|ADVERSE EVENT ≥5%3*||QULIPTA 60 mg QD (n=543)|
|Upper respiratory tract infection||10%|
|Urinary tract infection||5%|
*The majority of the cases were mild, and none were serious.
31/543 patients (5.7%) discontinued due to adverse events.3
REDUCTION IN MIGRAINE DAYS OVER 52 WEEKS WAS CONSISTENT WITH THE PIVOTAL TRIAL1-3
MONTHLY MIGRAINE DAY REDUCTION RANGED FROM 3.8 IN WEEKS 1-4 TO 5.2 IN WEEKS 49-523
These are observations from the 52-week, open-label safety study for which efficacy measures were not an endpoint. 31/543 patients (5.7%) discontinued due to adverse events.3 Data from the open-label 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.
Open-label, Long-term Safety Study
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 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