Some of the anti-CGRP drugs currently available are taken as pills, and some are injected or infused. Now a new oral drug in the class known as CGRP receptor antagonists has been shown to be effective at preventing migraine. The drug, atogepant, is still in the experimental phase and not yet approved for marketing in the United States. RELATED: How to Treat Migraine and Get Pain Relief
Study Shows Atogepant Significantly Reduces Migraine Days
People with migraine treated with the drug atogepant experienced about four fewer migraine days per month, according to a study published August 19, 2021, in the New England Journal of Medicine. In 873 adults ages 18 to 73 who reported between 7.5 and 7.9 migraine days per month prior to the start of the study, those given the drug for a 12-week period saw their number of days with migraine symptoms decline by more than half, the researchers said. The findings were essentially consistent across three dosing levels: 10, 30, and 60 milligrams (mg). “This study showed all doses of atogepant significantly reduced migraine days over 12 weeks compared with placebo,” notes a coauthor of the study, Jessica Ailani, MD, the director of the Georgetown Headache Center in Washington, DC. A placebo is a fake treatment that offers no clinical benefit. It’s used to compare safety and effectiveness in drug trials. This was a phase 3 clinical trial, the final step in the required research before a drug can be approved for use by the U.S. Food and Drug Administration (FDA). On the basis of the findings of this and other clinical trials, AbbVie, which makes atogepant, has already applied to the FDA for approval. In a press release issued in March, it said it expected the drug to be green-lighted for use in adults who experience between 4 and 14 migraine days per month.
Use of Rescue Medications Reduced During the Study
In this study, Dr. Ailani and her colleagues assigned 214 participants to receive 10 mg of atogepant daily for 12 weeks, while 223 were given a 30 mg dose, and 222 were administered a 60 mg dose over the same period. The remaining 214 participants were treated with a placebo. In all, 56 percent, 59 percent, and 61 percent of the participants in the 10, 30, and 60 mg groups, respectively, saw a 50 percent or more reduction in the three-month average of migraine days per month, according to the researchers. In addition, participants who reported using rescue medication on up to seven days per month prior to the study needed to use these drugs roughly three days per month after 12 weeks of atogepant treatment. Participants who received the drug also had better scores on various assessments designed to measure their ability to perform daily activities with migraine, particularly at higher doses, the researchers noted.
Constipation and Nausea Were the Most Common Side Effects
Just under 54 percent of participants reported side effects that began or worsened during atogepant treatment, though the frequency of these issues was similar in the placebo group as well. The most commonly reported side effects among those given the drug were constipation (affecting 7 to 8 percent of participants at the three doses), nausea (4 to 6 percent), and upper respiratory tract infection (4 to 6 percent). In the placebo group, the most common side effects were upper respiratory tract infection (5 percent of participants), urinary tract infection (4 percent), and colds (4 percent). Serious side effects were reported in two participants who received the 10 mg dose of atogepant — one participant experienced an asthma attack, which was deemed unrelated, and one had inflammation in the optic nerve — and in two participants who received placebo, according to the researchers.
Oral Delivery Makes Atogepant Easy to Use
Notably, unlike the CGRP antibodies, which were also developed to prevent migraine attacks and are administered via injection or infusion (either once a month or once every three months), atogepant is a pill that’s taken orally, once daily, Ailani says. “Atogepant is a once-daily oral medication, making it easy to use for patients,” she says. “And its efficacy seems comparable to other CGRP preventive treatments. That, along with the tolerability, have made this class of medications quickly adopted by patients.”
