Positive Findings for 2 New Migraine Prevention Agents

Two new agents using a novel mechanism of action for the prevention of migraine headaches are the subject of interest after phase 2 studies of the drugs showed promising results. Both drugs are monoclonal antibodies directed against calcitonin gene related peptides (CGRP). The findings were presented at the American Academy of Neurology (AAN) annual meeting in Philadelphia.

Peter Goadsby, MD, professor of neurology at the University of California San Francisco and Kings College London, United Kingdom, was involved in both studies and called the research a new era for migraine.

“Migraine remains poorly treated, and there are few effective and well tolerated treatments approved that prevent attacks from occurring,” David Dodick, MD, of Mayo Clinic Arizona in Phoenix and a member of the AAN, who was also an author on both studies, said in a statement. “There is a huge treatment need for migraine—the third most common and seventh most disabling medical disorder in the world.”

Goadsby said CGRP is a crucial transmitter to pathways involved in migraine in the brainstem, the midbrain, and the thalamus. The drugs target CGRP and are administered by subcutaneous injection twice a month or by intravenous injection once every 3 months. Both showed significant reductions in migraine attacks versus placebo.

So far there have been only minor adverse events associated with the 2 new migraine-preventive drugs, said Goadsby.

The drugs are ALD-403 (Alder Pharmaceuticals) and LY2951742 (Arteaus).

In the ALD-403 study, which involved 163 patients with migraine from 5 to 14 days per month, those who received the drug had 5.6 fewer migraines per month, on average. Those who received the placebo reported 4.6 fewer migraines. Furthermore, 16 of the patients who were given ALD-403 had no migraine at 12 weeks. None of the placebo patients were migraine free.

In the LY2951742 study, 217 people with migraine 4 to 14 days per month received biweekly subcutaneous injections of either the drug or the placebo. Those who received the drug reported a 63% decrease in migraine, while those on the placebo had a 42% decrease.

The researchers conclude that the safety and robust efficacy results in this study are promising and justify the conduct of larger, randomized, placebo-controlled phase 3 studies.

“We’re cautiously optimistic that a new era of mechanism-based migraine prevention is beginning,” Dodick said.