The new class of migraine medicines can make a "big difference" for people who need a desperate need for relief. Drug 1965 has not yet been approved by the US Food and Drug Administration, but a large-scale clinical study suggests that this oral pill may work safely when other treatments do not.
Within two hours of admission, researchers found that urogheptant could stop severe migraine in its tracks, performing significantly better than placebo and at a lower risk than other drugs.
"Having urobogepant as a potential new drug for acute migraine treatment will provide a much-needed innovation for a disease that causes lost time for millions of people," says neurologist Richard Lipton, a consultant at Allergan, the pharmaceutical company that sponsored the trial.
A debilitating migraine is more than just a bad headache and it is much harder for doctors to treat. In the United States, more than 38 million people suffer from this neurological disease, and studies show that less than one-third are satisfied with their care.
When it comes to effective and safe treatment, each patient is a little different, and in some of the more severe cases, the options are limited and may even make things worse.
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However, there have long been no new treatments for acute migraines. In fact, the FDA has only recently approved a new class of medicines called hepatitis, which can help stop severe headaches before they even begin.
Unlike tryptans, which target serotonin in the brain, hepatents use monoclonal antibodies to target a molecule called calcitonin-related gene peptide (CGRP), which has some role in migraines.
So far, only three CGRP inhibitors have been FDA approved and all are injections. If ubrogepant is thought to be safe and effective enough, it will be one of the first oral hepatitisers to prevent acute migraines.
In a Phase 3 clinical trial that was randomized, double-blind, and placebo-controlled, the researchers tested two different doses of urobogepant on 1686 patients, all of whom reported migraines between 2 and 8 times a month.
Participants were given a tablet of urobhepant containing 50 mg, 25 mg, or placebo. During the test, they were instructed to take one tablet as soon as possible or within 4 hours of the onset of moderate or severe migraine.
If this initial dose was not sufficient to stop the pain, a second dose was allowed and this was randomized so that the patient either received a placebo or a second dose of uroghepant. A "rescue medicine" such as acetaminophen, NSAIDs, opioids, anti-emetics or tryptanes is only used when both doses are not working.
Of all those who received the lower and higher dose of uroghepant, over 20 percent were free of pain within two hours. In comparison, placebo relieves only 14 percent. Getting rid of the most troubling symptoms was a little more difficult and required a higher dose of urogheptant. In this case, only those taking 50 mg were significantly better than those taking placebo.
"The present results indicate that 50 mg of urobogepant has the potential to meet key treatment goals for acute migraine treatment," Lipton and colleagues wrote.
"The mechanism of action of Ubrogepant may make it an option for people who are not responding to currently available drugs."
This is an effective drug, but not as impressive as other drugs already on the market . Previous studies, for example, have shown that within one hour, tryptans can show safe and effective response rates in up to 70 percent of patients.
Neurologist Stephen Silberstein, who did not participate in the study, told CNN that while urogepts may be useful for those who cannot tolerate tryptans, they are no better and are not magical drugs .
Instead, it is better to consider urobogepant as a promising new treatment for those patients who have crept through the cracks.
"For the first time in a long time, we have gone from news to very good news," Silberstein wrote in a recent review of the study.
"We have switched to these new medicines for the acute treatment of migraines and we have new medicines to prevent migraines."
More studies are needed to evaluate the long-term safety of these medicines, but according to Lipton, FDA approval may come next month.
This study was published in by JAMA .