– UBRELVY® is the first and only oral CGRP receptor antagonist (gepant) approved by Health Canada for the acute treatment of migraine
— UBRELVY® shown to reduce or eliminate migraine pain with a single oral tablet, with the option of taking an optional second dose for persistent pain
MONTREAL, November 16, 2022 /CNW/ – AbbVie (NYSE: ABBV) today announced that Health Canada has approved UBRELVY® (ubrogepant tablet) for the acute treatment of migraine, with or without aura, in adults.1 UBRELVY® is the first orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they have started.
An estimated 2.7 million Canadians have been diagnosed with migraine, which underrepresents the current prevalence of migraine.2 Migraine is a complex neurological disease with recurrent attacks that last from 4 to 72 hours. It can be defined by symptoms such as moderate to severe pain intensity, nausea, vomiting, photophobia and phonophobia.3 It is one of the leading causes of disability worldwide.4
“I see firsthand the incredible impact migraines can have on my patients. When you are having an attack, some patients are forced to seek solitude and get away from everything in their lives. It can be unbearable and can have an impact on interaction with family, friends, school and work,” said Dr. Jonathan GladstoneMD, FRCPC, neurologist and director of the Gladstone Headache Clinic in Toronto. “Health from Canada The approval of UBRELVY is an important step forward allowing physicians to provide a new migraine-specific option for migraine sufferers. The gepant class is one of the most evaluated targeted therapies for the treatment of migraine. I am thrilled to have another treatment option available to help patients successfully manage their migraines.”
Calcitonin gene-related peptide (CGRP) is a neuropeptide found in the peripheral and central nervous system. CGRP is released from sensory nerve endings during a migraine attack, specifically the nerve endings of sensory neurons in the trigeminal ganglion. Ubrogepant is a small molecule, high affinity (KI = 0.07 nM) CGRP receptor antagonist (gepant) which blocks the binding of CGRP to its receptor and antagonizes the function of the CGRP receptor. UBRELVY® has been shown to reduce or eliminate migraine pain with just one oral tablet, with the option of taking an optional second dose for persistent pain.1
“Migraine can often be a debilitating condition that can impact a person’s ability to function and carry out daily routines. Being able to successfully manage migraine attacks as they arise is essential. occur,” says Wendy Gerhart, Executive Director, Migraine Canada. “Migraine Canada welcomes UBRELVY approval® in Canada as a new and innovative treatment option. This will have a positive impact on the migraine community across the country. »
The effectiveness of UBRELVY® for the acute treatment of migraine has been demonstrated in two multicenter, randomized, double-blind, placebo-controlled studies of a single migraine attack. These studies included patients with a history of migraine with and without aura, according to the ICHD-3 beta diagnostic criteria, who experienced 2 to 8 migraine attacks per month with moderate to severe headache. In Study 1 (ACHIEVE I), patients were randomized to receive UBRELVY 50 mg or 100 mg or placebo; and in Study 2 (ACHIEVE II), patients were randomized to receive UBRELVY 50 mg or placebo. Patients were allowed to use standard migraine preventative medications during the study. At baseline, 23% of patients were taking migraine preventative medication. The most commonly used preventive medications were topiramate, onabotulinumtoxinA, propranolol, and amitriptyline.1
“UBRELVY® as the first oral gepant approved in Canada for the acute treatment of migraine is an important step in our commitment to bringing innovative new medicines to Canadians with the goal of making a meaningful difference for patients,” said Tracey RamsayVice President and General Manager, AbbVie Canada.
About UBRELVY® (ubrogepant tablet) 1
UBRELVY® (ubrogepant tablet) is indicated for the acute treatment of migraine, with or without aura, in adults.
Calcitonin gene-related peptide (CGRP) is a neuropeptide found in the peripheral and central nervous system. CGRP is released from sensory nerve endings during a migraine attack, specifically the nerve endings of sensory neurons in the trigeminal ganglion. Ubrogepant is a small molecule, high affinity (KI = 0.07 nM) CGRP receptor antagonist (gepant) which blocks the binding of CGRP to its receptor and antagonizes the function of the CGRP receptor. UBRELVY® It has been shown to reduce or eliminate migraine pain with just one oral tablet, with the option of taking an optional second dose if pain persists.
UBRELVY® is contraindicated:
In patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container
With concurrent use of potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin)
Please consult the UBRELVY® Product monograph here.
AbbVie’s mission is to discover and deliver innovative medicines that solve the serious health problems of today and meet the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives in several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition products and services from its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitteron Instagram or find us on LinkedIn.
2 Ramage-Morin P., & Gilmour, H. (2014). Prevalence of migraine in the Canadian household population. Health Reports, 25(6): 10-16. https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-eng.pdf?st=CSyp19VF. Accessed November 2022.
3 Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache, 3rd Edition. Headache. 2018;38(1):1-211.
4 Steiner, TJ, Stovner, LJ, Jensen, R. et al. Migraine remains the second leading cause of disability worldwide and the first among young women: results from GBD2019. J Headache Pain 21, 137 (2020). https://doi.org/10.1186/s10194-020-01208-0
SOURCE AbbVie Canada
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