FDA Approves New Type of Drug to Treat Migraines

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Lipton’s group published its own study on the drug, released last month.

The study involved nearly 1,700 patients and found that the pill worked better than a placebo pill at halting migraines in progress. Ubrogepant beat placebo treatment in easing pain and other migraine symptoms, such as nausea and sensitivity to light or sound.

Of patients who used the real drug to treat a migraine attack, 22% of those on a higher dose were pain-free within two hours. That compared with 14% of the placebo group. Similarly, 39% of ubrogepant users were free of their “most bothersome” symptom within two hours, versus 27% of placebo users.

The study, funded by drug’s maker, Allergan, was published Nov. 19 in the Journal of the American Medical Association.

According to Lipton, the new gepants could make a “big difference” for certain migraine patients.

They include people who do not get relief from current acute treatments, and those who cannot take the medications because of side effects or safety concerns, Lipton said.

Right now, medications called triptans are the standard treatment for more severe migraine attacks. The drugs, which came out in the 1990s, stop migraines by stimulating receptors for the brain chemical serotonin, which reduces inflammation and constricts blood vessels.

But not everybody responds to the medications. And because of the blood vessel constriction, people at high risk of heart attack or stroke cannot take them.

Triptans also have side effects — like numbness, dizziness and sleepiness — that can make them difficult to take.

Gepants work through a “novel mechanism,” Lipton said, which means they might help some patients who do not respond to triptans. And they do not constrict blood vessels.

Lipton has financial ties to both Allergan and Biohaven Pharmaceuticals, maker of rimegepant.

It will be “exciting” to have new options for patients who cannot take triptans, said a neurologist who was not involved in the study.

“There haven’t been any new acute treatments in a long time,” Dr. Rachel Colman, of Mount Sinai’s Icahn School of Medicine in New York City, said in November.



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