Allergan’s acute migraine therapy ubrogepant shows strength at Phase 3
pharmafile | November 20, 2019 | News story | Research and Development | Allergan, pharma, ubrogepant
Allergan has revealed positive Phase 3 data on its oral calcitonin gene-related peptide (CGRP) receptor antagonist ubrogepant, illustrating the therapy’s strength compared to placebo in the acute treatment of migraine.
The data revealed that both 25mg and 50mg doses of ubrogepant displayed “statistically significant higher response rates” for pain freedom at two hours compared to placebo, with rates standing at 21.8% and 20.7% versus 14.3%. The same was said for the 50mg dose in relation to the most bothersome migraine-associated symptom, with a 38.9% rate for ubrogepant compared to 27.4% with placebo at two hours.
Furthermore, the findings demonstrated that ubrogepant outclassed placebo in the absence of light or sound sensitivity, with response rates recorded at 43.8% and 54.1% compared to 35.5% and 46.3% respectively.
“Migraine is the second leading cause of disability, and we need new acute treatments that are efficacious, safe, and tolerable,” said Dr Richard B Lipton, Lead Author, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center. “Having ubrogepant as a potential new medication for the acute treatment of migraine will provide much-needed innovation for a disease that causes lost time for millions of people.”
Dr Mitchell Mathis, Vice President and Chief Medical Officer, Central Nervous System at Allergan, also commented: “If approved, ubrogepant will provide a new and different acute treatment option for patients suffering the debilitating pain and other symptoms of migraine. Allergan has a long history of developing migraine medications and remains committed to continued innovation of new treatments. Ubrogepant is a completely new approach to the acute treatment of migraine. This would expand Allergan’s migraine portfolio that includes Botox, the first FDA-approved, preventive treatment for adults with chronic migraine.
“We are also continuing to advance the Phase 3 clinical programme for atogepant, our second orally-administered gepant specifically for migraine prevention. We believe in having multiple treatment options available because we know not every patient will respond to every medication. We believe that patients should have open access to all new treatments for migraine.”
Matt Fellows
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