- Ubrogepant, an oral calcitonin gene-related peptide receptor antagonist, alleviated the pain and most bothersome symptoms of migraine attacks.
Why this matters
- Existing acute treatments have contraindications, limited effectiveness.
- Pain freedom at 2 hours:
- 14.3% with placebo.
- 21.8% with ubrogepant 50 mg (absolute difference, 7.5%; P=.01).
- 20.7% with ubrogepant 25 mg (absolute difference, 6.4%; P=.03).
- Absence of most bothersome associated symptom at 2 hours:
- 27.4% with placebo.
- 38.9% with ubrogepant 50 mg (absolute difference, 11.5%; P=.01).
- 34.1% with ubrogepant 25 mg (absolute difference, 6.7%; P=.07).
- Most common adverse events within 48 hours:
- Nausea (placebo, 2.0%; 50 mg, 2.0%; 25 mg, 2.5%).
- Dizziness (placebo, 1.6%; 50 mg, 1.4%; 25 mg, 2.1%).
- Multicenter phase 3 randomized controlled trial among 1686 adults with migraine, with or without aura, having 2-8 migraine attacks monthly (ACHIEVE II trial).
- Randomization: ubrogepant 50 mg, ubrogepant 25 mg, placebo for single migraine attack of moderate or severe pain intensity.
- Main outcomes: pain freedom, absence of patient-designated most bothersome migraine-associated symptom (photophobia, phonophobia, or nausea).
- Funding: Allergan PLC.
- Treatment not initiated until headache pain moderate or severe.
- Efficacy in subsequent attacks not assessed.
- Adverse events, tolerability assessed after single use.