A new class of migraine medication can make a "big difference" for those in desperate need of relief.
The drug ubrogepant has not yet been approved by the US Food and Drug Administration, but a large-scale clinical trial suggests that this oral pill can work safely where other treatments do not.
Within two hours of being taken, researchers found that unbrogepant could stop a serious migraine in its tracks, perform significantly better than a placebo and with fewer risks than other drugs.
"Having unbrogepant as a potential new drug for the acute treatment of migraine will provide a sought-after innovation for a disease that causes lost time for millions of people," says neurologist Richard Lipton, a consultant for Allergan, the drug company that sponsors the trial.
A debilitating migraine is more than just a bad headache, and it is much more difficult for doctors to treat. In the United States, more than 38 million people suffer from this neurological disease, and studies show that less than a third are satisfied with their care.
When it comes to effective and safe treatment, every patient is a little different, and in some of the more difficult cases, the options are limited and can even make things worse.
Since the 1990s, triptans have remained the most popular class of migraine drugs for cases where non-disk medicine simply does not work.
But while triptans can help reduce pain and inflammation, they also snap the body's blood vessels. As a result, these drugs are not safe for people at high risk of heart disease or stroke, and still others do not respond to them at all.
Despite this, there have been no new treatments for acute migraine for a long time. In fact, the FDA has only recently approved a new class of medication, called gepants, that can help stop serious headaches before they even begin.
Unlike triptans, which are targeted to brain serotonin, gepant's monoclonal antibodies use to target a molecule called calcitonin-related peptide (CGRP) that has a known role in migraine.
So far, only three CGRP inhibitors have been approved by the FDA and all of these are injections. If unbrogepant is considered safe and effective enough, it will be one of the first oral gepants that can prevent acute migraines.
In a phase 3 clinical trial, which was randomized, double-blind and placebo-controlled, researchers tested two different doses of unbrogepant in 1,686 patients, all of whom reported migraines between 2 and 8 times a month.
Participants received either a tablet of unbrogepant containing 50 mg, 25 mg or placebo. During the trial, they were instructed to take a tablet as soon as possible or within four hours after a moderate or severe migraine began.
If the initial dose was not sufficient to stop the pain, a second dose was allowed, and this was randomized so that the patient received either a placebo or a repeated dose of unbridged. & # 39; Rescue drugs & # 39 ;, such as acetaminophen, NSAIDs, opioids, antiemetics, or triptans, were used only in cases where both doses were not working.
Of all those taking the lower and higher dose of unbrogepant, over 20 percent were free of pain within two hours. By comparison, placebo relieved only 14 percent.
Getting rid of the most troublesome symptoms was a little more difficult and required a higher dose of unbrogant mortgage. In this case, only those who took 50 mg were significantly better than those who received placebo.
"The current results indicate that 50 mg of unbrogepant has the potential to address important treatment goals in the acute treatment of migraine," Lipton and his colleagues write.
"Ubrogepant's mechanism of action may make it an option for people who do not respond to available medication."
It is an effective drug, but it is not as impressive as other medicines already on the market. Previous research, for example, has shown that triptans can show a safe and effective response rate in up to 70 percent of patients within one hour.
Neurologist Stephen Silberstein, who did not participate in the study, told CNN that although bridging mortgages may be useful to those who cannot tolerate triptans, they are no better and are not a magical cure.
Instead, it is better to consider unbrogepant as a promising new treatment for patients who have slipped through the cracks.
"For the first time in a long time, we have gone from no news to lots of good news," Silberstein wrote in a recent review of the research.
"We have gone to these new drugs for emergency treatment of migraines, and we have new drugs to prevent migraines."
Further research will be needed to evaluate the safety of these drugs, but according to Lipton, FDA approval could come next month.
This study was published in JAMA.