Two migraine-targeting drugs are in late-stage trials, including one from the Israeli pharmaceuticals company Teva, and at least one of them may be approved as early as next year
A series of clinical trials shows great promise for a new generation of migraine-prevention drugs, which may hit the market within the next year. This is excellent news for the millions of migraine sufferers around the world, whose current treatment options are limited, with no specific drug for this phenomenon that makes so many lives miserable.
Migraine is chiefly associated with headaches, but actually includes a wide range of symptoms, including nausea, vomiting, and fatigue, as well as sensitivity to light and noise. As anyone who has ever coped with recurring migraines knows, there are various drugs on the market, but none of them is specific for migraines. These are drugs that were developed for other conditions, like depression, high blood pressure or epilepsy, and thus have many side effects. This is why a drug specifically targeting migraine makes for exciting news.
Two such drugs were tested in two clinical trials recently published in the prestigious New England Journal of Medicine. The first drug is a specific antibody targeting the receptor for the CGRP protein, which is involved in transmitting the sensation of pain and plays a role in the illness. An antibody is a protein used by our immune system to neutralize specific materials that invade the body. Migraine patients have a 2-fold increase of CGRP in their blood during attacks. This increase is so significant, that CGRP levels in the blood differentiate migraine patients from healthy individuals and people with a non-migraine headache. This indicates that this protein is pivotal in the disease, and therefore neutralizing it may help treatment.
During the trial, the drug, Erenumab, was injected as a preventive treatment for episodic migraine, defined as recurring less than 15 days per month, to 955 patients in 121 different locations. To date, this is the only drug that blocks the CGRP receptor in the brain.
Administered subcutaneously for six months, the drug dramatically reduced the number of migraine attacks: half of the patients who received the high dosage reported a reduction of 50% or more in the number of days per month in which they suffered from a migraine. “The results of [the clinical trial] represent a real transition for migraine patients from poorly understood, repurposed treatments, to a specific migraine-designed therapy,” said lead researcher Peter Goadsby from King’s College Hospital in London in an interview to the website Science Alert.
Another drug, called Fremanezumab, manufactured by the Israeli Teva Pharmaceutical Industries, was tested on 1,130 chronic migraine patients in another clinical trial. Injection of the drug for 12 weeks reduced the number of days per month in which the patients experienced a migraine by one third, from 13.2 on average to 8.5. Unlike Erenumab, this drug targets the CGRP molecule itself, and not its receptor. For both drugs, no significant side effects were reported compared to placebo.
Both experiments showed that the drugs had a significant advantage over the placebo, but additional research regarding long term efficacy and safety are still needed. One thing is for certain – we expect to hear about more CGRP-targeting antibodies, since two other companies are developing their version of such antibodies. At least one of these four companies is expected to put its drug on the market in the coming year. And there is some hope that the competition may reduce the cost of these treatments, which now stands at $8,500 a year at least.
Goadsby told Migraine Action, a British non-profit organization that aids migraine patients, that the development of these novel drugs “Represents an incredibly important step forward for migraine understanding and migraine treatment.” Simon Evans, Chief Executive of Migraine Action added that “Migraine is too often trivialized as just a headache when, in reality, it can be a debilitating, chronic condition that can destroy lives…We hope that this marks the start of real change in how this condition is treated and perceived.”
Translated by Elee Shimshoni