A new class of migraine medications can make a "big difference" for people who need relief.
Drug ubrogepantine has not yet been approved by the United States Food and Drug Administration, but a large-scale clinical study suggests that this oral pill can work safely where other treatments are not.
Within two hours, researchers found that ubrogepant could stop signs of severe migraine, perform better than placebo, and were at less risk than other drugs.
Ası The presence of ubrogepant as a potential new drug for the acute treatment of migraine will provide a much-needed innovation for a time-consuming disease for millions of people, nör says Allergan consultant neurologist Richard Lipton.
Attenuating migraines are much more than headaches, and doctors are much more difficult to treat. More than 38 million people in the US suffer from this neurological disease, and less than one-third of polls show that they are satisfied with their care.
When it comes to effective and safe treatment, each patient is slightly different, and in some more serious cases, options are limited and may make things worse.
Since the 1990s, triptans continue to be the most popular classes of migraine medications where OTC medications do not work.
However, while triptans can help reduce pain and inflammation, they also restrict the blood vessels of the body. As a result, these drugs are not safe for people at high risk of heart disease or stroke, and yet others do not respond at all.
However, there has been no new treatment for acute migraine in a long time. In fact, the FDA has recently approved a new class of drugs called gepant, which can help stop severe headaches before they begin.
Unlike triptans targeting serotonin in the brain, gepants use monoclonal antibodies to target a molecule called the calcitonin gene-linked peptide (CGRP), which has a known role in migraines.
So far, only three CGRP inhibitors have been approved by the FDA, and all of them are injection. If the ubrogepant is considered safe and effective enough, it will be one of the first oral orals to prevent acute migraines.
In a randomized, double-blind, placebo-controlled Phase 3 clinical trial, researchers tested two different doses of ubrogepant in 1,686 patients, all of whom reported migraine 2 to 8 times per month.
Participants were given an ubrogepant tablet containing either 50 mg, 25 mg or placebo. During the trial, they were asked to take one tablet as soon as possible or within 4 hours of a moderate or severe migraine.
If this first dose was not sufficient to stop the pain, a second dose was allowed and either a placebo or a repeated dose of ubrogepant was given. Acetaminophen, NSAIDs, opioids, antiemetics or triptans, such as & # 39; rescue medication & # 39; it was used only in cases where both doses did not work.
More than 20 percent of those receiving a lower and higher ubrogepant dose are painless within two hours. In contrast, only 14 percent of placebo relieved.
It was a little more difficult to get rid of the most disturbing symptoms and required a higher dose of ubrogepant. In this case, patients receiving only 50 mg were significantly better than those receiving placebo.
Lipton et al. "Current results show that 50 mg ubrogepan has the potential to address key therapeutic targets in the acute treatment of migraine."
"Ubrogepant's mechanism of action can make it an option for people who don't respond to existing drugs."
It is an effective drug, but not as impressive as other commercially available drugs. For example, previous research has shown that triptans can show safe and effective response rates of up to 70 percent of patients within one hour.
The neurologist Stephen Silberstein, who was not included in the study, told CNN that although ubrogepants could be useful to those who could not tolerate triptans, they were not better and not a magical treatment.
Instead, it is better to consider ubrogepant as a promising new form of treatment for patients who have gone through fractures.
Ber For the first time in a long time, we have passed the good news of no news, Sil Silberstein said in a recent review of the research.
Ik We went to these new medicines for the acute treatment of migraine and we have new medicines to prevent migraine, ”he said.
Further research will be needed to assess the long-term safety of these drugs, but according to Lipton, FDA approval may arrive as early as next month.
This work has been published JAMA.