Canadian Migraine Victims Have New Therapy Possibility

– UBRELVY^® is the primary and solely oral CGRP receptor antagonist (gepant) accredited by Well being Canada for the acute therapy of migraine

— UBRELVY^® was demonstrated to scale back or eradicate migraine ache with a single oral pill, with the flexibleness to take an elective second dose for persistent ache

MONTREAL, Nov. 16, 2022 /CNW/ – AbbVie (NYSE: ABBV) introduced at present that Well being Canada has accredited UBRELVY^® (ubrogepant pill) for the acute therapy of migraine, with or with out aura, in adults.¹ UBRELVY^® is the primary orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the therapy of migraine assaults as soon as they begin.

An estimated 2.7 million Canadians have been recognized with migraine, which is estimated to underrepresent at present’s migraine prevalence.² Migraine is a posh neurological illness with recurrent assaults that lasts 4-72 hours. It may be outlined by signs equivalent to reasonable to extreme ache depth, nausea, vomiting, photophobia and phonophobia.³ It is among the main causes of incapacity on the earth.⁴

“I see first-hand the unimaginable impression migraines can have on my sufferers. Whenever you endure an assault, some sufferers are pressured to hunt solitude and take away themselves from every thing of their lives. It may be insufferable and impression one’s interplay with household, buddies, faculty and work,” mentioned Dr. Jonathan Gladstone, MD, FRCPC, neurologist and Director of the Gladstone Headache Clinic in Toronto. “Well being Canada’s approval of UBRELVY is a vital step ahead permitting physicians to offer a brand new migraine-specific choice for migraine victims. The gepant class is among the most evaluated focused therapies for migraine therapy. I am excited to have one other therapy choice obtainable to assist sufferers efficiently handle their migraines.”  

Calcitonin gene-related peptide (CGRP) is a neuropeptide current within the peripheral and central nervous system. CGRP is launched from sensory nerve endings throughout a migraine assault, notably the nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, excessive affinity (Ok_i = 0.07nM) CGRP receptor antagonist (gepant) that blocks the binding of CGRP to its receptor and antagonizes CGRP receptor perform. UBRELVY® was demonstrated to scale back or eradicate migraine ache with a single oral pill, with the flexibleness to take an elective second dose for persistent ache.¹

“Migraine can usually be a debilitating illness that may impression an individual’s potential to perform and carry out their each day routines. With the ability to efficiently handle migraine assaults as they happen is crucial,” says Wendy Gerhart, Govt Director, Migraine Canada. “Migraine Canada welcomes the approval of UBRELVY^® in Canada as a brand new and revolutionary therapy choice. This may have a optimistic impression for the migraine neighborhood throughout the nation.”

The efficacy of UBRELVY^® for the acute therapy of migraine was demonstrated in two multicenter, randomized, double-blind, placebo-controlled, single migraine assault research. These research enrolled sufferers with a historical past of migraine with and with out aura, based on the ICHD-3 beta diagnostic standards, and who skilled 2 to eight migraine assaults per 30 days with reasonable to extreme headache ache.  In Examine 1 (ACHIEVE I), sufferers have been randomized to obtain UBRELVY 50 mg or 100 mg or placebo; and in Examine 2 (ACHIEVE II), sufferers have been randomized to obtain UBRELVY 50 mg or placebo. Sufferers have been permitted to make use of customary migraine preventive medicines through the examine. At baseline, 23% p.c of sufferers have been taking preventive medicines for migraine. Probably the most generally used preventive medicines have been topiramate, onabotulinumtoxinA, propranolol, and amitriptyline.¹

“UBRELVY^® as the primary oral gepant accredited in Canada for the acute therapy of migraine is a vital milestone in our dedication to deliver revolutionary new medicines to Canadians with the aim make a significant distinction for sufferers,” says Tracey Ramsay, Vice President and Common Supervisor, AbbVie Canada.

About UBRELVY^® (ubrogepant pill) ¹
UBRELVY^® (ubrogepant pill) is indicated for the acute therapy of migraine, with or with out aura, in adults.

Calcitonin gene-related peptide (CGRP) is a neuropeptide current within the peripheral and central nervous system. CGRP is launched from sensory nerve endings throughout a migraine assault, notably the nerve endings of sensory trigeminal ganglion neurons. Ubrogepant is a small molecule, excessive affinity (Ok_i = 0.07nM) CGRP receptor antagonist (gepant) that blocks the binding of CGRP to its receptor and antagonizes CGRP receptor perform. UBRELVY^® was demonstrated to scale back or eradicate migraine ache with a single oral pill, with the flexibleness to take an elective second dose for persistent ache.

UBRELVY^® is contraindicated:

• In sufferers with hypersensitivity to this drug or to any ingredient within the formulation, together with any non-medicinal ingredient, or part of the container
• With concomitant use of sturdy CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)

Please seek the advice of the UBRELVY^® Product Monograph here.

About AbbVie

AbbVie’s mission is to find and ship revolutionary medicines that remedy critical well being points at present and handle the medical challenges of tomorrow. We try to have a exceptional impression on folks’s lives throughout a number of key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, ladies’s well being and gastroenterology, along with services and products throughout its Allergan Aesthetics portfolio. For extra details about AbbVie, please go to us at www.abbvie.ca. Comply with AbbVie Canada on Twitter, on Instagram or discover us on LinkedIn.

SOURCE AbbVie Canada

For additional info: Media Inquiries: Dominique Touchette, AbbVie Canada, 438-821-3971, [email protected]