STUDY DESIGN1-3

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

UBRELVY quickly relieves migraine pain with just one dose1,2

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

Effective relief—whether patients took UBRELVY right away or within 4 hours4

Elimination of migraine headache pain with just one dose2-4

Significantly more patients were pain-free with UBRELVY vs placebo2-4

Pain freedom at 2 hours—co-primary endpoint1‡

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 results1,7

Eliminated the most bothersome migraine-associated symptom at or before 2 hours: 38.7% (UBRELVY 50 mg, n=883), and 37.7% (UBRELVY 100 mg, n=448) vs 27.6% (placebo, n=910) (co-primary endpoint)1,4

FREEDOM FROM MIGRAINE-ASSOCIATED SYMPTOMS WITH ONE DOSE4

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

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

References

1. UBRELVY [package insert]. Madison, NJ: Allergan USA, Inc.; 2019. 2. Lipton RB, Dodick DW, Ailani J et al. Effect of ubrogepant vs placebo on pain from the most bothersome associated symptom in the acute treatment of migraine: the ACHIEVE II randomized clinical trial. JAMA. 2019;322(19):1887-1898. 3. Dodick DW, Lipton RB, Ailani, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 4. Data on file. Allergan. 5. Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial. Headache. 2020;60(1):141-152. 6. Dodick DW, Goadsby PJ, Lu K, Jakata A, Szegedi A, Trugman JM. Ubrogepant achieves early pain relief for the acute treatment of migraine. Poster presented at: 60th Annual Scientific Meeting of the American Headache Society; June 28-July 1, 2018; San Francisco, CA. Poster P103. 7. Lipton RB, Ailani J, Hutchinson S, et al. Efficacy is maintained with long-term intermittent use of ubrogepant for the acute treatment of migraine. Poster presented at: 61st Annual Scientific Meeting of the American Headache Society; November 21-24, 2019; Philadelphia, PA. Poster P135.