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Abstract Details

Safety and Tolerability of Ubrogepant Within Various Demographic and Clinical Characteristic Subgroups
Headache
Headache Posters (7:00 AM-5:00 PM)
040
To evaluate the safety and tolerability of ubrogepant across various demographic and clinical characteristic subgroups.
Ubrogepant is an oral CGRP receptor antagonist approved by the FDA for the acute treatment of migraine in adults. Demographic and clinical characteristics vary among people with migraine; therefore, there is a need to understand the impact of these parameters on the safety and tolerability of ubrogepant.
The ACHIEVE trials were multicenter, randomized, double-blind, placebo-controlled, single-attack, phase 3 trials. Adults with a history of migraine with or without aura were randomized 1:1:1 to placebo or ubrogepant (50 mg or 100 mg in ACHIEVE I; 25 mg or 50 mg in ACHIEVE II). Adverse events (AEs) were evaluated within 48 hours and at 30 days post dose by age, BMI, race, sex, and use of anxiety/depression medication. Data were pooled from the ACHIEVE I and II trials for ubrogepant 50 mg and placebo for this analysis.

There were 1938 participants included in the pooled safety population (N=984 placebo, N=954 ubrogepant 50 mg). Rates of treatment-emergent AEs (TEAEs) within 48 hours post dose in the pooled ubrogepant 50 mg group were 12.2% vs 8.4% in those <50 vs ≥50 years of age; 14.1% vs 10.9% in males vs females; 12.0% vs 7.5% in whites vs non-whites; 10.8% vs 11.7% in those with BMI <30 vs BMI ≥30; and 9.5% vs 11.7% in those with vs without anxiety/depression medication use. No notable differences were seen in treatment-related AEs, serious AEs, or in AE rates within 30 days post dose within the subgroups. In the overall pooled safety population, the most commonly reported TEAE within both 48 hours and 30 days post dose was nausea (2%).
Safety and tolerability of ubrogepant were consistent within the various demographic and clinical characteristic subgroups, with no new safety signals identified.
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.
Brad C. Klein, MD, MBA, FÂ鶹´«Ã½Ó³»­ (Abington Neurological Associates, Ltd.) Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for AbbVie. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly and Company. Dr. Klein has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lundbeck. Dr. Klein has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AbbVie. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Klein has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. The institution of Dr. Klein has received research support from AbbVie. Dr. Klein has received personal compensation in the range of $500-$4,999 for serving as a Shareholder with AppsbyDocs, LLC. Dr. Klein has a non-compensated relationship as a Chair, Practice Management Committee with American Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Laszlo Mechtler, MD, FEAN, FASN, FAHS, FÂ鶹´«Ã½Ó³»­ (Dent Neurologic Institute) Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel Pharma. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Mechtler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Hyperfine. Dr. Mechtler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Dr. Mechtler 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 Genomate Health. The institution of Dr. Mechtler has received research support from The Harry Dent Family Foundation, Inc. The institution of Dr. Mechtler has received research support from Alpheus medical. The institution of Dr. Mechtler has received research support from Shiratronics. The institution of Dr. Mechtler has received research support from Abbvie Inc. The institution of Dr. Mechtler has received research support from Amgen. The institution of Dr. Mechtler has received research support from Eli Lilly Company. The institution of Dr. Mechtler has received research support from H. Lundbeck HS. The institution of Dr. Mechtler has received research support from Pfizer. The institution of Dr. Mechtler has received research support from Hyperfine. Dr. Mechtler has received personal compensation in the range of $100,000-$499,999 for serving as a Ownership interest with Neurology Practce Consortium GPO. Dr. Mechtler has a non-compensated relationship as a Board member with International Headache Society that is relevant to Â鶹´«Ã½Ó³»­ interests or activities.
Brian M. Plato, DO Dr. Plato has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Plato 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. Dr. Plato has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Amgen. Dr. Plato has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan. Dr. Plato has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Plato has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven.
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.
No disclosure on file
Janette Contreras-De Lama Janette Contreras-De Lama has received personal compensation for serving as an employee of AbbVie. Janette Contreras-De Lama has stock in AbbVie.