Safety and tolerability studies have been completed for ubrogepant (Allergan, Dublin, Ireland) in patients with acute migraine over 1 year (NCT2867709) and in healthy volunteers over 8 weeks (3110-105-002). Both were randomized placebo-controlled studies.
Ubrogepant was well tolerated, had no adverse events significantly different from placebo, and showed no signs of hepatic safety concerns. In phase 3 trials, ubrogepant was shown effective for acute treatment of migraine, increasing the percentage of patients who achieved pain relief within 2 hours and improving patients most bothersome symptoms compared to usual treatments.
In open-label extension of the ACHIEVE I (NCT02828020) and ACHIEVE II (NCT027709) studies, 1,230 patients were identified as the safety population who took ubrogepant or their usual medication (the control arm). Of that population, 76% completed 52 weeks of treatment, comprising 21,454 migraine attacks treated with 31,968 doses of 50 mg or 100 mg ubrogepant.
In study 3110-105-002, just over 500 healthy adults received 2 days of consecutive treatment with ubrogepant 100 mg, alternating with 2 days of placebo. This study design mimicked the episodic occurrence of migraine and how it is treated acutely. Neither study demonstrated significantly different adverse events compared to placebo nor hepatic safety issues.
Based on these safety and tolerability studies and previous efficacy studies, it is expected that a new drug application (NDA) will be submitted to the Food and Drug Administration by the first quarter of 2019. Ubrogepant will likely be the first NDA filed for an oral calcitonin gene-related peptide (CGRP) antagonist.
Dr. Richard B. Lipton, Vice Chair of Neurology, Professor of Epidemiology and Population Health and Director of the Montefiore Headache Center at the Albert Einstein College of Medicine stated, “Despite the prevalence of migraine, there remains a need for additional therapeutic options for patients, some of whom are not candidates for currently available treatments.”Next Story