Powerful Reductions

EPISODIC MIGRAINE

Powerful migraine day reductions that give patients more migraine-free days

Significant reductions across 12 weeks1

Primary endpoint: mean monthly migraine day reduction across 12 weeks1

(4.2 fewer MMD from 7.8 baseline)
vs 33% (2.5 fewer MMD from 7.5 baseline) with placebo1

 

QULIPTA 60 mg (n=222; P<0.001); placebo (n=214)1

Similar percentages were seen with other doses across 12 weeks1:

  • QULIPTA 30 mg: 49% MMD reduction (3.9 fewer MMD from 7.9 baseline) (n=223; P<0.001)1
  • QULIPTA 10 mg: 49% MMD reduction (3.7 fewer MMD from 7.5 baseline) (n=214; P<0.001)1

MMD=Monthly Migraine Days.

Majority of patients achieved a 50% to 100% reduction in monthly migraine days1

Response rates

50%-100% Response Rate

Secondary endpoint:
Percentage of patients who
achieved 50%-100% MMD reduction
across 12 weeks1

 

12-Week Average
QULIPTA 60 mg

61%

of patients

(n=222)
(P<0.001)

vs 29% placebo1 (n=214)

Similar 12-week average percentages were seen with other doses1:

  • 59% for QULIPTA 30 mg (n=223) (P<0.001)
  • 56% for QULIPTA 10 mg (n=214) (P<0.001)

Additional endpoint: 
Percentage of patients who
achieved 50%-100% MMD reduction in
Weeks 1-4, 5-8, 9-122

 

Weeks 9-12
QULIPTA 60 mg

71%

of patients

(n=195)

vs 44% placebo3 (n=196)

Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:

  • Weeks 1-4: 61% for QULIPTA 60 mg (n=221) vs 27% for placebo (n=212)
  • Weeks 5-8: 66% for QULIPTA 60 mg (n=207) vs 47% for placebo (n=204)

LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

75%-100% Response Rate

Additional endpoint:
Percentage of patients who
achieved 75%-100% MMD reduction
across 12 weeks2

 

12-Week Average
QULIPTA 60 mg

38%

of patients

(n=222)

vs 11% placebo3 (n=214)

Similar 12-week average percentages were seen with other doses3:

  • 30% for QULIPTA 30 mg (n=223)
  • 30% for QULIPTA 10 mg (n=214)

Additional endpoint: 
Percentage of patients who achieved 75%-100% MMD reduction in
Weeks 1-4, 5-8, 9-122

 

Weeks 9-12
QULIPTA 60 mg

50%

of patients

(n=195)

vs 21% placebo3 (n=196)

Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:

  • Weeks 1-4: 39% for QULIPTA 60 mg (n=221) vs 10% for placebo (n=212)
  • Weeks 5-8: 41% for QULIPTA 60 mg (n=207) vs 17% for placebo (n=204)

LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

100% Response Rate

Zero Migraine day data

Additional endpoint:
Percentage of patients who
achieved 100% MMD reduction
across 12 weeks2

 

12-Week Average
QULIPTA 60 mg

8%

of patients

(n=222)

vs 1% placebo3 (n=214)

Similar 12-week average percentages were seen with other doses3:

  • 5% for QULIPTA 30 mg (n=223)
  • 8% for QULIPTA 10 mg (n=214)

Additional endpoint: 
Percentage of patients who
achieved 100% MMD reduction in
Weeks 1-4, 5-8, and 9-122

 

Weeks 9-12
QULIPTA 60 mg

28%

of patients

(n=195)

vs 11% placebo3 (n=196)

Similar additional endpoint results were seen in Weeks 1-4 and Weeks 5-83:

  • Weeks 1-4: 19% for QULIPTA 60 mg (n=221) vs 4% for placebo (n=212)
  • Weeks 5-8: 24% for QULIPTA 60 mg (n=207) vs 8% for placebo (n=204)

LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.

CHRONIC MIGRAINE

NOW APPROVED:

Powerful migraine day reductions in chronic migraine

On average, at baseline patients in this study had:

HIGH FREQUENCY
~19 MMD1

PREVENTIVE TREATMENT EXPERIENCE
83% had preventive exposure3

SEVERE DEBILITATION
>15 acute medication use days; ~43 MSQ-RFR score1

MEDICATION OVERUSE
Nearly two-thirds of patients who were studied overused acute medication3

 

Migraine Day Reductions

Primary endpoint: mean monthly migraine day reduction across 12 weeks1

On average, patients got nearly 1 week's worth of migraine-free days back in their lives per month1

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QULIPTA 60 mg: -6.9 days from 19.2 baseline MMD
(n=256) (P<0.001)1

Placebo: -5.1 days from 18.9 baseline MMD
(n=246)1

MMD=Monthly Migraine Days; MSQ-RFR=Migraine-Specific Quality of Life Role Function-Restrictive.

FUNCTION

QULIPTA® has the power to help patients with migraine do more

Improvement in function related to daily social & work-related activities, as measured by MSQ-RFR

Higher scores indicate lesser impact of migraine on daily activities, and increases from baseline indicate improvement.1

 

Secondary endpoint: change from baseline at Week 12 for MSQ-RFR scores1

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EPISODIC: +67% QULIPTA 60 mg (31.3 higher MSQ-RFR score from 46.8 baseline) (n=222) vs +44% placebo (20.5 higher MSQ-RFR score from 46.8 baseline) (n=214) (P<0.001)1

+69% QULIPTA 30 mg (30.5 higher MSQ-RFR score from 44.0 baseline) (n=223; P<0.001)1
+68% QULIPTA 10 mg (30.4 higher MSQ-RFR score from 44.9 baseline) (n=214; P<0.001)1

CHRONIC: +54% QULIPTA 60 mg (23.3 higher MSQ-RFR score from 43.4 baseline) (n=256) vs +39% placebo (17.2 higher MSQ-RFR score from 43.9 baseline) (n=246) (P<0.001)1

Composite endpoint includes:

Work Activities

Concentration

Leisure Activities

Productivity

Ability to
Perform at Work

Social Activities

Relationships

Energy Levels

Overall scales were not designed to assess these components individually.

MSQ-RFR=Migraine-Specific Quality of Life Role Function-Restrictive.

Migraine-Specific Quality of Life Questionnaire version 2.1 Role Function-Restrictive domain scores assess how often migraine impacts function related to daily social and work-related activities over the past 4 weeks, with scores ranging from 0 to 100.1

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