STUDY DESIGN^1-3

Two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I and II, evaluated the efficacy and safety of UBRELVY for the acute treatment of a single migraine attack of moderate or severe intensity in adults with a history of migraine, with or without aura, who had 2-8 migraine attacks of moderate to severe pain in each of the previous 3 months. Patients in trials were 89% female, 82% White, 15% Black, 17% Hispanic or Latino, and the mean age at study entry was 41 years (range of 18-75).

mITT=modified intent-to-treat.

A second dose of investigational product or rescue medication (triptans, NSAIDs, acetaminophen, ergots, or opioids) could be taken 2 hours after initial dose and up to 48 hours after initial dose of IP.¹

Up to 23% of patients were taking preventive medications for migraine at baseline, including topiramate, onabotulinumtoxinA, propranolol, and amitriptyline.⁴

Co-primary endpoints¹:

• Pain freedom: defined as reduction in headache severity from moderate or severe pain to no pain at 2 hours after initial dosing
• Absence of most bothersome migraine-associated symptom: defined as complete elimination of nausea, photophobia, or phonophobia at 2 hours after initial dosing. Each patient selected their most bothersome migraine-associated symptom immediately prior to treatment

Selected secondary endpoint¹:

• Pain relief: defined as reduction in headache severity from moderate or severe pain to mild or no pain at 2 hours after initial dosing

Long-term safety study

In a 52-week, open-label, phase 3, multicenter, randomized extension trial, patients who completed 1 of 2 phase 3 single-migraine attack trials were randomized to receive either usual care, ubrogepant 50 mg (404 patients took 15,317 doses), or ubrogepant 100 mg (409 patients took 16,432 doses) to treat their migraine attacks over the course of the trial.⁵

New UBRELVY quickly relieves migraine pain with just one dose^1,2

Significantly more patients achieved pain relief with UBRELVY vs placebo¹

Pain relief at 2 hours—secondary endpoint¹

*UBRELVY 100 mg was included only in ACHIEVE I. ^†UBRELVY 50 mg and 100 mg (P<0.05).

Significant pain relief was seen at 1 hour with UBRELVY 50 mg vs placebo.⁶

Elimination of migraine headache pain with just one dose^2-4

Significantly more patients were pain-free with UBRELVY vs placebo^2-4

Pain freedom at 2 hours—co-primary endpoint^1‡

Pain freedom over time was an additional efficacy endpoint. ^‡Data collected after rescue or second dose was excluded. ^§UBRELVY 100 mg was included only in ACHIEVE I. ^||UBRELVY 50 mg and 100 mg (P<0.001).

• In a 1-year, open-label trial with more than 31,000 migraine attacks treated, safety and efficacy were consistent with pivotal trial results^1,7

FREEDOM FROM MIGRAINE-ASSOCIATED SYMPTOMS WITH ONE DOSE⁴

Absence of most bothersome symptom at 2 hours—co-primary endpoint^1¶

Most bothersome symptom was defined as photophobia, phonophobia, or nausea.^1,4

^¶Data collected after rescue or second dose was excluded. ^#UBRELVY 100 mg was included only in ACHIEVE I. ^**UBRELVY 50 mg and 100 mg (P<0.05).

Absence of most bothersome symptom over time was an additional efficacy endpoint.

The incidence of photophobia and phonophobia was reduced with UBRELVY 50 mg and 100 mg vs placebo.¹

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