August 4, 2018

New Developments in Migraine Medications

Migraines impact an estimated 37 million Americans, and there has been a great demand for medications that could provide relief. Specifically in workers’ compensation, migraines can arise as the result of traumatic head injury, or certain injuries can exacerbate preexisting migraine conditions.

Current drug development research has given rise to a new class of migraine medications called calcitonin gene-related peptide (CGRP) blockers. When experiencing migraines, individuals have been found to have high levels of CGRPs in their blood and it has been theorized that blocking CGRPs could reduce or limit migraine activity. Drug developers found initial success with CGRP blockers several years ago, but the discovery of accompanying liver issues slowed progress until molecules that bypassed the liver could be formulated.

In May, the FDA approved Aimovig (erenumab-aooe), a once-monthly, self-administered injection for the preventive treatment of migraine in adults. The drug, which works by blocking CGRPs, was approved after clinical trials for Aimovig resulted in a range of one to two-and-a-half fewer migraine days per month when compared to patients receiving placebos.

This drug approval signals that more CGRP blockers could be approved soon, as several other drug developers have created similar products that have tested well clinically.

Fremanezumab (also known as TEV-48125) is a CGRP blocker currently being reviewed by the FDA with a decision date of September 16, 2018. While this drug halted Phase 3 clinical trials for cluster headaches, its application for migraines is still favorable. One Phase 3 trial involving 1,130 patients found that fremanezumab reduced the average number of monthly migraine days during a 12-week period by at least four days, varying depending on dose schedule.

Emgality (galcanezumab, and also known as LY2951742) is another CGRP blocker developed to prevent chronic and episodic migraine. It has also completed Phase 3 clinical trials and is currently being reviewed by the FDA, with an expected decision date before the end of September. In a series of Phase 3, randomized, double-blind, placebo-controlled trials, Emgality was found to reduce the number of monthly migraine headaches by at least 50% in patients who previously failed two or more preventive treatments.

Lasmiditan (also known as LY573144) is currently in Phase 3 trials for the acute treatment of migraines, and trials results so far have found that at 2-hours post dose, significantly greater portions of test patients experience migraine relief when compared to placebo patients.

Eptinezumab (also known as ALD403) is in the middle of Phase 3 trials for the prevention of migraine, and one of those trials found that patients taking eptinezumab for six months experienced an average reduction of 8.8 monthly migraine days following their second quarterly infusion. Twenty-one percent of patients who took epitnezumab for six months experienced a 100% reduction in migraine days per month, while 64% of patients taking epitenezumab experienced a 50% reduction in migraine days per month.

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