Focus of the Report: This report focuses on the efficacy and safety of the calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant (Ubrelvy) for acute treatment of migraines.

Technology Description: Ubrogepant is approved for the acute treatment of migraine. Ubrogepant is a CGRP receptor antagonist belonging to the gepant drug class. CGRP is a 37-amino acid peptide that binds to a receptor found in cerebrovascular smooth muscle cell membranes, causing vasodilation of blood vessels. CGRP is involved with the pathogenesis of migraine, presumably through its vasodilatory effect. Ubrogepant is a highly selective CGRP receptor antagonist that prevents binding of CGRP to its receptor. Ubrogepant is available as 50 milligram (mg) and 100 mg oral tablets. The recommended dose is 50 mg or 100 mg for acute treatment of migraine. If necessary, a second dose may be taken ≥ 2 hours after the first dose.

Controversy: Available acute therapies for migraine headache may not be effective in all patients, may have contraindications related to cardiovascular conditions, may be poorly tolerated, or may be nonspecific for migraine (Peters, 2019). These shortcomings have prompted a need for new migraine treatments. Ubrogepant is one of several new medications designed to target pathologic causes of migraine; however, it is unclear how it compares with other medications for acute migraine treatment.

Key Questions:

  • Is ubrogepant effective for acute treatment of migraine headaches?

  • How does ubrogepant compare with alternative acute treatments for migraine headaches?

  • Is ubrogepant safe?

  • Have definitive patient selection criteria been identified for ubrogepant?

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