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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