SAN FRANCISCO—Migraine patients treated with the oral investigative agent ubrogepant — a calcitonin gene-related peptide (CGRP) receptor antagonist — achieved pain relief after two hours more frequently than those taking a placebo, researchers reported here at the annual meeting of the American Headache Society.
"In this trial, we've shown that patients who took ubrogepant had a one in five chance of being pain-free at two hours, and two-thirds of the patients had a chance of pain relief at two hours," David W. Dodick, MD, FAAN, professor of neurology and director of the headache program at the Mayo Clinic, Scottsdale, AZ, told the Neurology Today Conference Reporter.
About 19.2 percent of patients treated with the 50 mg dose of ubrogepant achieved migraine pain-free status within two hours compared with 11.8 percent of placebo patients (p=0.0017), and 21.2 percent of patients receiving the 100 mg dose of ubrogepant were pain-free at two hours (p<0.0001), Dr. Dodick reported in his oral presentation.
In the ACHIEVE 1 trial, patients treated with ubrogepant also achieved the co-primary endpoint of freedom from the most bothersome migraine symptom at two hours — photophobia. Dr. Dodick said that 27.8 percent of placebo patients achieved that milestone at two hours compared with 38.6 percent of the patients on the single dose of ubrogepant (p=0.0001) and 37.7 percent of patients on the 100 mg dose of ubrogepant (p=0.0001).
Dr. Dodick said that the agent was "well-tolerated with no safety concerns identified. The side effect profile was similar to that of placebo."
"This was an acute treatment trial," Dr. Dodick said. "Patients took the drug for a single attack. The trial was placebo controlled. More than 40 percent of the patients in this trial were able to return to normal function at two hours," he said, which is equivalent to what has been found with triptans.
But in commenting on the trial, session moderator Elizabeth Loder, MD, MPH, chief of the division of headache and pain at Brigham & Women's Hospital/Faulkner Neurology and professor of neurology at Harvard Medical School, questioned the comparison to triptans.
"We don't have head-to-head comparisons with triptans," she told the Neurology Today Conference Reporter. "These studies provide more information to the clinician. The drug certainly works better than placebo, but the results seem quite modest."
"I think pricing will determine how this is used," she added.
Dr. Dodick disclosed commercial relationships with the Academy for Continued Healthcare Learning, Acorda, Alder, Allergan, Amgen, Biohaven, Chameleon Communication, Charleston Laboratories, Electrocore, Eli Lilly, eNeura, Epien, Global Scientific Communications, Haymarket Medical Communication, Healint, Healthlogix, KingDevick Technologies, Medlogix, Medscape/WebMD, Meetinglogix, Miller Medical, Mobile Health Second Opinion, Nocira, Novartis, Peer View Institute, Promius, Superus, Teva, Theranica, Xenon, and Zosano. Dr. Loder disclosed no commercial relationships.
LINK UP RELATED INFORMATION:
Voss T, Lipton RB, Dodick DW, et al. A phase IIb randomized, double-blind, placebo-controlled trial of ubrogepant for the acute treatment of migraine. Cephalalgia 2016: 36(9):887-898.