Two robust similar multicenter, double-blind, randomized, prospective, placebo-controlled Phase 3 trials of 6-month treatment at 2 doses.
The studies enrolled women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain.
Two blinded extension studies were conducted, EM-3 and EM-4, in which the subjects who were originally on ORILISSA in the controlled studies EM-1 and EM-2 were maintained on their dose for an additional 6 months.3 Subjects who were originally on placebo in the controlled studies EM-1 and EM-2 were re-randomized to either ORILISSA 150 mg QD or 200 mg BID dose groups.
*Women were defined as responders only 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.
ELARIS EM-1 and ELARIS EM-2 asked patients to assess and record their pain and its effect on their activities every day using the Daily Endometriosis Pain Impact Scale. The scale allowed patients to report their pain levels over the previous 24-hour period using the scoring system below, and included a functional component for each score.
Women were defined as responders if they experienced clinically meaningful* pain reduction and stable or decreased rescue analgesic use for endometriosis 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.
Severe pain. I had great difficulty doing the things I usually do.
Moderate discomfort or pain. I had some difficulty doing the things I usually do.
Mild discomfort but I was easily able to do the things I usually do.
I avoided sexual intercourse because of pain.
Intercourse was interrupted due to pain.
I was able to tolerate the discomfort during sexual intercourse.
No discomfort during sexual intercourse.
I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse.
At screening, 88% of women reported receiving at least 1 medication for endometriosis related symptoms prior to the trial. The most common previously used medication classes (>15% prevalence) were hormonal contraceptives (49%), anti-inflammatory products (36%), gonadotropin-releasing hormone analogues (26%), and opioids (18%).
*This list is not all-inclusive.
of women who completed the pivotal studies enrolled in the extension studies for an additional 6-month treatment period.6
Characteristics were consistent across treatment groups and studies
Age, mean (SD) years
BMI, mean (SD) kg/m2
Months since surgical diagnosis, mean (SD)
Baseline use of any analgesics, NSAID and opioid (%)
Baseline use of analgesics, NSAID only/opioid only (%)
GnRH agonist (%)
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