Ubrogepant

(Ubrelvy®)

Ubrogepant

Drug updated on 10/29/2024

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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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Pain Freedom at 2 Hours Post-Dose: Ubrogepant demonstrated superior efficacy compared to placebo, with comparable effectiveness to rimegepant and lasmiditan but less effectiveness than triptans such as eletriptan, rizatriptan, sumatriptan, and zolmitriptan.
  • Sustained Pain Freedom from 2 to 24 Hours: Ubrogepant was effective for sustained pain freedom but less so than ibuprofen and eletriptan, with rimegepant showing superior outcomes in this category.
  • Freedom from Most Bothersome Symptom at 2 Hours: Ubrogepant was effective but less effective compared to higher doses of lasmiditan; specifically, lasmiditan at 100 mg and 200 mg showed better outcomes.
  • Pain Relief at 2 Hours: Ubrogepant provided comparable pain relief to rimegepant and lasmiditan but was less effective than triptans, which demonstrated better outcomes for pain relief within the same timeframe.
  • General Safety Profile: Ubrogepant was generally well-tolerated, with the incidence of adverse events comparable to placebo; however, a higher incidence of adverse events was observed at the 100 mg dose compared to the 50 mg dose. It exhibited a better tolerability profile than lasmiditan and rimegepant, especially concerning neurological adverse events such as dizziness and somnolence.
  • Adverse Events: Common adverse events associated with ubrogepant included nausea, dry mouth, and somnolence, with increased adverse events at the 100 mg dose. In comparison, lasmiditan presented the highest risk of adverse events, including dizziness and fatigue, while rimegepant had fewer adverse events than lasmiditan but more than ubrogepant.
  • Safety in Specific Populations: Safety outcomes for ubrogepant were consistent between participants using preventive medications and those not using them, indicating no significant interaction or added risk. No serious treatment-related adverse events were reported in long-term safety trials of ubrogepant.
  • Population Types and Gender Considerations: All studies focused on adults aged 18 years and older diagnosed with migraine, with over 80% of participants being female. Efficacy and safety outcomes for ubrogepant were similar in users and non-users of preventive medications, indicating its safe use alongside such treatments. The predominance of female participants suggests a need for further studies to confirm the effectiveness and safety of ubrogepant across different age groups and in male populations.

Product Monograph / Prescribing Information

Document TitleYearSource
Ubrelvy (ubrogepant) Prescribing Information.2023AbbVie Inc., North Chicago, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative effects of drug interventions for the acute management of migraine episodes in adults: systematic review and network meta-analysis2024BMJ (Clinical Research Ed.)
Comparison of effectiveness and safety of lasmiditan and CGRP-antagonists for the acute treatment of migraine in adults: systematic review and network meta-analysis of randomised trials2024The Journal of Headache and Pain
Efficacy and safety of ubrogepant for migraine: a meta-analysis of randomized controlled studies2024The International 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 literature2023Cephalalgia
Rimegepant, Ubrogepant, and Lasmiditan in the Acute Treatment of Migraine Examining the Benefit-Risk Profile Using Number Needed to Treat/Harm2022The Clinical Journal of Pain
Relative efficacy of lasmiditan versus rimegepant and ubrogepant as acute treatments for migraine: network meta-analysis findings2022The Journal of Headache and Pain
Ubrogepant Is Safe and Efficacious in Participants Taking Concomitant Preventive Medication for Migraine: A Pooled Analysis of Phase 3 Trials2022Advances in Therapy
Comparative efficacy and safety of rimegepant, ubrogepant, and lasmiditan for acute treatment of migraine: a network meta-analysis2022Expert Review of Pharmacoeconomics & Outcomes Research
Comparison of New Pharmacologic Agents With Triptans for Treatment of Migraine: A Systematic Review and Meta-analysis2021JAMA Network Open
Ditans vs Gepants: A Systematic Review and Indirect Network Meta-Analysis for Comparative Analysis of Efficacy and Safety2021Neurology India, 69(Supplement)
Calcitonin gene-related peptide receptor antagonist ubrogepant for the treatment of acute migraine: A meta-analysis2021Medicine
Gepants for abortive treatment of migraine: A network meta-analysis2020Brain and Behavior

Clinical Practice Guidelines