ORILISSA was rigorously studied to determine its effectiveness and safety profile1
The efficacy, safety, and tolerability of ORILISSA were demonstrated in the largest endometriosis Phase 3 study program to date (N=1686)1,2

- Two robust, similar, multicenter, double-blind, placebo-controlled Phase 3 trials (ELARIS EM-1and ELARIS EM-2) of 6-month treatment at 2 doses as compared with placebo1
- Patients who entered the studies had endometriosis pain that was beyond mild, and ~88% reported having at least 1 previous medical treatment for their pain1,3
- Women were surgically diagnosed (laparoscopy or laparotomy) with endometriosis in the last 10 years2
Endpoints
Co-primary endpoints1,2
- Proportion of responders for dysmenorrhea at month 3 compared with placebo†
- Proportion of responders for NMPP at month 3 compared with placebo†
Responder1,2
Rigorous responder
definition included both:
Clinically meaningful
pain reduction†
AND
Stable or decreased
NSAID or opioid use
Select ranked secondary endpoints1,2
- Change from baseline to month 6 in dysmenorrhea on the Endometriosis Daily Pain Impact Scale
- Change from baseline to month 6 in non-menstrual pelvic pain on the Endometriosis Daily Pain Impact Scale
- Change from baseline to month 3 in dyspareunia on the Endometriosis Daily Pain Impact Scale
- Only participants who were sexually active during the trial were included in the results for dyspareunia
†Women were defined as responders if they experienced clinically meaningful pain reduction and stable/decreased rescue analgesic use for endometriosis-associated pain. Clinically meaningful reduction in pain was defined as a calculated threshold of improvement in pain score in each study. The threshold was determined based on an analysis of the change in pain score that corresponded to “much improved” or “very much improved” on the Patient Global Impression of Change questionnaire.