12-WEEK SAFETY PROFILE
QULIPTA® 12-week safety
Safe and well tolerated across patients
≥ 2% for QULIPTA and greater than placebo1*
|QULIPTA 10 mg QD
|QULIPTA 30 mg QD
|QULIPTA 60 mg QD
*QULIPTA 10 mg and QULIPTA 30 mg data are specific to two EM trials; QULIPTA 60 mg data are pooled from one CM trial and two EM trials.
Studies included patients with a history of3:
- Gastrointestinal disorders (31%)
- Psychiatric disorders (41%)
In all studies, a decrease in weight was observed1:
The proportion of patients with a weight decrease of at least 7% at any point was 5.3% for QULIPTA 60 mg QD, 3.2% for QULIPTA 30 mg QD, 3.8% for QULIPTA 10 mg QD, and 2.5% for placebo.1
CM=chronic migraine; EM=episodic migraine.
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 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
52-WEEK SAFETY PROFILE
Open-label, long-term safety study
Well tolerated across 52 weeks
|ADVERSE EVENTS ≥5%3||QULIPTA 60 mg QD
|Upper respiratory tract infection||10%|
|Urinary tract infection||5%|
- Mean age: 42.5 years (range 18-78)
- 88.3% Female
- 76.8% White
- 15.7% Hispanic or Latino
A decrease in weight was observed3:
The proportion of patients with a weight decrease of at least 7% at any point was 24.1% for QULIPTA 60 mg QD.
LIMITATIONS: These are observations from the 52-week, open-label safety study. 31/543 patients (5.7%) discontinued due to adverse events.3 Data from this 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.
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
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