New drugs Erenumab and Fremanezumab show promise for migraine


Migraines can last from anything between a few hours and several days, but 50% of patients receiving Erenumab in the trial reported the duration of their migraines being reduced by half.

The exact cause of migraine is still unknown but scientists believe the pain and sensitivity to light associated with the condition is linked to a chemical in the brain called calcitonin gene-related peptide, or CGRP. For the Phase III trial, 1,130 individuals with chronic migraine were randomly assigned to receive to fremanezumab quarterly, fremanezumab monthly, or placebo.

"The burden of illness faced by those with migraine is huge and can negatively impact every facet of their lives underscoring a significant unmet need for new preventive treatment options".

There is an urgent need for new treatment options and erenumab is the first and only fully human monoclonal antibody of its kind created to specifically prevent migraine. By months four to six, there was at least a 50 per cent reduction in the mean number of migraine days per month for about 43 per cent of patients injected under the skin with a 70mg dose of erenumab each month. Both drugs showed effectiveness in reducing the frequency and severity of the migraine headaches in almost 50 percent of the individuals and the manufacturers have submitted the papers and data for approval to the Food and Drug Administration.

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It's not exactly clear how the drugs help disrupt migraines, but CGRP is known to be involved with the way nerves control pain and with blood vessel activity.

One of the stage 3 trials looked at how the monoclonal antibody erenumab treated episodic migraines.

However, those given a placebo also saw benefits, with 26.6% of participants in this group experiencing such a reduction.

The trial "represents an incredibly important step forward for migraine understanding and migraine treatment", said Professor Peter Goadsby, from King's College Hospital, who led the project.

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Migraines are seriously painful, and while most of us get them pretty rarely, there are some people who deal with debilitating headaches each and every day.

In terms of safety, 5 patients in each of the fremanezumab groups reported abnormal hepatic function (1%), and 3 patients reported the same in the placebo group ( 1%).

"The other thing that is exciting about this class of medicines is that most of the drugs we use for migraine prevention act on the brain, and we use drugs that were developed for epilepsy like topiramate or divalproex sodium, which have a lot of side effects", Lipton said. But they may be helpful in persons who have failed to respond to other traditional anti-migraine medications.

"From the adult studies, these drugs appear to be very safe", Hershey said.

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The studies, as well as an accompanying editorial written by Hershey, were published November 29 in the New England Journal of Medicine.