Ubrogepant shows promise against migraine pain
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A higher percentage of patients with migraine who received ubrogepant — an experimental treatment — experienced freedom from their pain and the elimination of their most bothersome symptom 2 hours after they received the dose vs. patients who received placebo, according to results of a randomized trial published in The New England Journal of Medicine.
The drug, which is being developed by Allergan, is an oral, small-molecule calcitonin gene-related peptide receptor antagonist.
David W. Dodick, MD, a neurologist at the Mayo Clinic in Phoenix, and colleagues randomly assigned 1,436 patients (mean age, 40.5 years; 88.2% women) in an approximate 1:1:1 ratio to receive 50 mg of ubrogepant, 100 mg of ubrogepant or placebo. Patients had the option to take a second dose.
Dodick and colleagues found that 19.2% of patients in the 50 mg ubrogepant group, 21.2% in the 100 mg ubrogepant group and 11.8% in the placebo group had freedom from pain after 2 hours. In addition, 38.6% of patients in the 50 mg ubrogepant group, 37.7% of patients in the 100 mg ubrogepant group and 27.8% of patients in the placebo group had their most bothersome symptom relieved at 2 hours.
Researchers also reported that the most common adverse events — nausea, somnolence and dry mouth — occurred more frequently in the 100 mg ubrogepant group. These events began or worsened within 48 hours after the initial dose or the optional second dose of ubrogepant. Serious adverse events reported after 48 hours but before 30 days after dosing in the ubrogepant groups included appendicitis, pericardial effusion, seizure and spontaneous abortion, according to researchers.
“Trials evaluating consistency of effect, longer-term safety data and comparative effectiveness are needed to assess the safety and clinical utility of ubrogepant for acute migraine treatment,” Dodick and colleagues concluded. – by Janel Miller
Disclosures: Dodick reports numerous ties to industry. Please see the study for all authors’ relevant financial disclosures.