Ubrogepant significantly decreases acute migraine pain

  • Lipton RB & al.
  • JAMA
  • 19 Nov 2019

  • International Clinical Digest
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Takeaway

  • Patients with migraine who received ubrogepant reported significantly greater relief from acute pain at 2 hours than patients who received a placebo.
  • Patients who received a higher 50-mg dose also reported greater relief at 2 hours from the most bothersome migraine symptoms, such as photophobia, phonophobia, and nausea.

Why this matters

  • Although there are a number of medications available to treat acute migraine pain, some patients cannot take them because of contraindications.

Study design

  • Phase 3 (ACHIEVE II), double-blind, placebo-controlled, parallel-group study.
  • Patients with migraine were randomly assigned to receive ubrogepant 50 mg (n=562), 25 mg (n=561), or placebo (n=563).
  • Funding: Allergan plc.

Key results

  • Percentage of patients relieved from pain at 2 hours with ubrogepant vs placebo (14.3% of patients):
    • 50 mg: 21.8% (OR, 1.62; absolute difference [AD], 7.5%; Padjusted=.01).
    • 25 mg: 20.7% (OR, 1.56; AD, 6.4%; Padjusted=.03).
  • Absence of most bothersome (included photophobia, phonophobia, and nausea) migraine-associated symptom at 2 hours with ubrogepant vs placebo (27.4% patients):
    • 50 mg: 38.9% (OR, 1.65; AD, 11.5%; Padjusted=.01).
    • 25 mg: 34.1% (OR, 1.37; AD, 6.7%; Padjusted=.07).
  • Common adverse events noted with ubrogepant doses 50 mg, 25 mg, and placebo were:
    • nausea (2.0%, 2.5%, and 2.0%, respectively) and
    • dizziness (1.4%, 2.1%, and 1.6%, respectively).

Limitations

  • Single-attack trial.

Coauthored with Chitra Ravi, MPharm