ORILISSA showed proven relief across the 3 most common types of endometriosis pain1

Clinical study design: Two robust similar multicenter, double-blind, randomized, prospective, placebo-controlled Phase 3 trials of 6-month treatment at two doses (N=1686)1,2

Dysmenorrhea

Response rates for dysmenorrhea at month 3 with a 150-mg once-daily dose.1,2

Response rates for dysmenorrhea at month 3 with a 200-mg twice-daily dose.1,2

Response rates vs placebo

Response was defined as clinically meaningful pain reduction and stable or decreased rescue analgesic use.a

Click on clinical endpoint and dose to view results.

ELARIS EM-1 Results1,2,d

Proportion of responders for dysmenorrhea (%)
Co-primary endpoint
Month 3c
20 n=373 46b n=248
  • Placebo
  • 150 mg QD

bP≤0.001 vs placebo

ELARIS EM-2 Results

  150 mg QD Placebo
Co-primary Endpoint
Month 3c
43%b
n=221
23%
n=353

Study EM-2 - dysmenorrhea responder threshold: at least 0.85 point decrease from baseline in dysmenorrhea score

aA responder had a reduction in pain from baseline to the analysis month greater than or equal to a calculated, clinically important threshold of improvement, and also had stable or decreased rescue analgesic use.

cThe co-primary efficacy endpoints were the proportion of responders for dysmenorrhea and pelvic pain not related to menses (NMPP) at month 3 compared with placebo.

dStudy EM-1 dysmenorrhea responder threshold: at least 0.81 point decrease from baseline in dysmenorrhea score.

ELARIS EM-1 Results1,2,d

Proportion of responders for dysmenorrhea (%)
Co-primary endpoint
Month 3c
20 n=373 76b n=244
  • Placebo
  • 200 mg BID

bP≤0.001 vs placebo

ELARIS EM-2 Results

  200 mg BID Placebo
Co-primary Endpoint
Month 3c
72%b
n=225
23%
n=353

Study EM-2 - dysmenorrhea responder threshold: at least 0.85 point decrease from baseline in dysmenorrhea score

aA responder had a reduction in pain from baseline to the analysis month greater than or equal to a calculated, clinically important threshold of improvement, and also had stable or decreased rescue analgesic use.

cThe co-primary efficacy endpoints were the proportion of responders for dysmenorrhea and pelvic pain not related to menses (NMPP) at month 3 compared with placebo.

dStudy EM-1 dysmenorrhea responder threshold: at least 0.81 point decrease from baseline in dysmenorrhea score.

Dysmenorrhea pain reduction at month 6 with 150 mg QD.1-3

Dysmenorrhea pain reduction at month 6 with 200 mg BID1-3

Mean changes from baseline in dysmenorrhea pain scoresa,b,c

Click on clinical endpoint and dose to view results.

ELARIS EM-1 Results1-3

Mean change in dysmenorrhea score
  • Placebo
  • 150 mg QD
Placebo (n) 372 348 329 316 299 288
150 mg (n) 248 232 226 219 202 198

Mean baseline dysmenorrhea score: 2.2 (on a scale of 0 to 3) Graph depicts the mean decrease in score.2

ELARIS EM-3 Extension Results1-4

Mean change in dysmenorrhea score
  • Placebo
  • 150 mg QD
150 mg (N) 148 139 132 128 124 117

Baseline and monthly visit values were based on a 35-day mean. At each month during the extension trial, mean changes from baseline in pain scores for dysmenorrhea and NMPP were captured.

These results were based on an observed analysis and only patients that were on treatment during EM-1 and EM-2 were included in this analysis.

*No placebo-controlled treatment was included in the extension study.

aIn EM-1, the mean change in dysmenorrhea and NMPP score from baseline to month 6 were secondary endpoints.

bIn EM-1, the change in dysmenorrhea and NMPP score from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.

cBaseline and monthly visit values were based on a 35-day mean.

ELARIS EM-1 Results1-3

Mean change in dysmenorrhea score
  • Placebo
  • 200 mg BID
Placebo (N) 372 348 329 316 299 288
200 mg (N) 245 221 213 198 191 182

Mean baseline dysmenorrhea score: 2.2 (on a scale of 0 to 3) Graph depicts the mean decrease in score.2

aIn EM-1, the mean change in dysmenorrhea and NMPP score from baseline to month 6 were secondary endpoints.

bIn EM-1, mean change from baseline in dyspareunia score was evaluted as a secondary endpoint vs. placebo at month 3 and as a non-ranked secondary endpoint at each month (except month 3). Appropriate multiplicity adjustments were not applied to the non-ranked secondary endpoints.

cBaseline and monthly visit values were based on a 35-day mean.

THE DAILY ENDOMETRIOSIS PAIN IMPACT SCALE1,2

3

Severe

2

Moderate

1

Mild

0

None

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 above, and included a functional component for each score.

NMPP
Dyspareunia
View All

Indication and Important Safety Information

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

  • ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).

WARNINGS AND PRECAUTIONS

Bone Loss

  • ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
  • The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
  • Limit the duration of use to reduce the extent of bone loss.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

  • Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

  • Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
  • ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had an increased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
  • Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.

Hepatic Transaminase Elevations

  • In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
  • Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
  • Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.

Reduced Efficacy with Estrogen-Containing Contraceptives

  • Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
  • Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.

ADVERSE REACTIONS

  • The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.

These are not all the possible side effects of ORILISSA.

Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.

US-ORIL-200330

For more information, please click here for full Prescribing Information.

References:

1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377(1):28-40. 3. Data on file. ABVRRTI66651. 4. Surrey E, Taylor HS, Giudice L, et al. Long-term outcomes of elagolix in women with endometriosis: results from two extension studies. Obstet Gynecol. 2018;132(1):147-160.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known...

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with osteoporosis or severe hepatic impairment...

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known...

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with osteoporosis or severe hepatic impairment...

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

Indication and Important Safety Information

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

  • ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).

WARNINGS AND PRECAUTIONS

Bone Loss

  • ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
  • The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
  • Limit the duration of use to reduce the extent of bone loss.

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

  • Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

  • Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
  • ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had an increased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
  • Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.

Hepatic Transaminase Elevations

  • In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
  • Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
  • Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.

Reduced Efficacy with Estrogen-Containing Contraceptives

  • Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
  • Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.

ADVERSE REACTIONS

  • The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.

These are not all the possible side effects of ORILISSA.

Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.

US-ORIL-200330

For more information, please click here for full Prescribing Information.