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EPISODIC MIGRAINE Continuous Control

12 WEEKS

Continuous control with migraine day reductions across 12 weeks¹

Graph showing 12-week migraine reduction for episodic migraine. The majority of impact occurred within weeks 1-4. Baseline monthly migraine days was, on average, 7.7.

DAY 1 DATA WEEK 1 DATA

EM=episodic migraine; MMD=Monthly Migraine Days.

ADDITIONAL ENDPOINT: DAY 1

Reductions observed as early as Day 1

Additional endpoint:

Day 1

88%

of EM patients

(185/211)

88% of EM patients (185/211) did not have a migraine day on Day 1
after the initial dose vs 75% placebo³ (151/202)*

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.

*Proportion of participants with a migraine day on Day 1 after the first dose: 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.

ADDITIONAL ENDPOINT: WEEK 1

QULIPTA—reductions observed as early as Week 1

Additional endpoint: Week 1

Graph showing a 53% migraine day reduction for EM patients taking Qulipta 60 mg (n=216) vs 15% for placebo (n=211) at week 1.

*Change from baseline in weekly migraine days (WMD): Week 1 QULIPTA 60 mg: -1.03 WMD from 1.93 baseline; Week 1 placebo: -0.29 WMD from 1.88 baseline.

EM=episodic migraine.

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.

EXPLORATORY ENDPOINTS: 52 WEEKS

Open-label, long-term safety study for EM

Reductions observed across 52 weeks

Exploratory endpoint: Change from baseline in MMD across 52 weeks³

Graph showing reduction in monthly migraine days over a 52 week period. Baseline monthly migraine days was, on average, 7.3.

52-week open-label, long-term safety data for EM

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)

Graph of patients who achieved 50%-100% MMD reduction: 60% in weeks 1-4 (n=513). 70% in weeks 9-12 (n=466). 75% in weeks 21-24 (n=417). 81% in weeks 33-36 (n=379). 84% in weeks 49-52 (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)

Graph of patients who achieved 100% MMD reduction: 21% in weeks 1-4 (n=513). 26% in weeks 9-12 (n=466). 38% in weeks 21-24 (n=417). 40% in weeks 33-36 (n=379). 48% in weeks 49-52 (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.

LEARN MORE

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

Hypersensitivity Reactions: 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.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including QULIPTA. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. QULIPTA should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

ADVERSE REACTIONS

The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

US-QLP-250104

Please see full Prescribing Information.

This site is intended for U.S. healthcare professionals only.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components of QULIPTA.

INDICATION AND IMPORTANT SAFETY INFORMATION

QULIPTA^® (atogepant) is indicated for the preventive treatment of migraine in adults.

CONTRAINDICATIONS

QULIPTA is contraindicated in patients with a history of hypersensitivity to atogepant or any of the components 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

Hypersensitivity Reactions: 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.

Hypertension (HTN): Development or worsening of pre-existing HTN has been reported following the use of CGRP antagonists, including QULIPTA. Some patients who developed new-onset HTN had risk factors. There were cases requiring initiation of HTN treatment and, in some cases, hospitalization. HTN may occur at any time but was most frequently reported within 7 days of initiation. QULIPTA was discontinued in many of the cases. Monitor patients for new-onset or worsening of pre-existing HTN, and consider whether discontinuation of QULIPTA is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s phenomenon (RP): Development, recurrence, or worsening of pre-existing RP has been reported following the use of CGRP antagonists, including QULIPTA. In cases with small molecule CGRP antagonists, symptom onset occurred a median of 1.5 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms. QULIPTA should be discontinued if signs or symptoms of RP develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of RP should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

ADVERSE REACTIONS

The most common adverse reactions (at least 4% and greater than placebo) are nausea, constipation, and fatigue/somnolence.

Dosage form and strengths: QULIPTA is available in 10 mg, 30 mg, and 60 mg tablets.

US-QLP-250104