Late-Stage Trial Yields Promising Results for New Migraine Drug
Wed, April 21, 2021

Late-Stage Trial Yields Promising Results for New Migraine Drug

A new drug for migraines could help relieve the recurring headache and help millions of patients function better, according to results of a large-scale clinical trial / Photo by: dolgachov via 123RF

 

A new drug for migraines could help relieve the recurring headache and help millions of patients function better, according to results of a large-scale clinical trial.

The findings, published in the medical journal JAMA, show that a pill called ubrogepant held off migraine symptoms for up to two hours and can stop the progress of the extreme headache. It has yet to gain approval from the US Food and Drug Administration, but the results of the clinical trial offer a novel treatment option for those who struggle to find relief using current medications.

 

Better Than Placebo

For the study, the researchers recruited 1,686 patients for a randomized clinical trial that sought to determine the efficacy of ubrogepant in treating migraines and comparing it with placebo. About 60 percent of the participants report having severe migraines while the remaining 40 percent said they had moderate pain.

They were randomly given a dose of the drug (25 and 50 mg) and the placebo and were instructed to take the assigned medication as early as they can when a migraine begins forming. The study noted that patients should consume their assigned medication within four hours of onset and, if needed, take a second dose or a rescue drug in two to 48 hours if the pain continued or returned at moderate to severe levels.

By the end of the trial, 20 percent of participants given the drug reported being relieved of the pain within two hours after taking the dose while over 34 percent said they were free of migraine aura symptoms.

Per dosage, 20.7 of patients who took the 25 mg of ubrogepant felt pain-free within two hours of intake while 34.1 percent said they were relieved of bothersome symptoms, CNN reports. Those who took the 50 mg dose had 21.8 percent saying they relieved of the pain and 38.9 saying most of the symptoms had faded.

Participants were randomly given a dose of the drug (25 and 50 mg) and the placebo and were instructed to take the assigned medication as early as they can when a migraine begins forming / Photo by: Dean Drobot via 123RF

 

This is compared to the 14 percent and 27 percent found in the placebo for relieving pain and most bothersome symptoms, respectively, the news agency adds.

"Having ubrogepant as a potential new medication for the acute treatment of migraine will provide much-needed innovation for a disease that causes lost time for millions of people," said Richard B. Lipton, director of the Montefiore Headache Center in New York and a consultant for Allergan, the trial's sponsor company.

Migraines are among the leading causes of disability, Lipton said. Lipton emphasized that patients "need new acute treatments that are efficacious, safe, and tolerable."

While ubrogepant shows promising results, Stephen Silberstein of the Jefferson Headache Center said the new drug is not as effective as triptans. A review from the Institute for Clinical and Economic Review on acute migraine treatments shows that triptan has response rates of 40 percent to 75 percent.

"The study clearly shows the drug is effective," Silberstein said, but noted that it's "an option for patients who can't tolerate triptans."

Making a Big Difference

The migraine is one of the most common diseases in the world, affecting 1.3 billion of the global population. People aged 35 to 39 years are more likely to experience this and women are more likely to have the condition than men, according to Danish pharmaceutical company Lundbeck.

It adds that about 20 percent of people with migraines experience aura symptoms (intense head pain, nausea, and sensitivity to light and sound) and are likely to miss an average of seven days of work or activities a year.

Migraine patients mostly get relief from current acute treatments, including medications called triptans—the standard drug used to relieve severe migraine attacks, according to the MedicalXpress. MedicalXpress is a web-based medical and health news service that features the most comprehensive coverage in the different fields of medicine.

It adds that in stopping migraines, triptans stimulate receptors for the brain chemical serotonin. This chemical then reduces inflammation and constricts blood vessels.

However, some patients may not get relief from these treatments while others can't take such medications due to side effects or safety concerns. This is why the new drug may lead to a "big difference" for these patients, said Lipton.

This could be due to triptan not being effective for them or that the constriction of the blood vessel could put them at risk, especially if they are susceptible to a heart attack or stroke. MedicalXpress says triptans also have side effects like numbness and dizziness that may make it difficult to take them.

But treaments like the ubrogepant work through a "novel mechanism" that could help patients who don't find triptans effective. These medications also don't constrict blood vessels, making them safe for people at risk of heart diseases.

Having new options for patients who can't take triptans will be "exciting," said Rachel Colman, a neurologist of Mount Sinai's Icahn School of Medicine in New York City who was not involved in the study.

"There haven't been any new acute treatments in a long time," Colman added, although she pointed out that there are still questions that need to be answered.

For instance, if the patients' responses to taking the new drug will remain the same over time considering that the recent trial tested the effects of only a single treatment, long-term safety and side effects also need to be determined. However, Colman noted that "so far, the tolerability data looks good."