Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 50 mg, 100 mg) |
Drug Class | Calcitonin 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Ubrelvy (ubrogepant) Prescribing Information. | 2023 | Allergan USA Inc., Madison, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The American Headache Society Consensus Statement: update on integrating new migraine treatments into clinical practice. | 2021 | Headache |