NOW APPROVED

Two effective doses of ORILISSA for moderate to severe endometriosis pain relief1

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


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 BID 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

Tap on clinical endpoint and dose to view results.


Dysmenorrhea pain reduction at month 6 with 150 mg QD.1,2,3

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

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

Tap on clinical endpoint and dose to view results.


Response rates

ELARIS EM-1 Results1,2,d

Proportion of responders for dysmenorrhea (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
20 n=373
46b n=248
  • Placebo
  • 150 mg QD

bP≤0.001 vs placebo

ELARIS EM-1 Results1,2,d

Proportion of responders for dysmenorrhea (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
20 n=373
76b n=244
  • Placebo
  • 200 mg BID

bP≤0.001 vs placebo

Pain scores

ELARIS EM-1 Results1,2,3

dysmenorrhea reduction with use of ORILISSA 150 mg tablets in clinical trials

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

dysmenorrhea reduction with use of ORILISSA 150 mg tablets in clinical trials

Baseline and monthly visit values were based on a 35-day mean.1 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.


  • Placebo
  • 150 mg QD

ELARIS EM-1 Results1-3

dysmenorrhea reduction with use of ORILISSA 200 mg tablets in clinical trials

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

  • Placebo
  • 200 mg BID


ELARIS EM-2 Results

150 mg QDPlacebo
Co-primary EndpointMonth 3c43%bn=22123%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-2 Results

200 mg BIDPlacebo
Co-primary EndpointMonth 3c72%bn=22523%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.



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.1


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.



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.1


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.


Response rates for Non-menstrual Pelvic Pain (NMPP) with 150 mg QD.1,2

Response rates vs placebo

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

Response rates for Non-menstrual Pelvic Pain (NMPP) with 200 mg BID.1,2

Response rates vs placebo

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

Tap on clinical endpoint and dose to view results.


Non-menstrual Pelvic Pain reduction with 150 mg QD at month 6.1,2,3

Non-menstrual Pelvic Pain reduction at month 6 with 200 mg BID1

Mean changes from baseline in Non-menstrual Pelvic Pain (NMPP) pain scoresa,b,c

Tap on clinical endpoint and dose to view results.


Response rates

ELARIS EM-1 Results1,2,e

Proportion of responders for NMPP (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
36 n=373
50b n=248
  • Placebo
  • 150 mg QD

bP≤0.001 vs placebo

ELARIS EM-1 Results1,2,d

Proportion of responders for NMPP (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
36 n=373
55b n=244
  • Placebo
  • 200 mg BID

bP≤0.001 vs placebo

Pain scores

ELARIS EM-1 Results1,2,3

nmpp reduction with use of ORILISSA 150 mg tablets in clinical trials

Mean baseline NMPP score: 1.6 (on a scale of 0 to 3)
Graph depicts the mean decrease in score.2


ELARIS EM-3 Extension Results1-4

dysmenorrhea reduction with use of ORILISSA 150 mg tablets in clinical trials

Baseline and monthly visit values were based on a 35-day mean.1

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.


  • Placebo
  • 150 mg QD

ELARIS EM-1 Results1-3

nmpp reduction with use of ORILISSA 200 mg tablets in clinical trials

Mean baseline NMPP score: 1.6 (on a scale of 0 to 3)
Graph depicts the mean decrease in score.2

  • Placebo
  • 200 mg BID


ELARIS EM-2 Results

150 mg QDPlacebo
Co-primary EndpointMonth 3c50%dn=22137%n=353

Study EM-2 - Non-menstrual Pelvic Pain responder threshold: at least 0.43 point decrease from baseline in Non-menstrual Pelvic Pain 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.

dP≤0.01 vs placebo

eStudy EM-1 - Non-menstrual Pelvic Pain responder threshold: at least 0.36 point decrease from baseline in Non-menstrual Pelvic Pain score.



ELARIS EM-2 Results

200 mg BIDPlacebo
Co-primary EndpointMonth 3c58%bn=22537%n=353

Study EM-2 - Non-menstrual Pelvic Pain responder threshold: at least 0.43 point decrease from baseline in Non-menstrual Pelvic Pain 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 - Non-menstrual Pelvic Pain responder threshold: at least 0.36 point decrease from baseline in Non-menstrual Pelvic Pain score.



aln 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.1


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.



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.1


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.


Dyspareunia pain reduction at month 3 with 200 mg BID1,3

Mean changes from baseline in dyspareunia scoresa,b,c

Tap on clinical endpoint and dose to view results.


Pain scores

ELARIS EM-1 Results

Mean change in dyspareunia score at
month 3 was not statistically significant2

ELARIS EM-I Results1-3

dyspareunia reduction with use of ORILISSA 200 mg tablets in clinical trials

Mean baseline dyspareunia score: 1.6 (on a scale of 0 to 3)
Graph depicts the mean decrease in score.2

  • Placebo
  • 200 mg BID




aIn EM-1, the mean change in dysmenorrhea and NMPP score from baseline to month 3 was a secondary endpoint.

bIn EM-1, mean change from baseline in dyspareunia score was evaluated 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.

c Baseline and monthly visit values were based on a 35-day mean.1


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.


