Companies are racing to be the first to offer drugs that specifically treat and prevent chronic, debilitating headaches Sufferers of chronic migraines may soon see new sources of relief for their pain — several new drugs are rapidly marching their way towards the clinic. Existing treatments for chronic migraines, a condition characterized by 15 or more migraines per month, mainly exist as a secondary benefit of drugs intended to treat other conditions, including depression, epilepsy, and high blood pressure. It’s also not always easy to find a drug that works for every patient. “[These drugs] fell to treating migraine through observation, but they are not primarily migraine drugs. They’re useful, but they bring side effect baggage with them,” Peter Goadsby, a neurologist and headache specialist at the University of California, San Francisco, tells Vocativ. A new type of drug could change all that. In clinical trials, it has been the first to show it could prevented migraines before they started. In a small percentage of patients, migraines disappeared altogether, and with minimal side effects. During a migraine, a compound called calcitonin gene-related peptide, or CGRP, is released in the brain; when the migraine subsides, so does the peptide. CGRP drugs contain antibodies that attack the protein itself, stopping it from binding to receptors in the brain that would cause migraines. In trials, CGRP drugs, which are administered monthly or quarterly via injection, prevented migraines before they started, making it the first type of drug to do so. Goadsby, as well as numerous other migraine experts and patients, are thrilled to have a drug specifically designed to treat migraines. “I’m incredibly excited by the fact that migraine patients will have a migraine treatment that is well-tolerated. It offers them something some have never had” Goadsby says. Pharmaceutical companies are betting big on CGRP drugs—four companies are in varying stages of vetting their drugs before they can come to market. Most recently, Israeli drugmaker Teva reported the results of a large clinical trial for its drug, fremanezumab. Patients that received the injectable drug had 2.5 days fewer days of migraines per month than those on placebo—a promising result. Teva plans to file the drug for approval to the Food and Drug Administration before the end of the year, a spokesperson tells Vocativ. Other companies are hot on Teva’s tail. Eli Lilly released the results from a late-stage clinical trial of its competing drug, galcanezumab, just weeks earlier. In late April, Alder Biopharmaceuticals presented the results from its CGRP drug, Eptinezumab, tested in a slightly earlier phase of a clinical trail. Amgen seems to be leading the pack—it submitted its CGRP drug, Erenumab, for FDA approval last month, though that’s no guarantee that it will be the first to go on sale. Experts estimate that the first CGRP drug may go on sale sometime in 2018. For these companies, time is of the essence — the first drug to go on sale will likely set the bar for others that come after it. “The first drug that comes to market will be used by people pretty quickly, no question,” Goadsby says. Patients haven’t responded to existing treatments will likely be the first in line, he adds. The clinical trails show that the drugs seem safe and effective, so it’s hard for Goadsby to imagine that the FDA won’t approve them. “Something unusual would have to happen,” he says. But there will still be kinks to work out, such as how insurers will cover the drugs, which could cost anywhere from $8,000 to $20,000 per year, The Verge estimates. And, as Stat News points out, the long-term safety of these drugs is still unknown. Some experts are still on the fence. In 2016, Michel Ferrari, a neurologist at Leiden University, told Science Magazine that it was “still too early to judge the efficacy,” of CGRP drugs. He’d be more convinced by the results of the most recent clinical trials if they showed that the new drugs were more effective or better tolerated than standard treatments, or if the people who would respond best to the new drugs could be identified before taking them, he tells Vocativ via email. Still, if CGRP drugs live up to their promise, they may soon offer relief to migraine sufferers in the US and beyond. Migraines affect 37 million Americans, and the debilitating conditions costs American companies an estimated $13 billion in revenue each year. “It’s a win-win for clinicians and for patients,” Goadsby says. “In terms of how much change this could bring, it’s not just taking migraine treatment to the moon, it’s taking it to another solar system.”
