A new class of migraine drugs could mean a "big difference" to those in desperate need of help.
The drug Ubrogepant has not yet been approved by the US Food and Drug Administration Study suggests that this oral pill works safely where other treatments do not.
Within two hours of ingestion, the researchers found that Ubrogepant was able to stop a severe migraine that was significantly better than a placebo and less risky than other drugs.
"Ubrogepant as a potential new drug for the treatment of migraines will be the much needed innovation for a disease that causes time lost millions of people," says neurologist Richard Lipton, a consultant to Allergan, the pharmaceutical company that made the study sponsors.
A debilitating migraine is more than just a bad headache disease, and it's much harder for doctors to treat. More than 38 million people in the US suffer from this neurological disorder, and surveys show that less than a third of them are satisfied with their treatment.
Each patient is slightly different in terms of effective and safe treatment, and in some cases the severity of the cases is limited and may even worsen the situation.
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] Although triptans can relieve pain and inflammation, they also narrow the blood vessels of the body. As a result, these drugs are not safe for people at high risk for heart disease or strokes, and still others do not respond at all.
Nevertheless, there have been no new treatments for acute migraine for a long time. In fact, the FDA recently approved a new class of drugs called panzants that can help stop heavy headaches before they even happen.
Unlike triptans, which target serotonin in the brain, Gepants use monoclonal antibodies to target a molecule called calcitonin gene-related peptide (CGRP), which plays a well-known role in migraine.
So far, only three CGRP inhibitors have been approved by the FDA, and all of these are injections. If Ubrogepant is considered safe and effective enough, it will be one of the first oral remedies that can prevent acute migraine.
In a randomized, double-blind and placebo-controlled Phase 3 clinical trial, researchers tested two different doses of Ubrogepant in 1,686 patients, all of whom reported migraine twice or eight times a month.
Participants were given either a 50 mg, 25 mg or a placebo Ubrogepant tablet. During the trial, 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 insufficient to stop the pain, a second dose was allowed and this was randomized so that the patient received either a placebo or a repeat dose of Ubrogepant. Rescue medications such as paracetamol, NSAIDs, opioids, antiemetics or triptans were only used in cases where both doses did not work.
Of those who took the lower and higher dose of Ubrogepant, over 20 percent were free of pain within two hours. By comparison, placebo only reduced 14 percent.
Eliminating the most annoying symptoms was more difficult and required a higher dose of Ubrogepant. In this case, only those taking 50 mg were significantly better off than those taking the placebo.
"The current results show that 50 mg of Ubrogepant has the potential to reach important treatment goals in the acute treatment of migraine," said Lipton. his colleagues write.
"The mechanism of action of Ubrogepant may make it an option for people who do not respond to currently available drugs."
It is an effective drug but it is not as impressive as other medications that are already on the market. For example, previous studies have shown that triptans can provide a safe and effective response in up to 70 percent of patients within an hour.
Neuroscientist Stephen Silberstein, who was not involved in the study, told CNN that though Ubrogepants may be useful to those who can not tolerate triptans, they are no better and no magical panacea. Instead, it's better to consider Ubrogepant as a promising new treatment option for those patients who have slipped through the crevices.
"For the first time in a long time, we have not received a lot of good news from any news," Silberstein
said. "We chose these new drugs for the acute treatment of migraine and have new migraine-preventive medicines . " However, the long-term safety of these drugs could be approved by the FDA next month, Lipton said.
This study was published in JAMA .