The 50-mg dose showed that 19.2% of patients were free of pain after 2 hours while the 100-mg dose resulted in 21.2% of pain-free patients.
Richard B. Lipton, MD
The first of a duo of phase 3 trials studying the efficacy and safety of oral ubrogepant (Allergan) for the treatment of single migraine attacks has reported positive results.
Led by Richard B. Lipton, MD, the vice chair of neurology, a professor of epidemiology and population health, and the director of the Montefiore Headache Center, at the Albert Einstein College of Medicine, the study showed that ubrogepant, in both doses examined, had a more significant reduction of pain and migraine-associated symptoms within 2 hours of the initial dose than placebo.
"Despite the prevalence of migraine and availability of several treatment options, the disease remains underdiagnosed and undertreated. There is also low persistence and adherence to the current standard of care treatments," Lipton said in a statement. "There remains a need for new treatments with improved benefit-risk profiles. Results from this ubrogepant phase 3 trial are important in progressing the research and developing therapies to help migraine patients."
The trial, ACHIEVE I, is testing 2 doses—50 mg (n = 423) and 100 mg (n =448)—of the calcitonin gene-related peptide (CGRP) receptor antagonist compared with placebo (n = 456). It involves 1327 adult patients, who had been treated for single migraine attacks of either moderate or severe intensity, 1:1:1 to the 3 arms.
The 50-mg dose showed that 19.2% of patients were pain free after 2 hours (P = .0023), while the 100-mg dose resulted in 21.2% of pain-free patients (P = .0003) compared to 11.8% with placebo.
The co-primary endpoint of absence of the patient’s most bothersome migraine symptom at 2 hours was met by 38.6% of patients in the 50-mg arm (P = .0023) and 37.7% in the 100-mg arm (P = .0023), compared to 27.8% with placebo.
"We are pleased with the favorable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant. We are confident that ubrogepant, an oral CGRP receptor antagonist will be an option for the treatment of migraines in adults," David Nicholson, the chief research and development officer at Allergan, said in a statment. “Allergan remains committed to identifying, developing and bringing to market therapies that address unmet need for patients suffering from this debilitating disease.”
Adverse events (AEs) were consistent with those seen in the placebo group. The most common AEs were nausea, somnolence, and dry mouth, all reported with 5% frequency. All in all, 6 cases with aminotransferase (ALT or AST) elevations greater than 3 times the upper limit of normal were reported, though alternative explanations due to either concomitant illness or medication existed in all cases.
Additional results are expected to be reported throughout 2018, and results of the second phase 3 trial, ACHIEVE II, are expected in the first half of the year, according to Allergan. The filing of a New Drug Application to the US Food and Drug Administration is expected in 2019.
For more extensive coverage pertaining to headaches and migraines, check out MD Magazine's sister site, NeurologyLive. The Clinical Focus page serves as a resource for articles, videos, and information on newly released data and research.
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