Montefiore Helps Lead Investigational Migraine Study Evidencing Promising Results

Teva’s Fremanezumab Demonstrates Early Onset of Efficacy for the Preventive Treatment of Chronic Migraine

New York’s Montefiore Headache Center helped conduct a large-scale clinical trial testing Allergan’s ubrogepant with migraine headache patients. The new drug shows promise.

Migraine: A Massive Problem

Up to 40 million Americans and one billion worldwide suffer form migraines. Fox 6 Now reports one in five women and one in 16 men are afflicted according to the American Migraine Foundation. Anyone who has ever experienced the onslaught of an intense migraine headache can appreciate if a more effective treatment may be on the market soon. 

What is Ubogepant?

Ubrogepant is an investigational drug for the treatment of migraine. It is a small-molecule calcitonin gene-related peptide receptor antagonist. Produced by Allergan, the drug may relieve pain of acute migraine attacks as well as other bothersome migraine-related symptoms. Thus far, the drug is well tolerated and doesn’t evidence any material safety concerns.  The FDA accepted Allergan’s NDA submission for the treatment in March of this year.

The new drug targets a protein called calcitonin gene-related peptide (CGRP) which is involved in the transmission of pain. As it turns out, as migraines flare the levels of CGRP flare and by blocking the pain the Allergan’s investigational drug stops pain and hence heads off the migraine. Of note, blood vessels are precluded and hence the drug, if approved, could be an option for those at risk of heart attack.

Competition with Triptans

Not all are sold on the superiority of ubrogepant. According to Stephen Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University, triptans have evidenced response rates ranging from 40% to 75% according to reviews by independent drug analyst the Institute for Clinical and Economic Review. Hence, Dr. Siberstein notes, “The study clearly shows the drug is effective” and he believes it may be “an option for patients who can’t tolerate triptans.” 

The Study

In the latest study, ubrogepant evidenced greater rates of pain and symptom relief from migraine compared to a placebo—over 20% of study participants given the drug reported to be pain-free within two hours and over 34% relieved of the most bothersome symptoms associated with migraine including sensitivity to light and noise for example. The placebo compared 14% and 27% respectively.

Clinical Investigator Comment

Dr. Richard B. Lipton, director of the Montefiore Headache Center, led the study that was published November 19, 2019 in the medical journal JAMA. Lipton reported, “Having ubrogepant as a potential new medicine for the acute treatment of migraine will provide much-needed innovation for a disease that causes lost time for millions of people.” He noted that migraine actually represents the second leading cause of disability. Dr. Lipton is also a consultant for Allergan as well.

Call to Action: Do you struggle with migraines and your current medications don’t work well? Perhaps this new drug ubrogepant will be the answer. Allergan has filed a new drug application. TrialSite News will monitor the situation.