PHASE 3 CLINICAL TRIALS

ACHIEVE PIVOTAL TRIALS DESIGN^1-4

UBRELVY® was evaluated in two randomized, double-blind, placebo-controlled, multicenter trials, ACHIEVE I (UBRELVY 50 mg or 100 mg) and ACHIEVE II (UBRELVY 50 mg). The studies 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 to 8 migraine attacks of moderate to severe pain in each of the previous 3 months. Patients received either 50 mg (n=886) or 100 mg (n=448), or placebo (n=912). Data were pooled for the 50 mg analysis. A second dose of UBRELVY or rescue medication could be taken from 2 to 48 hours after the initial dose of UBRELVY. Co‑primary endpoints at 2 hours for UBRELVY vs placebo were pain freedom (50 mg: 21% [182/886] or 100 mg: 21% [95/448] vs 13% [119/912]) and freedom from most bothersome symptom, defined as photophobia, phonophobia, or nausea (50 mg: 39% [342/883] vs 28% [251/910] or 100 mg: 38% [169/448] vs 28% [126/454]).

PRODROME STUDY DESIGN

UBRELVY is the only acute treatment for migraine that has demonstrated data in the prodrome phase in a phase 3, double-blind, placebo-controlled trial.^5,6

Key inclusion criteria^5,6:

This study was conducted for patients with migraine who recognized prodrome symptoms of a migraine attack 1 to 6 hours before the headache phase. Patients were between 18 and 75 years of age with ≥1-year history of migraine (with or without aura), consistent with a diagnosis according to the ICHD-3. Migraine onset occurred before 50 years of age. Migraine attacks occurred 2 to 8 times/month with moderate to severe headache, typically separated by 48 hours and lasting between 4 and 72 hours if untreated or treated unsuccessfully. Patients had current or past use of ≥1 prescription medication for the acute treatment of migraine or preventive treatment. Patients were eligible for randomization in the double-blind treatment period if ≥75% of 4 to 16 migraine attacks with prodrome symptoms led to headache pain (of any intensity) within 1 to 6 hours or, if only 3 migraine attacks with prodrome symptoms were identified, all were required to lead to headache 100% of the time.

HCP interview questions to determine patient eligibility⁶:

• “Do you have ‘warning signs’ that tell you when a headache is about to start? Describe them for me.”
• “Considering all your migraine headaches, what percentage are preceded by prodrome/warning symptoms?”
• “After experiencing your prodrome symptoms, how reliably does a headache occur within 1 to 6 hours?*”

77% of patients (n=911) reliably identified their prodrome symptoms, which included, but was not limited to, sensitivity to light (57%), fatigue (50%), neck pain (42%), sensitivity to sound (34%), and dizziness (28%).^5*†

After meeting eligibility criteria, randomized patients (n=518) treated 2 separate migraine attacks with pre-headache symptoms (≥7 days apart), one with UBRELVY 100 mg and one with placebo.^5‡

Participant flow^5,6:

1087 patients were screened for eligibility and 479 patients discontinued due to screening failure, including failure to meet inclusion criteria (317) and failure to screen due to a qualifying event (290).

ICHD-3=International Classification of Headache Disorders 3.
*Reliable identification was defined as at least 75% of the time.⁵

^†Based on the 920 participants who entered e-diary data and included a total of 4802 qualifying pre-headache events during the screening period. The number of pre-headache symptoms is not the same as the number of pre-headache qualifying events.^5,6

^‡The 50 mg dose was not assessed. Patients were not allowed to administer a second dose.⁶

References: 1. UBRELVY. Package insert. AbbVie Inc; 2023. 2. Lipton RB, Dodick DW, Ailani J, et al. Effect of ubrogepant vs placebo on pain and 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 J, et al. Ubrogepant for the treatment of migraine. N Engl J Med. 2019;381(23):2230-2241. 4. Hutchinson S, Dodick DW, Treppendahl C, et al. Ubrogepant for the acute treatment of migraine: pooled efficacy, safety, and tolerability from the ACHIEVE I and ACHIEVE II phase 3 randomized trials. Neurol Ther. 2021;10(1):235-249. 5. Dodick DW, Goadsby PJ, Schwedt TJ, et al. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023;402(10419):2307-2316. 6. Data on file. AbbVie Inc.