Medically reviewed by Susan Kerrigan, MD and Marianne Madsen
It may not be a one-size-fits-all solution for those who suffer from migraines, but atogepant, a prospective drug currently being developed by AbbVie, lowered migraine days in a recent study with statistical significance and showed optimistic results. The novel oral medication “is the first in the gepant class of migraine drugs” with the sole purpose of preventing migraines. The drug class, calcitonin gene-related peptide (CGRP) receptor antagonists, blocks the peptide’s activity associated with migraine pain in the CNS.
Although other drugs in the gepant class exist to treat migraines and have a similar degree of effectiveness, atogepant is the first one used specifically to prevent the onset of migraine attacks, rather than just stop them as they occur.
Study Results
In the Phase 3 study, migraine events decreased to “about four fewer migraine days per month” in participants that received the experimental drug. According to the researchers, the 873 participants (aged 18-73) who documented an average of 7.5-7.9 migraines days per month before starting the study experienced a reduction of migraines by more than half when compared to placebo. In other words, more than 55% of the participants across the different dosages (10, 30, and 60 mg) experienced at least a 50% decrease in migraine days per month in the three-month interval of the study.
Another optimistic discovery is the reduction of the use of rescue medications. Individuals who used rescue medications found that they needed less supplemental therapy, a drop from up to seven days a month before the study to an average of three days a month after 12 weeks of atogepant treatment. Notably, the participants also had improved scores on a variety of assessments to determine their capacity to perform day-to-day activities with migraines.
Common Side Effects Found
Like any other medication, atogepant treatment came with side effects, with the most common being constipation (7-8%), nausea (4-6%), and upper respiratory tract infection (4-6%). About 54% of individuals described experiencing side effects that started during treatment or became worse throughout treatment. However, the incidence of the side effects was close to what was seen in the placebo group.
Two participants experienced alarming side effects: an asthma attack that was regarded as unrelated to treatment and inflammation in the optic nerve.
Dosage Administration Made Easy
In contrast to CGRP antibodies that are given intravenously or by injection, atogepant is an oral pill that is to be taken once daily, making it easier for patients. Jessica Ailani, MD, director of the Georgetown Headache Center in Washington, D.C., discussed the efficacy of atogepant: “. . . its efficacy seems comparable to other CGRP preventive treatments. That, along with the tolerability, have made this class of medications quickly adopted by patients.”
With the recent clinical trial results, AbbVie anticipates FDA approval of atogepant, which is currently indicated for adults who experience a range of 4-14 migraine days per month.
References
- New CGRP Receptor Antagonist Shows Promise as a Migraine Preventive
- U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine
- Atogepant for the Preventive Treatment of Migraine
- Gepants – Tepper – 2020 – Headache: The Journal of Head and Face Pain – Wiley Online Library