Ubrogepant, approved for the acute treatment of migraine, demonstrated efficacy in treating migraine with moderate/severe pain. Clinical guidance recommends treatment when pain is mild, a strategy studied here for ubrogepant.
Design and setting:
Phase-3, open-label, 52-week trial (NCT02873221). Participants were randomized 1:1:1 to usual care or in blinded fashion to ubrogepant 50mg or ubrogepant 100mg, and treated up to 8 migraine attacks every 4 weeks.
Adults with migraine.
Main outcome measures:
Efficacy measures, collected only for ubrogepant groups, included 2-hour pain freedom and absence of migraine-associated symptoms.
Participants’ (n=808) mean age was 42 years; most were white and female. A total of 21,454 attacks were treated during the trial. Pain-free rates were higher for the treatment of mild vs moderate/severe pain (average percentage across all treated attacks): 39% vs 19% ubrogepant 50mg (P<0.0001) and 43% vs 21% ubrogepant 100mg (P<0.0001). Absence of photophobia was achieved in a higher proportion of attacks treated with mild pain vs moderate/severe pain: 55% both doses vs 34% both doses (P<0.0001). Absence of phonophobia was achieved in a higher proportion of attacks treated with mild pain vs moderate/severe pain: 64% vs 42% ubrogepant 50mg (P<0.0001) and 70% vs 45% ubrogepant 100mg (P<0.0001). Absence of nausea was achieved in a higher proportion of attacks treated with mild pain vs moderate/severe pain: 83% vs 67% ubrogepant 50mg (P<0.0001) and 82% vs 68% ubrogepant 100mg (P<0.0001). Overall, 10% of participants reported treatment-related adverse events; one was considered serious (exacerbation of sinus tachycardia).
Treating migraine patients with ubrogepant when headaches are mild rather than moderate/severe increases the likelihood of rendering them free of pain and associated symptoms.
Allergan (prior to its acquisition by AbbVie)
Richard B. Lipton, MD, serves on the editorial boards of Neurology and Cephalalgia and is a senior advisor for Headache. He has received research support from the National Institutes of Health. He also receives support from the Migraine Research Foundation and the National Headache Foundation. He has reviewed for the National Institute on Aging and National Institute of Neurological Disorders and Stroke; serves as consultant, advisory board member, or has received honoraria or research support from AbbVie, Amgen, Biohaven, Dr. Reddy’s Laboratories, electroCore, Eli Lilly, eNeuraTherapeutics, GlaxoSmithKline, Merck, Novartis, Teva, Vector, and Vedanta Research. He receives royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009), and Informa. He holds stock options in Biohaven.
David W. Dodick, MD, reports the following conflicts: Personal fees: AEON, Alder BioPharmaceuticals, AbbVie, Amgen, Amzak Health, Association of Translational Medicine, Autonomic Technologies, Axsome, Biohaven, Charleston Laboratories, Clexio, Daniel Edelman Inc., Dr Reddy’s Laboratories/Promius, electroCore LLC, Eli Lilly, eNeura, Equinox, Foresite Capital, Impel, Ipsen, Neurolief, Nocira, Novartis, Oppenheimer, Pieris, PSL Group Services, Revance, Salvia, Satsuma, Sun Pharma (India), Supernus, Teva, Theranica, University Health Network, Upjohn (Division of Pfizer), Vedanta, WL Gore, XoC, Zosano, and ZP Opco; Speaking fees: Amgen, Eli Lilly, Lundbeck, and Novartis Canada; Speakers bureaus: None; CME fees or royalty payments: Academy for Continued Healthcare Learning, Cambridge University Press, Catamount, Chameleon, Global Access Meetings, Global Life Sciences, Global Scientific Communications, Haymarket, HealthLogix, Medicom Worldwide, MedLogix Communications, Mednet, Miller Medical, Oxford University Press, PeerView, Universal Meeting Management, UpToDate (Elsevier), WebMD Health/Medscape, and Wolters Kluwer Health; Stock options: Aural Analytics, Epien, Healint, King-Devick Technologies, Matterhorn, Nocira, Ontologics, Precon Health, Second Opinion/Mobile Health, and Theranica; Consulting without fee: Aural Analytics, Epien, Healint, Second Opinion/Mobile Health; Board of Directors: Epien, King-Devick Technologies, Matterhorn, Ontologics, and Precon Health; Patent: 17189376.1-1466:vTitle: Botulinum Toxin Dosage Regimen for Chronic Migraine Prophylaxis without fee; Research funding: American Migraine Foundation, Henry Jackson Foundation, PCORI, and US Department of Defense; Professional society fees or reimbursement for travel: American Academy of Neurology, American Brain Foundation, American Headache Society, American Migraine Foundation, Canadian Headache Society, and International Headache Society.
Peter J. Goadsby, MD, PhD, DSc, reports personal fees from AbbVie and related grants and personal fees from Amgen and Eli Lilly and Company; personal fees from Alder Biopharmaceuticals, Autonomic Technologies Inc., Dr. Reddy’s Laboratories, electroCore LLC, eNeura, Novartis, Scion, Teva Pharmaceuticals, and Trigemina Inc.; personal fees from MedicoLegal work, Massachusetts Medical Society, Up-to-Date, Oxford University Press, and Wolters Kluwer; and a patent Magnetic stimulation for headache assigned to eNeura without fee.
Peter J. Goadsby, MD, PhD, DSc, Rami Burstein, PhD, has received research funds from AbbVie and is also a consultant for AbbVie.
Peter J. Goadsby, MD, PhD, DSc, Aubrey Manack Adams, PhD, Hongxin Lai, PhD, Sung Yun Yu, BA, Michelle Finnegan, MPH, and Joel M. Trugman, MD, are employees of AbbVie and may hold AbbVie stock.