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Treatment with ubrogepant (Allergan, Madison, NJ) resulted in similar magnitudes of pain relief for participants who had triptan-nonreponsive migraine (n ~1,000), triptan-responsive migraine, or who were naïve to triptan treatment. Individuals in the triptan-nonresponsive group included primarily people for whom triptans had been ineffective (~80%), with some having intolerability to triptans (~17%) and a few having contraindications (~3%). Treatment-emergent adverse events were not serious and were also similar amongst the 3 groups and those who took placebo.
In the ACHIEVE II trial, adults with migraine who took 50 mg of ubrogepant to treat a single migraine attack had more freedom from pain (21.8 %) vs those who took placebo (14.3 %, P = .013). Relief from most bothersome symptoms (MBS) for those who took 50 mg of ubrogepant was 38.9% vs 27.4% for placebo (adjusted P = .0129). Of participants who took the 50 mg dose of ubrogepant, 62.7% achieved pain relief at 2 hours vs 48.2% with placebo (adjusted P = .013). A lower dose of ubrogepant (25 mg) was superior to placebo for pain relief but not MBS. Ubrogepant was well tolerated and side effects were similar to that seen with placebo.
Return to normal function and satisfaction with treatment was higher in people who took ubrogepant vs placebo. Of those taking 50 mg ubrogepant, 41% reported normal function (P = .001, .012) 2 hours after treatment, and 36% to 38%, respectively (P < .0001), reported overall satisfaction with treatment.
Joel Trugman, MD, clinical development lead for the agent at Allergan said, “we are excited to have a well-tolerated drug that provides efficacy rapidly with potential to work for people whose migraines don’t respond to triptans. We continue working with the Food and Drug Administration (FDA) on the new drug application for ubrogepant, which is accepted and under review with a decision expected in the fourth quarter of 2019.”
These data come from the ACHIEVE I (NCT02828020), and ACHIEVE II (NCT02867709) trials, studies of efficacy and safety of ubrogepant (Allergan, Madison, NJ) for acute migraine treatment. Data were presented at the American Academy of Neurology Annual Meeting May 4-10 in Philadelphia, PA. Ubrogepant, is a novel small molecule calcitonin gene-related peptide (CGRP) receptor antagonist taken orally that is under investigation for acute migraine treatment.
In long-term safety evaluations of open-label intermittent high-frequency use to treat 21,454 migraine attacks with 31,968 doses (50 or 100 mg), ubrogepant was well-tolerated with no identified safety concerns. Notably, just 12% of participants reported using another rescue medication after taking 1 to 2 doses of ubrogepant. There were 20 cases of elevated AST or ALT (4 in the usual-care control arm), all of which resolved in those who continued taking the medication. An independent expert panel, blinded to treatment, judged only 1 case (100-mg dose) as probably related, although confounding factors were noted; 2 cases (both 50-mg dose) were judged as possibly related. Multiple safety studies of ubrogepant taken by healthy volunteers show that daily or intermittent doses of ubrogepant did not cause elevation of ALT or AST or prolongation of QT intervals.
Cynthia E. Armand, MD; Alina Masters-Israilov, MD; and Richard B. Lipton, MD
Saif A. Bushnaq, MD; and Sunil A. Sheth, MD
Charisse Litchman, MD, FAHS; and Sirisha Sanamandra, MBBS