Allergan received approval from the U.S. FDA for UBRELVY (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start. Migraine is a neurological disease characterized by intermittent migraine attacks with symptoms that are often incapacitating. Migraine afflicts 31 million Americans and is the third most common disease and second leading cause of disability worldwide.
 
The approval is based on clinical trials demonstrating quick pain relief for the majority of migraine patients. UBRELVY also met co-primary endpoints of freedom from pain and freedom from the most bothersome symptom (nausea, hypersensitivity to light, or hypersensitivity to sound), a recent, more stringent standard of efficacy the FDA set in 2018. UBRELVY provided lasting relief up to 24 hours.
 
UBRELVY works in a new way by blocking CGRP, a protein that is released during a migraine attack, from binding to its receptors. It works without constricting blood vessels, which some older treatments are known to do. UBRELVY is non-narcotic, not scheduled, and does not have addiction potential.
 
“We are extremely pleased that UBRELVY is now approved by the FDA. As the first oral gepant, UBRELVY offers a new and different type of acute treatment option for people living with the debilitating pain and other symptoms of migraine,” said David Nicholson, executive vice president and chief R&D officer, Allergan. “Its oral administration with two dose strengths allows for treatment flexibility and relief when a migraine attack occurs. As we continue to drive innovation in migraine treatment, we are very proud to offer patients another option, and we are confident that it will make a difference for those in need. At Allergan, we believe that migraine patients deserve access to all new medications for this debilitating disease.”