AbbVie has reported primary data from the ECLIPSE Phase III study, assessing the tolerability, safety and efficacy of Aquipta (atogepant) 60mg compared to placebo for acute migraine treatment in adults, both with or without aura.
The double-blind, randomised, placebo-controlled, multiple-attack pivotal study achieved its main and key secondary endpoints.
Atogepant showed superiority in achieving pain freedom and freedom from the most bothersome migraine symptom (MBS) two hours after treatment following the first attack.
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In the trial, the initial 12 of the 16 key secondary goals also met statistical significance, including freedom from MBS at two hours following treatment.
The safety profile of the once-daily orally administered calcitonin gene-related peptide (CGRP) receptor antagonist over the 24-week period aligned with earlier studies of its use in migraine prevention, with no new safety signals observed.
The most common treatment-emergent adverse events during the double-blind period were upper respiratory tract infection (2.3%) and nasopharyngitis (4.6%).
ECLIPSE enrolled 1,223 subjects aged 18 to 75 years with a history of migraine, who experienced two to eight moderate or severe attacks per month before screening.
It was conducted at 149 sites in China, Europe, Japan, South Korea, Taiwan, and the UK. Participants were randomised to four double-blind treatment sequences for treating four qualifying attacks with single atogepant (60mg) doses or placebo.
AbbVie immunology, neuroscience, eye care and speciality development senior vice-president Primal Kaur said: “These latest ECLIPSE results mark a step forward in helping more people living with migraine achieve pain freedom and underscores our commitment to addressing unmet needs in acute migraine care.”
The company has submitted an application to the European Medicines Agency for atogepant’s expanded use for acute migraine treatment in adults across Europe.
In July 2025, AbbVie reported encouraging topline outcomes from the first of two replicate trials of the Phase III UP-AA programme, assessing Rinvoq (upadacitinib), at both 15mg and 30mg doses in adult and adolescent subjects with severe alopecia areata (AA) with a mean baseline SALT score of 83.8.
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