Treatment

New CGRP Receptor Antagonist Is Efficacious, Safe for Preventing Migraines

PHILADELPHIA—Atogepant, a novel oral calcitonin-gene–related peptide (CGRP) receptor antagonist, is efficacious, safe, and tolerable for the prevention of migraine in adults, according to a study presented at the American Headache Society’s 61st Annual Scientific Meeting.

Results were presented by David W. Dodick, MD, from Mayo Clinic.

To better understand the effects of antogepant, Dr Dodick and colleagues conducted a multicenter clinical trial that included 834 adults with a history of migraine with or without aura and a history of 4 to 14 migraine days in the 28 days before baseline.

Participants were randomly assigned to placebo or atogepant 10 mg daily, 30 mg daily, 30 mg twice daily, 60 mg daily, or 60 mg twice daily for 12 weeks.

Change in mean monthly migraine days from baseline to follow-up was the primary endpoint.

After 12 weeks of treatment, all groups saw a decline in monthly migraine days, but the largest decrease was seen among patients taking atogepant, 30 mg twice daily:

  • -2.85 monthly migraine days for placebo
  • -4.00 monthly migraine days for atogepant, 10 mg daily
  • -3.76 monthly migraine days for atogepant, 30 mg daily
  • ‑4.23 monthly migraine days for atogepant, 30 mg twice daily
  • -3.55 monthly migraine days for atogepant, 60 mg daily
  • ‑4.14 monthly migraine days for atogepant, 60 mg twice daily

In addition, only 170 treatment-related adverse events were reported, and only 7 participants reported serious adverse events.

“All 5 atogepant treatment arms showed statistically significant, clinically relevant differences from placebo in reductions from baseline in mean monthly migraine days,” the researchers concluded. “Atogepant was well tolerated, with no treatment-related serious [adverse effects].”

—Amanda Balbi

Reference:

Dodick DW. Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study. Paper presented at: American Headache Society 61st Annual Scientific Meeting; July 11-14, 2019; Philadelphia, PA.