The Food and Drug Administration (FDA) has approved Orilissa (elagolix; Abbvie) for the management of moderate to severe pain associated with endometriosis. Orilissa is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist approved for this indication.
The approval was based on data from 2 multinational double-blind, placebo-controlled Phase 3 trials involving 1686 premenopausal women with moderate to severe pain associated with endometriosis. Patients were randomized to receive either Orilissa 150mg once daily, Orilissa 200mg twice daily, or placebo; the co-primary endpoints were the proportion of patients whose dysmenorrhea responded to treatment at Month 3 and the proportion of patients whose non-menstrual pelvic pain responded to treatment at Month 3. Both endpoints were evaluated using the Endometriosis Daily Impact Scale; patients who experienced a reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use for endometriosis-associated pain were considered responders.
Result showed that compared with placebo, a higher proportion of patients treated with Orilissa 150mg once daily and 200mg twice daily were responders for daily menstrual pain (Study 1: 46% and 76%, respectively vs 20% for placebo; Study 2: 43% and 72%, respectively vs 23% for placebo) and non-menstrual pelvic pain (Study 1: 50% and 55%, respectively vs 36% for placebo; Study 2: 50% and 58%, respectively vs 37% for placebo) at Month 3.
In addition, treatment with Orilissa 150mg once daily and Orilissa 200mg twice daily was associated with a statistically significant reduction from baseline in endometriosis pain based on numeric rating scale (NRS) score vs placebo at Month 3 (P<.001). Moreover, both treatment arms showed statistically significantly greater mean decreases from baseline vs placebo in dysmenorrhea and non-menstrual pelvic pain scores at Month 6.
With regard to dyspareunia, a secondary endpoint in both trials, patients treated with Orilissa 200mg twice daily showed statistically significantly greater reduction in dyspareunia from baseline to Month 3 vs those given placebo.
The most common adverse reactions in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related side effects and mood changes.
Orilissa is contraindicated in women who are pregnant, in patients with known osteoporosis, and in those with severe hepatic impairment. In addition, concomitant use of strong organic anion transporting polypeptide 1B1 inhibitors (e.g., cyclosporine, gemfibrozil) is contraindicated.
Orilissa is expected to be available in early August 2018 as 150mg and 200mg tablets.
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