AbbVie set to present phase 3 ECLIPSE data highlighting atogepant superiority over placebo

AbbVie has officially announced primary results from the pivotal Phase 3 ECLIPSE study, evaluating the safety, efficacy and tolerability of atogepant versus placebo for the acute treatment of migraine in adults. The study met its primary and key secondary endpoints, with atogepant demonstrating superiority in pain freedom and freedom from most bothersome migraine symptom two hours after treatment of the first migraine attack.

“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,” said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. “With our submission to the European Medicines Agency, AbbVie remains dedicated to broadening treatment choices for patients. If approved, atogepant would offer a new acute treatment option for migraine attacks in Europe.”

“Migraine is a highly debilitating disease with a profound impact on daily life. Despite available therapies, many people still encounter barriers to effective, flexible treatment,” says Annelies Van Dycke, neurologist, ECLIPSE investigator, and head of neurology at AZ Sint-Jan, Bruges, Belgium. “Providing access to targeted treatments such as atogepant within integrated care plans has the potential to make a meaningful difference in the lives of patients with migraine.”

Note that the safety profile of atogepant over the 24-week treatment period was consistent with that observed in previous studies for the preventive treatment of migraine. No new safety signals were observed in the acute treatment of migraine as compared to the safety profile for the preventive treatment of migraine. In the double-blind period across 24 weeks, the most common treatment-emergent adverse events were nasopharyngitis and upper respiratory tract infection.

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Related Topics and Keywords

AbbVie, Atogepant (AQUIPTA®), migraine, Phase 3 ECLIPSE Data