 43% in non-menstrual pelvic pain. In the 2EPs, reductions in dyspareunia & opioid use; opioid free (86% & 82% vs 76% & 66%) @24wk., was well-tolerated including bone mineral density loss of <1% @24wks.
The results were published in The Lancet. Both study results & OLE study were incorporated into a Myfembree’ sNDA with an anticipated PDUFA date of Aug 2022
Ref: Pfizer | Image: Pfizer
