Phase III Immunotherapy trial for migraine shows positive results

Image      Migraines are believed to affect more than 8.5 million people in the UK each year

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. Studies of two of these medicines, given as shots every month or so, found they cut the frequency of the notoriously painful and disabling headaches.

"If approved, this treatment would provide physicians with an important new tool to help prevent migraine, reduce a patient's migraine load, and potentially help patients return to normal" says Dr. Silberstein.

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

The condition is so debilitating it is estimated to lose the United Kingdom economy £2 billion per year in absenteeism.

Migraines, often characterised by an intense headache and sensitivity to light, as well nausea and vomiting, can typically last from four to 72 hours.

Erenumab is one of the anti-migraine drugs that is developed jointly by Novartis and Amgen. Over the course of six months, the 955 trial participants were given 70mg or 140mg doses of Erenumab, or a monthly placebo.

Image    Migraines can last for up to 72 hours
Image Migraines can last for up to 72 hours

The number of days they suffered migraines each month dropped by three to four in the drug groups and almost two in the placebo group. Those on high dose had a migraine days reduction of 3.7 days while those on placebo had a 1.8 days reduction in the migraine days per month.

Migraine headaches affect thousands of Americans and millions worldwide. The peptide is released at high levels during migraine in response to inflammation, and triggers a cascade effect that stimulates more CGRP release.

At baseline, the quarterly group reported a mean of 13.2 headache days, the monthly group reported a mean of 12.8 days, and the placebo group reported a mean of 13.3 days. 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.

Among all patients who had more than a 50 percent reduction in the number of days they experienced either a severe or moderate headache per month, 37.6 percent on the monthly treatment regimen and 40.8 percent on the quarterly treatment regimen had at least a 50 percent reduction in the number of moderate headaches they experienced per month. The data show that fremanezumab quarterly reduced the average number of headache days per month by 4.3 days, while fremanezumab monthly led to a 4.6-day reduction. Erenumab has also been shown to be effective and tolerable over the long term with a safety profile comparable to placebo. There are several medications that are being prescribed for migraines and for many these do not work well.

The drug reduced the days where patients suffered from migraine attacks.

Both drugs have been submitted to the U.S. Food and Drug Administration for approval.

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