If endometriosis pain
has her on the sidelines,
ORILISSA has been prescribed for over 100,000 patients2*
*These data reflect the number of women prescribed since ORILISSA was FDA approved in July 2018. Data sourced as of April 2022.
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis. Limit the duration of use based on the dose and coexisting condition.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in pediatric patients have not been established.
US-ORIL-210045
For more information, please click here for full Prescribing Information.
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file. AbbVie Inc. IQVIA and UBC/Medvantx. August 2018-April 2022.
Co-primary endpoint: Responder rate for dysmenorrhea at month 31,3*
ELARIS EM-2
P≤0.001 vs placebo
Secondary endpoints: Mean dysmenorrhea score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline dysmenorrhea score: 2.2 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.
†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.
‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.
§Baseline and monthly visit values were based on a 35-day mean.
Secondary endpoints: Mean dyspareunia score reduction from baseline to month 3 (ranked) and mean percent reduction over 3 months (non-ranked)1,3,4,6*
Mean baseline dyspareunia score: 1.5 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 3 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Baseline and monthly visit values were based on a 35-day mean.
Co-primary endpoint: Responder rate for NMPP at month 31,3*
ELARIS EM-2
P≤0.01 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
Co-primary endpoint: Responder rate for NMPP at month 31,3*
ELARIS EM-2
P≤0.001 vs placebo
Secondary endpoints: Mean NMPP score reduction from baseline to month 6 (ranked) and mean percent reduction over 6 months (non-ranked)1,3,4,6†
Mean baseline NMPP score: 1.6 (on a scale from 0 to 3)
Mean change in pain score from baseline to month 6 was a ranked secondary endpoint. All other endpoints shown above were non-ranked secondary endpoints and multiplicity adjustments were not applied.
*Assessed from baseline to the analysis month greater or equal to the following calculated, threshold of improvement in pain score in each study: Dysmenorrhea responder thresholds were ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder thresholds were ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2. The threshold was determined based on analysis of the change in pain score corresponding to "much improved" or "very much improved" on the Patient Global Impression of Change Questionnaire.
†Baseline and monthly visit values were based on a 35-day mean.
