The U.S Food and Drug Administration has now approved a new medication for migraines. The drug is called ‘ubrogepant (Ubrelvy)’ and comes in the form of a pill that treats the migraine on the spot instead of prevention.
"Migraine is an often disabling condition that affects an estimated 37 million people in the U.S.," said Dr. Billy Dunn, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. "Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication."
Approval for Ubrelvy came after two clinical studies involving more than 1,400 adults. The study was funded by the pharmaceutical company Allergan and findings were published in the Journal of the American Medical Association.
"In both studies, the percentages of patients achieving pain freedom two hours after treatment [defined as a reduction in headache severity from moderate or severe pain to no pain] and whose most bothersome migraine symptom (nausea, light sensitivity or sound sensitivity) stopped two hours after treatment, were significantly greater among patients receiving Ubrelvy at all doses compared to those receiving placebo," the FDA said.
Learn more about migraines:
Every drug comes with side-effects and in the two clinical trials nausea, fatigue, and dry mouth were commonly reported.
The drug is part of a new class of medications known as the CGRP inhibitors. During a migraine episode, CGRP is a protein that is released by the trigeminal nerve. “It's believed to play a key role in generating migraine misery”, explained Dr. Richard Lipton, who directs the Montefiore Headache Center at Albert Einstein Medical College in New York City.
As opposed to the three approved CGRP inhibitors that come in an injection format, ubrogepant is unique because it comes in a tablet. In the study, ubrogepant was found to beat the placebo treatment in reducing the pain and easing any other migraine symptoms including sensitivity to light and sound. The drug could become the standard treatment for migraines as opposed to the current drug, Triptan.
“They include people who do not get relief from current acute treatments, and those who cannot take the medications because of side effects or safety concerns,” Lipton said.
The current standard treatment, Triptan, works by stimulating the release of serotonin that reduces inflammation and constricts blood flow. However, that can make it worse for migraine suffers because constriction of blood vessels can increase the risk of a heart attack or a stroke. This why researchers are hopeful that ubrogepant will provide more treatment options for migraine sufferers.
“It will be "exciting" to have new options for patients who cannot take triptans,” said a neurologist who was not involved in the study.
"There haven't been any new acute treatments in a long time," Dr. Rachel Colman, of Mount Sinai's Icahn School of Medicine.