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P.020 Long-term safety and tolerability of atogepant 60mg once daily for preventive treatment of migraine: a phase 3, 40-week, multicenter extension to the advance trial

Published online by Cambridge University Press:  24 June 2022

B Klein
Affiliation:
(Abington)
R Miceli
Affiliation:
(Madison)
L Severt
Affiliation:
(Madison)
P McAllister
Affiliation:
(Stamford)
L Mechtler
Affiliation:
(Amherst)
J McVige
Affiliation:
(Amherst)
M Diamond
Affiliation:
(Chicago)
MJ Marmura
Affiliation:
(Philadelphia)
E Leroux
Affiliation:
(Montreal)*
H Guo
Affiliation:
(Madison)
M Finnegan
Affiliation:
(Madison)
J Trugman
Affiliation:
(Madison)
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Abstract

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Background: A phase 3 trial, ADVANCE (NCT03777059), demonstrated that atogepant, an oral, CGRP receptor antagonist dosed once daily, results in clinically meaningful reductions in mean monthly migraine days. This open-label extension for ADVANCE trial completers evaluated long-term safety and tolerability of atogepant over 40-weeks. Methods: Participants in this trial (NCT03939312), rolled over from the ADVANCE trial, were treated with atogepant 60mg once daily for 40-weeks, with a 4-week safety follow-up. Only safety data were collected. Results: 685 participants took at least one dose of study drug, 74.6% completed the 40-week treatment period; mean age of 41.8 years, 88.2% female, 84.4% white, and mean BMI of 30.58 kg/m2. Mean (SD) treatment duration was 233.6 (89.32) days. 62.5% of participants experienced a treatment-emergent adverse event (TEAE), with 8.8% considered treatment-related by the investigator; serious adverse events (SAEs) occurred in 3.4% of participants, none were treatment-related. The most frequent AEs leading to discontinuation was nausea (0.4%, n=3); the most frequent TEAEs observed included upper respiratory tract infection (5.5%, n=38) and urinary tract infection (5.3%, n=36). No deaths or hepatic safety issues were observed. Conclusions: Safety results are consistent with known safety profile of atogepant and support long-term safety and tolerability of once daily dosing of atogepant 60mg.

Type
Poster Presentations
Copyright
© The Author(s), 2022. Published by Cambridge University Press on behalf of Canadian Neurological Sciences Federation