Response rates for dysmenorrhea and NMPP at month 3 with 150 mg QD1,2

Response rates vs placebo

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

Response rates for dysmenorrhea and NMPP at month 3 with 200 mg BID1,2

Response rates vs placebo

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

Tap on clinical endpoint and dose to view results.


Dysmenorrhea and Non-menstrual Pelvic Pain reduction with 150 mg QD1,2,3

Dysmenorrhea, NMPP, and dyspareunia pain scores with 200 mg BID1,3

Mean changes from baseline in mean pain scoresa,b,c,d

Tap on clinical endpoint and dose to view results.


Response rates

ELARIS EM-1 Results1,2,e

Dysmenorrhea

Proportion of responders for dysmenorrhea (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
20 n=373
46b n=248
  • Placebo
  • 150 mg QD

dP≤0.01 vs placebo

NMPP

Proportion of responders for NMPP (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
36 n=373
50b n=248
  • Placebo
  • 150 mg QD

dP≤0.01 vs placebo

bP≤0.001 vs placebo

  • Placebo
  • 150 mg QD

ELARIS EM-1 Results1,2,d

Dysmenorrhea

Proportion of responders for dysmenorrhea (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
20 n=373
76b n=244
  • Placebo
  • 200 mg BID

dP≤0.01 vs placebo

NMPP

Proportion of responders for NMPP (%)

80
60
40
20
0
Co-primary endpoint
Month 3c
36 n=373
55b n=244
  • Placebo
  • 200 mg BID

bP≤0.001 vs placebo dP≤0.01 vs placebo

bP≤0.001 vs placebo

  • Placebo
  • 200 mg BID

Pain scores

ELARIS EM-1 Results1,2,3

Dysmenorrheaa,b

chart dysred 150

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

NMPPa,b

chart nmpred 150

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

Dyspareuniaa,c

Mean change in dyspareunia score at month 3 was not statistically significant


ELARIS EM-3 Extension Results1-4

Dysmenorrhea

chart dysred 150 ext

NMPP

chart nmpred 150 ext

 

Baseline and monthly visit values were based on a 35-day mean.1 At each month during the extension trial, mean changes from baseline in pain scores for dysmenorrhea and NMPP were captured.

The 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.


  • Placebo
  • 150 mg QD

ELARIS EM-1 Results1-3

Dysmenorrheaa,b

chart dysred 200

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

NMPPa,b

chart nmpred 200

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

Dyspareuniaa,c

chart reured 200

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

  • Placebo
  • 200 mg BID


ELARIS EM-2 results


Dysmenorrhea

150 mg QDPlacebo
Co-primary EndpointMonth 3c43%bn=22123%n=353

NMPP

150 mg QDPlacebo
Co-primary EndpointMonth 3c50%dn=22137%n=353

Dyspareunia

Not statistically significant

Response rate for dyspareunia was a non-ranked secondary endpoint.

Dysmenorrhea responder threshold: at least 0.85 point decrease from baseline in dysmenorrhea score; Non-menstrual Pelvic Pain responder threshold: at least 0.43 point decrease from baseline in Non-menstrual Pelvic Pain 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.

dP≤0.01 vs placebo

eStudy EM-1 dysmenorrhea responder threshold: at least 0.81 point decrease from baseline in dysmenorrhea score; Non-menstrual Pelvic Pain responder threshold: at least 0.36 point decrease from baseline in Non-menstrual Pelvic Pain score.



ELARIS EM-2 results were consistent with those observed in ELARIS EM-1


Dysmenorrhea

200 mg BIDPlacebo
Month 3c72%bn=22523%n=353

NMPP

200 mg BIDPlacebo
Month 3c58%bn=22537%n=353

Dyspareunia*

Not statistically significant

Response rate for dyspareunia was a non-ranked secondary endpoint.

Study EM-2 - dysmenorrhea responder threshold: at least 0.85 point decrease from baseline in dysmenorrhea score; Non-menstrual Pelvic Pain responder threshold: at least 0.43 point decrease from baseline in Non-menstrual Pelvic Pain 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; Non-menstrual Pelvic Pain responder threshold: at least 0.36 point decrease from baseline in Non-menstrual Pelvic Pain score.



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.

cIn EM-1, mean change from baseline in dyspareunia score was evaluated as a secondary endpoint vs. placebo at month 3 and as a non-ranked secondary endpoint at each month (except month 3).

dBaseline and monthly visit values were based on a 35-day mean.1

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.

cIn EM-1, mean change from baseline in dyspareunia score was evaluated 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.

dBaseline and monthly visit values were based on a 35-day mean.1


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.