(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:
MMD=Monthly Migraine Days.
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
vs 29% placebo1 (n=214)
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
vs 44% placebo3 (n=196)
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
vs 11% placebo3 (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
vs 21% placebo3 (n=196)
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
vs 1% placebo3 (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
vs 11% placebo3 (n=196)
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.
NOW APPROVED:
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
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.
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
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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INDICATION
QULIPTA® (atogepant) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.
WARNINGS AND PRECAUTIONS
Cases, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.
ADVERSE REACTIONS
The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
DRUG INTERACTIONS
Dose modifications are recommended when using the following:
In chronic migraine, avoid use with strong CYP3A4 inhibitors or with CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Severe renal impairment or end-stage renal disease: In episodic migraine, 10 mg once daily. In chronic migraine, avoid use.
Avoid use in patients with severe hepatic impairment.
Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.
US-QLP-230380
Please see full Prescribing Information.
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