Allergan’s atogepant fulfils primary endpoint in episodic migraine

pharmafile | June 12, 2018 | News story | Manufacturing and Production, Research and Development Allergan, atogepant, migraine, pharma 

Allergan has made ground in its quest to become “the headache company” with the release of new Phase 2b/3 data for its oral calcitonin gene-related peptide (CGRP) receptor antagonist atogepant, showing that the therapy met its primary endpoints for episodic migraine across all treatment arms and five different dosing regimens.

Across the 795 trial participants, atogepant demonstrated a “statistically significant” reduction from baseline in monthly migraine/probable migraine (MPM) headache days compared to placebo after 12 weeks of treatment. The drug’s safety profile was found to be in line with the effects shown by the placebo.

“These exciting results demonstrate the potential for atogepant for a broad spectrum of migraine patients. The efficacy and safety across doses and dose regimens show promise in a patient population with high unmet treatment needs,” said Dr. Peter Goadsby, Neurologist and Professor at Kings College, London and University of California, San Francisco. “Results from this atogepant trial provide continued evidence for the clinical potential of oral CGRP antagonists and the substantial value of progressing research and developing new treatments for migraine patients.”

Allergan Chief Commercial Officer Bill Meury added: “The positive results from this study show that oral atogepant has a compelling profile relative to other treatment options on the market and in development for the prevention of migraine. We are excited about the prospects for this product and rapidly moving to the next stage of development. Allergan has one of the most innovative and deepest product lines for migraine in the industry, with Botox approved for the prevention of chronic migraine and oral atogepant and ubrogepant in development for the prevention and acute treatment of migraine.”

The company confirmed it will now speak to regulatory authorities around the world before pursuing further Phase 3 trials.

Matt Fellows

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