DAYS ARE POSSIBLE
QULIPTA helps give your patients that forget-you-get migraine feeling. Across 12 weeks, QULIPTA 60 mg reduced attacks for both episodic and chronic migraine patients.
EM primary endpoint: Significant -4.2 monthly migraine day reduction from 7.8 baseline (n=222; P<0.001) vs -2.5 from 7.5 baseline for placebo (n=214)
CM primary endpoint: Significant -6.9 monthly migraine day reduction from 19.2 baseline (n=256; P<0.001) vs -5.1 from 18.9 baseline for placebo (n=246)
The only oral CGRP treatment proven to prevent both episodic and chronic migraine
NOW APPROVED FOR CHRONIC MIGRAINE
Across 12 weeks with QULIPTA® 60 mg:
PROVEN EFFICACY IN PATIENTS WITH EPISODIC AND CHRONIC MIGRAINE1
- EM primary endpoint: Significant -4.2 migraine day reduction from 7.8 baseline (n=222) vs -2.5 from 7.5 baseline for placebo (n=214); P<0.0011‡
- CM primary endpoint: Significant -6.9 migraine day reduction from 19.2 baseline (n=256) vs -5.1 from 18.9 for placebo (n=246); P<0.0011§
MAJORITY OF EM PATIENTS (61%) TAKING QULIPTA 60 mg ACHIEVED A 50% TO 100% REDUCTION IN MONTHLY MIGRAINE DAYS1‡
- Up to 100% reduction achieved
LIMITATIONS: In the 12-week EM pivotal study, 100% response rate was a pre-specified, non-ranked endpoint and was not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
Learn more about powerful migraine day reductions.
With QULIPTA® 60 mg:
MIGRAINE DAY REDUCTIONS CONTINUED ACROSS 12 WEEKS1‡
- Reductions observed as early as Day 1 after the first dose and Week 13
REDUCTIONS OBSERVED ACROSS 52 WEEKS3¶
- In the 12-week EM pivotal study, Day 1 after the first dose and Week 1 were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
- Data from the 52-week EM open-label safety study have limitations as the study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial. Results should be interpreted with these factors in mind.
Learn more about continuous control.
Across 12 weeks with QULIPTA®:
- The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence1
See the safety profile of QULIPTA.
Episodic migraine study design (ADVANCE; Phase 2b/3 Dose-finding Study)
Two randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the efficacy and safety of QULIPTA® for 12 weeks in patients who were experiencing 4 to 14 migraine days per month. Patients in trials were 88% female, 80% White, 17% Black, and 12% Hispanic or Latino ethnicity, and the mean age at study entry was 41 years (range 18-74 years). The studies excluded patients with myocardial infarction, stroke, or transient ischemic attacks within 6 months prior to screening.1,2
Chronic migraine study design (PROGRESS)
A randomized, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy and safety of QULIPTA for 12 weeks in patients who were experiencing 15 or more migraine days per month. Patients in trials were 87% female, 60% White, 3% Black, 36% Asian, and 4% Hispanic or Latino ethnicity, and the mean age at study entry was 42 years (range 18-74 years). A subset of patients (11%) was allowed to use one concomitant migraine preventive medication. The study excluded patients with myocardial infarction, stroke, or transient ischemic attacks within 6 months prior to screening.1
Open-label, Long-term Safety Study Design
A multicenter, randomized, open-label, 52-week long-term safety study to evaluate the safety and tolerability of QULIPTA 60 mg in participants who experienced 4 to 14 migraine days per month. Participants were randomized to either QULIPTA 60 mg once daily or oral standard-of-care migraine prevention medication. Efficacy variables for long-term efficacy evaluation were not classified as primary, secondary, or additional endpoints. Efficacy measures were only collected for the QULIPTA group. For the 521 participants in the QULIPTA group in the mITT population, mean age was 42.5 years (range 18 to 78 years), 88.3% were female, 76.8% were White, and 15.7% were of Hispanic or Latino ethnicity.3