London, Aug 2 Atogepant, a prescription medicine, is safe and effective to treat chronic migraine, which affects more than one billion individuals each year across the world, according to new trial results published in The Lancet.
Migraine is defined as "an episodic headache associated with certain features, such as sensitivity to light, sound, or movement" or "a recurring syndrome of headache associated with other symptoms of neurologic dysfunction in varying admixtures".
It is the second leading cause of disability globally, and is one of the most common neurologic disorders, with a high prevalence and morbidity, especially among young adults and females
The new study, led by an international team of researchers, evaluated the efficacy, safety, and tolerability of atogepant, developed by US drug major AbbVie and marketed as Qulipta, for the preventive treatment of chronic migraine.
The randomised, double-blind, placebo-controlled, phase 3 trial included 778 participants from the US, the UK, Canada, China, Czech Republic, Denmark, France, Germany, Italy, Japan, South Korea, Poland, Russia, Spain, Sweden, and Taiwan.
The participants were adults aged 18-80 years with a 1-year or longer history of chronic migraine who were randomly assigned to receive oral atogepant 30 mg twice a day, oral atogepant 60 mg once a day, or placebo.
"Atogepant 30 mg twice a day and 60 mg once a day showed clinically relevant reductions in MMDs across 12 weeks in chronic migraine patients. Both atogepant doses were well tolerated, consistent with the known safety profile of atogepant," said correspondence author Patricia Pozo-Rosich, from the Universitat Autonoma of Barcelona in Spain.
Most common adverse events for atogepant were constipation and nausea.
Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist specifically developed for the preventive treatment of migraine in adults who have four or more migraine days per month.
Studies have shown that the concentration of CGRP protein in the brain increases during migraine attacks or episodes of headaches, initiating migraines, and worsen the pain or prolong the attack.
Atogepant binds to the CGRP receptor on the brain’s trigeminal nerve and blocks the activation of the migraine.
Atogepant has been approved by the USFDA, Health Canada for the preventive treatment of episodic migraine in adults, and a positive opinion from the European Medicines Agency.
Besides Qulipta (atogepant), AbbVie also offers Botox (onabotulinumtoxinA) -- preventive treatment for patients with chronic migraine; and Ubrelvy (ubrogepant) -- an acute treatment for adults with migraine.
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