EM=episodic migraine; MMD=Monthly Migraine Days.
Additional endpoint:
Day 1
88% of EM patients (185/211) did not have a migraine day on Day 1 vs 75% placebo3 (151/202)* after the initial dose
LIMITATIONS: The additional endpoints were pre-specified, non-ranked endpoints and were not adjusted for multiplicity. Therefore, treatment differences cannot be regarded as statistically significant.
*Day 1 data: 12.3% (26/211) of QULIPTA 60 mg patients had a migraine day vs 25.2% (51/202) of placebo patients.3
EM=episodic migraine.
Open-label, long-term safety study for EM
Exploratory endpoint: Change from baseline in MMD across 52 weeks3
Exploratory endpoint: Percentage of patients who achieved 50%-100% MMD reduction at specified intervals3
In Weeks 49-52
84%
of patients achieved
50%-100% MMD reduction3
(n=335)
Exploratory endpoint: Percentage of patients who achieved 100% MMD reduction at specified intervals3
In Weeks 49-52
48%
of patients achieved
100% MMD reduction3
(n=335)
LIMITATIONS: These are observations from the 52-week, open-label safety study for which efficacy measures were not an endpoint. 31/543 EM 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.
EM=episodic migraine; mITT=modified intention-to-treat; MMD=Monthly Migraine Days.
See the safety profile of QULIPTA.
INDICATION
QULIPTA® (atogepant) is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.
WARNINGS AND PRECAUTIONS
Cases, including anaphylaxis, dyspnea, rash, pruritus, urticaria, and facial edema, have been reported with use of QULIPTA. Hypersensitivity reactions can occur days after administration. If a hypersensitivity reaction occurs, discontinue QULIPTA and institute appropriate therapy.
ADVERSE REACTIONS
The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.
DRUG INTERACTIONS
Dose modifications are recommended when using the following:
In chronic migraine, avoid use with strong CYP3A4 inhibitors or with CYP3A4 inducers.
USE IN SPECIFIC POPULATIONS
Severe renal impairment or end-stage renal disease: In episodic migraine, 10 mg once daily. In chronic migraine, avoid use.
Avoid use in patients with severe hepatic impairment.
Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.
US-QLP-230380
Please see full Prescribing Information.
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