Safety
12-WEEK SAFETY PROFILE
QULIPTA® 12-week safety
Safe and well tolerated across patients
ADVERSE REACTIONS
≥ 2% for QULIPTA and greater than placebo1*
| Placebo (n=663) |
QULIPTA 10 mg QD (n=314) |
QULIPTA 30 mg QD (n=411) |
QULIPTA 60 mg QD (n=678) |
|
|---|---|---|---|---|
| Nausea | 3% | 5% | 6% | 9% |
| Constipation | 2% | 6% | 6% | 8% |
| Fatigue/ Somnolence |
4% | 4% | 4% | 5% |
| Decreased appetite |
<1% | 2% | 1% | 3% |
| Dizziness | 2% | 2% | 2% | 3% |
*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
Discontinuation3:
3.1% of patients (21/663) on placebo discontinued due to adverse events vs patients on QULIPTA 10 mg 4.1% (13/314), QULIPTA 30 mg 3.6% (15/411), or QULIPTA 60 mg 3.1% (21/678).
CM=chronic migraine; EM=episodic migraine.
52-WEEK SAFETY PROFILE
Open-label, long-term safety study
Well tolerated across 52 weeks
| ADVERSE EVENTS ≥5%3 | QULIPTA 60 mg QD (n=543) |
|---|---|
| Upper respiratory tract infection | 10% |
| Constipation | 7% |
| Nausea | 6% |
| Urinary tract infection | 5% |
Patient demographics3:
- 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.
Discontinuation3:
5.7% of patients (31/543) discontinued QULIPTA 60 mg due to adverse events.
LIMITATIONS: These are observations from the 52-week, open-label safety study. 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.
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