Ubrogepant approved for adults with acute migraine: FDA

  • Food and Drug Administration

  • Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • 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.

Key points

  • 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>
  • Safety evaluated in 3624 adults who received ≥1 dose of ubrogepant.
  • Nausea, sedation, fatigue, and dry mouth were the most common adverse events.

Prescribing information.