July 22, 2018

Jefferson clinical trial shows promise for new migraine therapy

01 December 2017, 06:07 | Rodolfo Wallace

Jefferson clinical trial shows promise for new migraine therapy

Jefferson clinical trial shows promise for new migraine therapy

The drug halved the duration of migraines in around half of those who took it. There are several medications that are being prescribed for migraines and for many these do not work well.

Erenumab is an antibody that alters signaling pathways in the brain called calcitonin gene-related peptide or CGRP in order to prevent migraine attacks. Half of the patients received a high-dose monthly injection of Erenumab.

Paper reference: Goadsby, P et al (2017) A Controlled Trial of Erenumab for Episodic Migraine New England Journal of Medicine (NEJM).

"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".

In a couple of latest studies, two new drugs for migraine headaches have come up to prove their effectiveness in reducing the severity of the condition in persons who have not responded to traditional therapies. One third got the drug each time, another third got the drug the first time and then dummy shots the next two times, and the rest got dummy shots each time. 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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The results of the trial show that treatment with fremanezumab reduced the number of days patients experience headache by an average of 4.3 days with quarterly treatment and 4.6 days with monthly treatment. They tried the drugs in 955 individuals who suffered from migraines.

The 140mg group had a 3.7-day reduction in monthly migraine days vs. a 3.2-day reduction for the 70mg dose group and a 1.8-day reduction for the placebo group. Checking upon migraine headache days, from an average of 13 days a month in all participants, the reduction was 4 to 5 days in those who received fremanezumab injection.

Those receiving the drug reported migraines having a reduced impact on their everyday lives, being able to better complete activities such as getting ready for the day, doing household chores or activities requiring concentration. Thus, they are called monoclonal antibodies. "Targeting CGRP or its receptor is clearly an effective strategy for treating migraine", he said.

Vas Narasimhan, global head of drug development and chief medical officer for Novartis, said: "The results of the STRIVE study add to the evidence for the significant, consistent benefits of erenumab seen across the spectrum of chronic and episodic migraine, including patients who failed on previous preventive treatments". According to the World Health Organisation migraine is the most common neurological condition in the world, affecting between 12 and 15 per cent of people.

Teva Pharmaceutical Industries, the company developing the drug, hopes for US FDA approval in 2018.

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