The U.S. Food and Drug Administration (FDA) has approved the first oral calcitonin gene-related peptide (CGRP) antagonists for acute migraine treatment as new migraine drugs continue to flood the U.S. market,media reported.
In early 2018, the FDA approved the first CGRP antagonist to treat migraines. The milestone was approved to introduce a completely new class of drugs in the U.S. market to block key CGRP receptors in the brain, which are known to play a major role in the onset of migraines. Since then, several other CGRP antagonists have been approved, but these first-wave drugs are expensive and require injections.
Now the FDA has approved the first oral CGRP antagonist, designed to be used at the beginning of a migraine attack. The new oral migraine drug, called Ubrelvy, is competing with its main rival, Rimegepant.
Ulbrevy’s Phase 3 clinical trial results are not impressive. The trial sits indeed reporting statistically significant results, but questions have been raised about the practical clinical significance of these results. The main measure of efficacy was whether the pain of migraines could be relieved within two hours of administration, compared with a placebo result of 11 to 14 percent.
A minor measure defined as “relief from the most painful migraine-related symptoms within two hours” and only a slight improvement indicated that the cohort’s efficacy was close to 40 percent. Although the placebo group reported nearly 30 percent of efficacy issues, questions about clinical significance could be raised again.
Looking at these results, as well as the initial three issues from other oral CGRP antagonists on the market, two neurologists published an article in the journal Headache last year suggesting that the new drug, called gepants, resembled “the emperor’s new clothes.”
“Is the role of ubrogepant and rimegepant clinically relevant? They appear to be much less effective than quortan drugs, and much less effective than painkillers that are not needed with a prescription. They are speculative in their claim that they are more safe or tolerable than quputan, and may be associated with only a small number of migraine sufferers. Therefore, we find it reasonable to suggest that it is difficult to see the emperor’s new gepant. “
Thousands of Americans suffer from migraines each year, and analysts suggest the market for these new oral CGRP oral drugs could reach billions. Despite questions about the broader effects, the FDA believes the new drugs will help a large number of other patients who currently have no treatment options available.
Billy Dunn, acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Treatment, said: “Ubrelvy is an important new option for acute treatment of migraines in adults because it is the first of its kind to be used for this indication. The FDA is pleased to approve a novel treatment for migraine sufferers and will continue to work with stakeholders to promote the development of new safe and effective migraine treatments. “