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Abstract Details

An Optional Second Dose of Ubrogepant is Effective in Achieving 2-Hour Pain Freedom in the Acute Treatment of Migraine
Headache
P2 - Poster Session 2 (8:00 AM-9:00 AM)
7-001

Evaluate efficacy of a second dose of ubrogepant for the acute treatment of migraine.
Ubrogepant is an oral CGRP receptor antagonist in development for the acute treatment of migraine. Two doses of acute treatment separated over time is sometimes needed for migraine management.
ACHIEVE-I (NCT02828020) and ACHIEVE-II (NCT02867709) were single-attack, Phase 3 trials. Adults with a history of migraine, with/without aura were randomized 1:1:1 to placebo or ubrogepant (50mg or 100mg, ACHIEVE-I; 25mg or 50mg, ACHIEVE-II). An optional second dose was allowed starting 2 hours post-initial dose if pain was still moderate. Participants initially randomized to ubrogepant were re-randomized to placebo or ubrogepant; those initially randomized to placebo received placebo for the second dose. Data for ubrogepant-50mg and placebo were pooled for this analysis. Treatment comparisons were based on those who took the same initial dose.
Participants’ (n=3358 randomized) mean age was 41 years; the majority were female and white. Of those who took an optional second dose of study medication (n=1144), a significantly higher proportion achieved 2-hour pain freedom with an optional second dose of ubrogepant-50mg (n=53/156, 34% pooled; OR: 2.20 [95%CI: 1.26, 3.85], p=0.0057) versus ubrogepant-50mg/placebo (n=25/131, 19% pooled). Of those who achieved 2-hour pain relief post-initial dose, a significantly higher proportion achieved pain freedom post-optional second dose of ubrogepant-50mg (n=41/75, 55% pooled; OR: 2.64 [95%CI: 1.27, 5.49] p=0.0091) versus ubrogepant-50mg/placebo (n=19/57, 33% pooled). Higher response rates were also observed following an optional second dose of ubrogepant-25mg and -100mg; however, differences were not significant. The proportion of participants reporting adverse events after 2 doses of ubrogepant was similar across treatment groups (8%-15%) and comparable to placebo/placebo (12%).
Ubrogepant is the first and only treatment to demonstrate statistically higher rates of pain freedom at second dose compared to placebo. No safety concerns were identified following 2 doses of ubrogepant.
Authors/Disclosures
Jessica Ailani, MD, FÂ鶹´«Ã½Ó³»­ (Medstar Georgetown Neurology)
PRESENTER 		Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Andrew M. Blumenfeld, MD, FÂ鶹´«Ã½Ó³»­ (Cedars Sinai) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.
Bradley M. Klein, MD (Neurology Group of Bergen County, P.A.) No disclosure on file
Michelle Finnegan Michelle Finnegan has received personal compensation for serving as an employee of AbbVie.
No disclosure on file
No disclosure on file
Joel M. Trugman, MD, FÂ鶹´«Ã½Ó³»­ Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.