FDA approves Myfembree® for endometriosis pain management

8th August 2022

Impact of pain on daily activities measured by the Endometriosis Health Profile-30 (EHP-30) during Clinical Trials.

Myovant Sciences and Pfizer have announced that the US Food and Drug Administration (FDA) has approved Myfembree® (combination therapy of relugolix, estradiol, and norethindrone acetate), for the once-daily treatment to aid in management of moderate-to-severe endometriosis-associated pain.

Endometriosis occurs when endometrial-like tissue grows on the ovaries, bowel, and tissues lining the pelvis. It’s rare for endometrial-like tissue to spread beyond the pelvic region, but it’s not impossible. Pelvic pain is the most common symptom of endometriosis but other disruptive symptoms can include painful periods, cramps 1 or 2 weeks around menstruation, heavy menstrual bleeding. infertility, pain during sexual intercourse, discomfort with bowel movements and lower back pain that may occur at any time during your menstrual cycle.

The decision by the FDA is also supported by data from the two phase 3 studies (SPIRIT 1 and SPIRIT 2) investigating the combination tablet for treatment of dysmenorrhea. The studies met their secondary endpoints. SPIRIT 1 achieved 7 key secondary endpoints and SPIRIT 2 met 6. The evaluation included changes in mean dysmenorrhea, non-menstrual pelvic pain, overall pelvic pain, impact of pain on daily activities as measured by the Endometriosis Health Profile-30 (EHP-30) pain domain, the proportion of women not using opioids, the proportion of women not using analgesics, and change in mean dyspareunia (painful intercourse).

The Endometriosis Health Profile is a Health Related Quality of Life (HRQoL) patient self-report PRO, used to measure the wide range of effects that endometriosis can have on women’s lives.

More information on the announcement can be found here.

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