2020-10-21 08:51:28 MYOV Myovant Sciences
10/21/20 10/2108:51 10/21/2008:51 | Myovant Sciences presents additional data on relugolix combination therapyMyovant Sciences announced the presentation of data from clinical studies of its once-daily relugolix combination therapy in women with endometriosis and in women with uterine fibroids. The data were presented in virtual oral and poster sessions during the American Society for Reproductive Medicine 2020 Virtual Congress, held October 17-21, 2020. The Phase 3 SPIRIT program evaluated the efficacy and safety of once-daily relugolix combination therapy in women with endometriosis. The SPIRIT 1 and 2 studies achieved their co-primary endpoints, demonstrating clinically meaningful reductions in dysmenorrheaand non-menstrual pelvic pain. Efficacy and Safety of Relugolix Combination Therapy in Women with Endometriosis-Associated Pain: Phase 3 Randomized, Double-Blind, Placebo-Controlled Study: In the SPIRIT 1 and 2 studies, relugolix combination therapy resulted in a clinically meaningful reduction in dysmenorrhea and non-menstrual pelvic pain in women with endometriosis compared with placebo. Dysmenorrhea rapidly decreased from severe at baseline to mild by Week 8 which was sustained through Week 24. Non-menstrual pelvic pain decreased from moderate at baseline to mild over 24 weeks. Both studies also met several key secondary endpoints including reduction in dyspareunia and the EHP-30 pain domain. Changes in bone mineral density over 24 weeks were minimal in the relugolix combination therapy group. The Phase 3 LIBERTY program evaluated the efficacy and safety of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding associated with uterine fibroids in two replicate studies, LIBERTY 1 and 2. The primary endpoint of both studies was met with a significant proportion of women treated with relugolix combination therapy achieving the responder criteria for reduction in menstrual blood loss compared with placebo after 24 weeks of treatment. Eligible women who completed the studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of 52 weeks. |
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