It was Ben Franklin who quipped that “an ounce of prevention is worth a pound of cure.” Thanks to advances in medical science, prevention can now be measured in milligrams rather than ounces. This is the case with a newly approved medication to prevent migraine headaches, a 70mg once-monthly injection which patients can administer themselves.
Millions of migraine sufferers have been waiting for something new to help them manage the crushing pain of these headaches. For years we have had only a small handful of treatments to offer. But in May the FDA approved the first drug developed specifically for the prevention of migraines. Other drugs have been discovered to help prevent migraines, but were all initially developed for other conditions. But Aimovig® (AIM-oh-vig), the new injectable medication from Amgen and Novartis, hopes to offer a new and better option to suffering patients.
The deputy director for the FDA neurology division said that this new medication “provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition.”
From a pharmacist’s perspective, this is truly a “new” approach to preventing migraines. The active ingredient in Aimovig®, erenumab-aooe, belongs to a whole new category called “CGRP receptor blockers.” The CGRP stands for calcitonin gene-related peptide, a protein that exists naturally in our body. Blood levels of CGRP rise during a migraine. The theory is that they contribute to the pain symptoms that accompany these terrible headaches. Aimovig® blocks the receptors activated by CGRP, and significantly reduces the frequency of migraines when used monthly.
The effectiveness of this new prescription medication was demonstrated in 3 trials involving, in total, over 2,000 migraine sufferers. The gold standard of trials, when it comes to medicine, is what we call a “double-blind, placebo controlled” trial. What this means is that, during the trial, neither the patient nor the doctor knows if the “real” medicine is being administered, or an identical-looking placebo. Patients were also “randomized”, meaning that the decision of “whom” would get the real drug vs. the placebo was not deliberate.
While the results of the study clearly indicate that this treatment is not a “cure” for migraine, they were positive enough to give hope to those who suffer from multiple headaches per month. Participants in the study had anywhere from 1 to 2 fewer migraines per month than compared to the placebo group. The average, in one study, was a reduction by about 6 migraines per month. For some patients headaches were completely eliminated.
Kevin Lenaburg, the Executive Director of the Coalition For Headache and Migraine Patients (CHAMP) said “Today we celebrate the tireless work of researchers to better understand the biology of migraine and their ability to bring a new therapeutic approach to the millions of Americans who are seeking fewer migraine days.”
Both patients and payers are probably curious about the price. According to online information, the list price for a single monthly dose is $575, or nearly $7,000 per year. But if approved by insurance, many commercially insured patients will pay no more than $5 per month, using the Copay Assistance Program offered by the manufacturer.
Side effects from the medication were minimal. A few patients (5% to 6%) noticed a mild burning or stinging and redness at the injection site, which can be the abdomen, thigh or upper arm. Constipation was noted in 1% to 3% of patients, depending on the dose.
Though Aimovig® is not for everyone, it appears that it will help some patients. Prevention still trumps treatment on any day. Patients with questions about this new option should talk to their neurologist.