- The US FDA has approved ubrogepant for the treatment of acute migraine with or without aura in adults.
Why this matters
- Ubrogepant is the first calcitonin gene-related peptide receptor antagonist approved for this indication.
- Recommended dosage is 50 or 100 mg taken orally, with a second dose at least 2 hours after initial dose, if needed.
- It is not indicated for the preventive treatment of migraine.
- Ubrogepant should not be used with strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin).
- Approval was based on 2 randomized, double-blind, placebo-controlled phase 3 trials (ACHIEVE I and ACHIEVE II):
- 1439 adults with a history of migraine.
- Freedom from pain at 2 hours significantly higher with ubrogepant (ACHIEVE I: P=.002 at 50 mg and P<.0001 at mg achieve ii: p=".007).</li">
- Freedom from most bothersome symptoms significantly higher with ubrogepant (ACHIEVE I: P<.001 at and mg achieve ii: p>