Allergan’s ubrogepant doses smash primary endpoints in acute treatment of migraine

pharmafile | December 5, 2019 | News story | Research and Development Allergan, FDA, pharma, ubrogepant 

New Phase 3 data has been released showing that both 50mg and 100mg doses of Allergan’s ubrogepant met their primary endpoints in the acute treatment of migraine.

The therapy is looking to become the FDA’s first small molecule, oral calcitonin gene-related peptide (CGRP) receptor antagonist in this indication. The newly unveiled findings showed that ubrogepant demonstrated “statistically significant higher response rates” for freedom from pain two hours after initial treatment, coming in at 19.2% for the 50mg dose and 21.2% for the 100mg dose, compared to 11.8% with placebo.  

Furthermore, the drug generated freedom from the most bothersome migraine-associated symptoms – meaning patients experienced no sensitivity to light or sound as well as no nausea – after two hours in 38.6% of patients with 50mg and in 37.7% with 100mg, compared to 27.8% with placebo.  

In the trial’s secondary endpoint, both ubrogepant doses outclassed placebo in pain relief at two hours following treatment, with 60.7% of 50mg patients and 61.4% of 100mg patients reporting that their moderate or severe headaches were reduced to mild or no pain at all, compared to 49.1% with placebo.

“The findings from the ACHIEVE I trial are particularly meaningful for primary care physicians who are first-line in migraine management and need treatment options that are safe and effective to treat debilitating migraine symptoms,” said Dr Susan Hutchinson, Family Practice Headache Specialist and Founder of Orange County Migraine & Headache Center and paid consultant for Allergan. “With limited migraine-specific acute treatment options on the market, the approval of ubrogepant would provide healthcare providers and patients a much-needed new treatment option with a favourable side-effect profile that can be taken on-demand to effectively treat a migraine attack.”

Mitchell Mathis, Allergan’s Chief Medical Officer, Central Nervous System, also commented: “We are pleased to see the results from our pivotal Phase 3 trial published in The New England Journal of Medicine. With the ACHIEVE II trial results recently published in The Journal of the American Medical Association, the recognition from these two prestigious medical journals underscores the significance of ubrogepant as a promising oral option for the acute treatment of migraine. We are proud of the research and science that have brought us to this point and look forward to continuing innovation in the pursuit of migraine freedom.”

Matt Fellows

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