Abstract Details

Title Long-Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine

Topic Headache

Presentation(s) P2 - Poster Session 2 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-009

Objective Evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine.

Background Ubrogepant is a novel, oral CGRP receptor antagonist in development for the acute treatment of migraine. Intermittent, long-term use is anticipated in adults with migraine; therefore, long-term safety evaluation is needed.

Design/Methods Phase 3, multicenter, randomized, open-label, 52-week extension trial. Adults with migraine with or without aura were randomized 1:1:1 to usual care, ubrogepant 50-mg, or ubrogepant 100-mg. Randomization was blinded for the ubrogepant arms. Safety and tolerability were assessed.

Results In total, 1254 participants were randomized; 1230 in the safety population. Participants’ mean age was 42 years, 90% female, 84% White, average BMI=30. Throughout the study, 22,454 migraine attacks were treated with 31,968 doses of ubrogepant. Treatment-emergent adverse events (AEs) reported: 271/417 (65%) usual care, 268/404 (66%) ubrogepant 50-mg, 297/409 (73%) ubrogepant 100-mg; most common was upper respiratory tract infection (140/1230, 11%), with a similar incidence observed across treatments. Treatment-related AEs: 42/404 (10%) ubrogepant 50-mg, 43/409 (10%) ubrogepant 100-mg. Serious AEs: 17/417 (4%) usual care, 9/404 (2%) ubrogepant 50-mg, 12/409 (3%), ubrogepant 100-mg; one considered related by the investigator (ubrogepant 50-mg; sinus tachycardia). 20 cases of ALT/AST ≥3x ULN were reported and adjudicated by an independent panel of liver experts blinded to treatment. 17 of 20 cases (4 usual care, 3 ubrogepant 50-mg, 10 ubrogepant 100-mg) were adjudicated as Unlikely Related based on plausible alternative etiology/confounding factor(s). Two cases (both ubrogepant 50-mg) were adjudicated as Possibly Related to study medication and one case (ubrogepant 100-mg) was adjudicated as Probably Related; however, confounding factors were noted. All cases were asymptomatic with no concurrent bilirubin elevation. ALT/AST elevations resolved in those who continued dosing.

Conclusions Intermittent use of ubrogepant for the acute treatment of migraine over 1 year was well-tolerated with no identified safety concerns.

Authors/Disclosures
Jessica Ailani, MD, FAAN (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 AAN interests or activities.
Susan Hutchinson	Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Allergan Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Currax Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for electroCore. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $0-$499 for serving as a Consultant for Lundbeck Pharmaceutical. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Teva. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Upsher Smith. Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan . Susan Hutchinson has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/AbbVie. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Susan Hutchinson has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Lilly Pharmaceutical . Susan Hutchinson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva . Susan Hutchinson has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . Susan Hutchinson has received publishing royalties from a publication relating to health care.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine)	Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.
Kerry L. Knievel, DO (Barrow Neurological Institute)	Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Knievel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Pfizer. Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven . Dr. Knievel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Lundbeck . Dr. Knievel has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Headache Cooperative of the Pacific . The institution of Dr. Knievel has received research support from Abbvie .
Sung Y. Yu	Sung Y. Yu has received personal compensation for serving as an employee of Abbvie. Sung Y. Yu has received stock or an ownership interest from Abbvie.
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, FAAN	Dr. Trugman has received personal compensation for serving as an employee of AbbVie. Dr. Trugman has stock in AbbVie.

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