Ubrogepant

(Ubrelvy®)

Ubrelvy®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 50 mg, 100 mg)
Drug ClassCalcitonin gene-related peptide receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the acute treatment of migraine with or without aura in adults.

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Summary
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  • Ubrelvy (ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults.
  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Ubrogepant 50 mg vs 100 mg: Both doses showed comparable effectiveness in migraine patients across several outcomes, including pain freedom at 2 hours (OR = 0.86; 95% CI = 0.64-1.15; p = 0.310) and sustained pain freedom 2-24 hours (OR = 0.76; 95% CI = 0.54-1.07; p = 0.110).
  • Comparative effectiveness with other drugs: Lasmiditan 200 mg was the most effective for pain freedom at 2 hours, followed by rimegepant and ubrogepant. Lasmiditan 100 mg and 200 mg doses were generally more effective than rimegepant 75 mg and ubrogepant 25 mg and 50 mg.
  • General findings from meta-analyses: Ubrogepant and other CGRP antagonists, including rimegepant and telcagepant, were significantly more effective than placebo for pain freedom and relief at 2 hours. Triptans were generally more effective than ubrogepant, lasmiditan, and rimegepant for achieving pain freedom and relief at 2 hours.
  • Adverse events increased with the 100 mg dose of ubrogepant compared to the 50 mg dose (OR = 0.81; 95% CI = 0.67-0.99; p = 0.040), but no significant difference in serious adverse events was observed (OR = 0.87; 95% CI = 0.40-1.91; p = 0.720).
  • Ubrogepant demonstrated the best overall tolerability compared to lasmiditan and rimegepant, with lasmiditan associated with higher odds of treatment-emergent adverse events, particularly neurological events such as dizziness, nausea, and somnolence.
  • CGRP antagonists, including ubrogepant, had a slightly higher incidence of any adverse events compared to placebo but were safer than triptans concerning primary safety outcomes.
  • Population and Subgroup Considerations: Studies predominantly included female patients (>80%), with a mean age ranging from 37.9 to 45.7 years. Ubrogepant showed efficacy across different dosage levels in episodic migraine patients, with specific correlations noted between dosage and muscle strain, BMI and liver function values, and age with adverse events. Most studies excluded chronic migraine patients, focusing instead on episodic migraine populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Ubrelvy (ubrogepant) Prescribing Information. 2023Allergan USA Inc., Madison, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of ubrogepant for migraine: a meta-analysis of randomized controlled studies.2024International Journal of Neuroscience
Efficacy, safety and indirect comparisons of lasmiditan, rimegepant, and ubrogepant for the acute treatment of migraine: a systematic review and network meta-analysis of the literature.2023Cephalalgia
Relative efficacy of lasmiditan versus rimegepant and ubrogepant as acute treatments for migraine: network meta-analysis findings.2022Journal of Headache and Pain
Comparative efficacy and safety of rimegepant, ubrogepant and lasmiditan for acute treatment of migraine: a network meta-analysis.2022Expert Review of Pharmacoeconomics & Outcomes Research
Safety evaluation of oral calcitonin-gene–related peptide receptor antagonists in patients with acute migraine: a systematic review and meta-analysis.2022European Journal of Clinical Pharmacology
Ubrogepant and rimegepant: systematic review, meta-analysis, and meta-regression of clinical studies.2022Expert Opinion on Drug Safety
Ditans vs Gepants: a systematic review and indirect network meta-analysis for comparative analysis of efficacy and safety.2021Neurology India
Comparative efficacy of oral calcitonin-gene–related peptide antagonists for the treatment of acute migraine: updated meta-analysis.2021Clinical Drug Investigation
Calcitonin gene-related peptide receptor antagonist ubrogepant for the treatment of acute migraine. 2021Medicine
Comparison of new pharmacologic agents with triptans for treatment of migraine: a systematic review and meta-analysis.2021Journal of the American Medical Association
Safety and efficacy of ubrogepant for the acute treatment of episodic migraine: a meta-analysis of randomized clinical trials.2020CNS Drugs
Gepants for abortive treatment of migraine: A network meta-analysis.2020Brain and Behavior
Network meta-analysis of calcitonin gene-related peptide receptor antagonists for the acute treatment of migraine.2019Frontiers in Pharmacology

Clinical Practice Guidelines