The Food and Drug Administration (FDA) has approved Ubrelvy (ubrogepant tablets; Allergan), the first oral calcitonin gene-related peptide (CGRP) receptor antagonist, for the acute treatment of migraine with or without aura in adults.

The approval was supported by two pivotal phase 3, randomized, double-blind, placebo-controlled trials (ACHIEVE I and ACHIEVE II) that evaluated the efficacy, safety and tolerability of Ubrelvy in adult patients with a history of migraine, with or without aura. Patients were instructed to treat a migraine with moderate to severe headache pain intensity; up to 23% were taking preventive medications for migraine at baseline. 

In both studies, the percentage of patients achieving headache pain freedom and most bothersome symptom (MBS) freedom 2 hours postdose (co-primary end points) was significantly greater among patients treated with Ubrelvy compared with those who received placebo. Moreover, the incidence of photophobia and phonophobia (the most commonly reported symptoms) was reduced following administration of Ubrelvy as compared with placebo. 

With regard to safety, the most common adverse reactions reported were nausea and somnolence. Ubrelvy is contraindicated with concomitant use of strong CYP3A4 inhibitors (ie, ketoconazole, itraconazole, clarithromycin) as co-administration may result in a significant increase in ubrogepant exposure. 

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The recommended dose of Ubrelvy is 50mg or 100mg taken orally; if needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200mg and the safety of treating more than 8 migraines in a 30-day period has not been established. Dose modification is also required for patients taking concomitant CYP3A4 inhibitors/inducers and BCRP and/or P-gp only inhibitors, as well as in those with severe hepatic or renal impairment. 

The Company expects to launch Ubrelvy in the first quarter of 2020 in 50mg and 100mg strength tablets in unit-dose packets containing 1 tablet. 

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