A new US drug aimed at treating severe migraine has shown positive results in the third phase of clinical trials. The findings were announced Thursday in the New England Journal of Medicine.
The drug, rimegepant, is awaiting the US Food and Drug Administration’s approval to become the alternative of the currently available migraine medications.
Migraine headache affects about 12 to 14 percent of people, or more than a billion individuals worldwide. This chronic neurologic disorder involves periodic attacks of head pain along with symptoms that may include nausea as well as sensitivity to light and sound. Currently, many people with migraine take triptan drugs (examples include sumitriptan, eletriptan, and rizatriptan) which were introduced in the 1990s.
Triptans halt acute migraines by stimulating serotonin receptors, which in turn reduces inflammation. But triptans don't help everyone, they can produce intolerable side effects; and since they constrict vessels, they shouldn't be taken by people with cardiovascular disease (CVD) or major CVD risk factors. Those problems are addressed with the new drug.
The "rimegepant" work by targeting the receptors for a small protein, called CGRP, long implicated in migraine. The drug relieves the pain and other symptoms of migraine by blocking the CGRP pathway.
The third phase of the clinical trials reported in the New England Journal of Medicine assessed the efficiency of the drug in an experiment involving more than 1,000 men and women with migraine at 49 centers in the US.
The participants were instructed to take a tablet of rimegepant, or a matching placebo tablet. Two hours after taking their tablets, 19.6 percent of patients in the rimegepant group were free from pain compared with 12.0 percent in the placebo group, showing a statistically significant difference. Side effects were minimal and no harmful effects were observed on cardiovascular disease.
