Ubrogepant-New migraine drug for pain relief within two hours

USA: Migraine sufferers who cannot get relief from existing medications may soon have a novel treatment option, according to ACHIEVE II trial. Ubrogepant, an investigative drug for acute treatment of migraine, helped to relieve pain within 2 hours of its administration in migraine patients.

Ubrogepant is a small molecule oral calcitonin gene-related peptide receptor antagonist. The drug belongs to a new class of medications called CGRP inhibitors that has come to the market in the past year. It has not yet been approved by the U.S. Food and Drug Administration.

Findings of the study, published in the JAMA journal, found that the drug, when administered in migraine patients at the doses of 25 mg and 50 mg, significantly reduced pain at 2 hours compared to placebo. Additionally, only with the 50-mg dose, the drug completely relieved bothersome migraine-associated symptoms at 2 hours.

Migraine headache pain is often described as an intense throbbing or pulsing pain in one area of the head. Migraine is three times more common in women than in men and affects more than 10% of people worldwide. It is often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. Migraine attacks can last for hours to days, and the pain can be so severe that it interferes with daily activities.

Richard B. Lipton, Albert Einstein College of Medicine, Bronx, New York, and colleagues evaluated the efficacy and tolerability of Ubrogepant compared with placebo for acute treatment of a single migraine attack.

Phase 3 multicenter, randomized, double-blind, placebo-controlled, single-attack ACHIEVE II trial was conducted across 99 primary care and research clinics in the US from August 26, 2016, to February 26, 2018. It included 1686 randomized participants with migraine with or without aura, 1465 received study treatment (safety population; mean age, 41.5 years; 90% female); 1355 of 1465 (92.5%) were evaluable for efficacy.  562 received 50 mg Ubrogepant, 561 received 25 mg Ubrogepant and 563 received placebo for a migraine attack of moderate or severe pain intensity.

Co-primary efficacy outcomes were pain freedom and absence of the participant-designated most bothersome migraine-associated symptom (among photophobia, phonophobia, and nausea) at 2 hours after taking the medication.

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Key findings of the study include:

• Pain freedom at 2 hours was reported by 101 of 464 participants (21.8%) in the Ubrogepant 50-mg group, 90 of 435 (20.7%) in the Ubrogepant 25-mg group, and 65 of 456 (14.3%) in the placebo group (absolute difference for 50 mg vs placebo, 7.5%; 25 mg vs placebo, 6.4%).


• Absence of the most bothersome associated symptom at 2 hours was reported by 180 of 463 participants (38.9%) in the Ubrogepant 50-mg group, 148 of 434 (34.1%) in the Ubrogepant 25-mg group, and 125 of 456 (27.4%) in the placebo group (absolute difference for 50 mg vs placebo, 11.5%; 25 mg vs placebo, 6.7%).


• The most common adverse events within 48 hours of any dose were nausea (50 mg, 10 of 488 [2.0%]; 25 mg, 12 of 478 [2.5%]; and placebo, 10 of 499 [2.0%]) and dizziness (50 mg, 7 of 488 [1.4%]; 25 mg, 10 of 478 [2.1%]; placebo, 8 of 499 [1.6%]).

"Among adults with migraine, acute treatment with Ubrogepant compared with placebo led to significantly greater rates of pain freedom at 2 hours with 50-mg and 25-mg doses, and absence of the most bothersome migraine-associated symptom at 2 hours only with the 50-mg dose," wrote the authors.

"Further research is needed to assess the effectiveness of Ubrogepant against other acute treatments for migraine and to evaluate the long-term safety of Ubrogepant among unselected patient populations, they concluded.

The study, "Effect of Ubrogepant vs Placebo on Pain and the Most Bothersome Associated Symptom in the Acute Treatment of Migraine -- The ACHIEVE II Randomized Clinical Trial," is published in the journal JAMA.

DOI: 10.1001/jama.2019.16711