Allergan’s oral CGRP antagonist showed a higher likelihood of freedom from pain and associated symptoms during mild headaches for patients with migraine compared to attacks of moderate to severe severity.
Richard B. Lipton, MD
Data which were scheduled to be presented at the American Academy of Neurology (AAN) 2020 Annual Meeting suggest that patients with migraine who are treated with ubrogepant (Ubrelvy; Allergan) during mild headaches have an increased likelihood of becoming free of pain and associated symptoms.1
The phase 3 open-label, 52-week extension trial (NCT02873221) randomized adults with migraine in 1:1:1 fashion to usual care, 50-mg ubrogepant, or 100-mg ubrogepant, and treated ≤8 migraine attacks of any pain severity every 4 weeks. The data showed that 39% of those in the 50-mg group and 43% of those in the 100-mg group achieved pain freedom in attacks of mild pain, compared to 19% and 21%, respectively, in those groups when treating attacks of moderate to severe pain (P <.0001 for both).
“Ubrogepant demonstrated efficacy in treating migraine with moderate/severe pain in 2 phase-3 trials. Clinical guidance recommends treatment of migraine when pain is mild, a strategy not previously studied for ubrogepant,” the study authors, including Richard B. Lipton, MD, director, Montefiore Headache Center, and professor of neurology, Albert Einstein College of Medicine.
This assessment included 808 patients with a mean age of 42 years, with analysis incorporating 21,454 treated migraine attacks. First treated attack data trended similarly for both groups.
The absence of photophobia was achieved in a mean of 55% for both doses for attacks treated with mild pain compared to 34% for both doses for moderate/severe pain (P <.0001 for both). Likewise, the absence of phonophobia was reported in an average of 64% and 70% of attacks treated with mild pain in the 70-mg and 140-mg groups, respectively, compared to 42% and 45% of attacks of moderate to severe pain (P <.0001 for both).
On average, 83% and 82% of the low- and high-dose groups reported an absence of nausea in attacks of mild pain compared to 67% and 68% in attacks of moderate-to-severe pain, respectively (P <.0001). Overall, 10% of study participants reported treatment-related adverse events (AEs), though only 1 was considered serious (exacerbation of sinus tachycardia).
Earlier this year, data from a long-term extension study of ubrogepant used intermittently for the acute treatment of migraine is both safe and tolerable for patients, with little incidence of treatment-related AEs or need to discontinue medication accompanying its use. The 52-week, phase 3 data included 1230 participants receiving either 50-mg (n = 404) or 100-mg (n = 409) ubrogepant who administered 1 to 2 doses per migraine attack, or usual care (n = 417). All told, treatment-related AEs were reported by 10% (n = 42) and 11% (n = 43) of the low and high dose groups. Only 2% (n = 9) and 3% (n = 12) of those in the 50- and 100-mg groups, respectively, experienced serious AES. Discontinuation due to AEs occurred in 2.2% (n = 9) and 2.7% (n = 11) of the treatment groups.2
Ubrogepant was approved by the FDA for the acute treatment of migraine with or without aura in adults, making it the first-in-class oral calcitonin gene-related peptide (CGRP) antagonist for this indication, in December 2019. Its new drug application was supported by data from the 2 pivotal studies—ACHIEVE I and II—as well as 2 additional safety studies. The results showed that both doses were effective, with patients reporting significant rates of pain freedom and freedom from most bothersome symptoms at 2 hours post-dose. It is contraindicated for co-administration with strong CYP3A4 inhibitors.3
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1. Lipton R, Dodick D, Goadsby PJ, et al. Ubrogepant is Effective in the Acute Treatment of Migraine with Mild Pain. Neurology. 2020;94(15 Suppl): 4726.
2. Ailani J, Lipton RB, Hutchinson S, et al. Long‐Term Safety Evaluation of Ubrogepant for the Acute Treatment of Migraine: Phase 3, Randomized, 52‐Week Extension Trial. Headache. Published online January 8, 2020. doi: 10.1111/head.13682.
3. FDA approves new treatment for adults with migraine [press release]. Silver Springs, MD: FDA; Published December 23, 2019. Accessed April 28, 2020. fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine.