Migraine is a disabling neurological disorder characterised by a unilateral pulsating or throbbing pain that is moderate to severe. There are four stages of migraine: prodrome, aura, attack and postdrome. The prodrome stage of a migraine occurs between one to six hours before the onset of an attack and symptoms can include sensitivity to light and sound, fatigue and neck stiffness and/or pain. However, not all migraine patients experience prodromal symptoms, and the migraine stages may vary in terms of duration and severity between patients.
In Phase III, double-blind, placebo-controlled trial published in The Lancet, PRODROME (NCT04492020), patients with migraine who could identify prodromal symptoms that led to headache at least 75% of the time were randomly assigned to double-blind crossover treatment. The PRODROME study showed that there was an absence of headaches of moderate or severe intensity within 24 hours in 46% of prodrome events treated with 100mg of Ubrelvy versus 29% of prodrome events treated with placebo. Furthermore, there was an absence of headaches of any severity within 24 hours in 24% of prodrome events treated with Ubrelvy versus 14% of prodrome events treated with placebo. In addition, more patients had normal function within 24 hours of treatment with Ubrelvy during the prodrome stage versus placebo.
The migraine market is heavily genericised with many acute treatments for migraine pain relief, creating a competitive environment. Ubrelvy launched in the US in 2019 and was the first calcitonin gene-related peptide (CGRP) antagonist, or gepant, to enter the market for acute migraine treatment. Key opinion leaders (KOLs) previously interviewed by GlobalData believed that while triptans are the industry gold standard and are likely to remain the first-line treatment choice for migraine pain relief, Ubrelvy is an option for patients who cannot tolerate triptans.
KOLs also considered Eli Lilly’s Reyvow (lasmiditan), which launched in 2020, to be an alternative to triptan treatment. Unlike Pfizer’s gepant, Nurtec (rimegepant), which is approved as an acute treatment and as a preventive treatment for patients with up to 14 migraines per month, Ubrelvy has not been investigated for preventive properties to reduce the number of monthly migraine days. But Ubrelvy could provide additional benefit to migraine patients who are able to identify prodromal symptoms, with the ability to treat a migraine attack during its early stages. This could help differentiate Ubrelvy in a crowded migraine market. According to GlobalData’s clinical trial database, there are currently no ongoing or planned trials that investigate interventional products during the prodrome stage of migraine.
AbbVie is a strong player in the migraine market with an arsenal of treatments for the various stages of migraine. This includes Qulipta (atogepant) and Botox (onabotulinumtoxin A) as preventive treatments, and Ubrelvy for acute treatment.
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