New migraine drug approved by the FDA

It has been a goal to be able to produce a medication that can fight frustrating, debilitating, and painful migraines before they start.  Fortunately, that day has come as the FDA has approved the first of four new migraine medications that claim to do just that.

What is a migraine?

Migraines are characterized by severe head pain often accompanied by other symptoms which could include nausea, vomiting, difficulty speaking, sensitivity to light and sound, throbbing and pulsating pain, and aura. They tend to run in families and can affect people of all ages.  Migraines occur most often in women, people between the ages of 35 and 55, and Caucasians.

Out of the 39 million Americans who live with migraines, more than 4 million of them have at least 15 migraine days each month.   Up to 1 in 5 people who have a migraine are disabled by them preventing them from missing work, family or social events and reducing other activities. 

New medications

The first of the four new medications is called Erenumab (Aimovig).  Aimovig works by targeting calcitonin gene-related peptide (CGRP), a molecule that’s produced in nerve cells of the brain and spinal cord.  It is predicted to help by reducing the number of days with a migraine, improving overall life quality for the estimated 39 million Americans who suffer from migraines. 

This new medication, Aimovig, is a monoclonal antibody given as a shot for people who have four or more migraine days each month.  Research and studies of Aimovig have shown that patients with migraines given this drug, had on average, one to 2 ½ times fewer monthly migraine days either over six months or three months. 

Years of research has shown that CGRP helps transmit pain signals in the brain. Researchers were able to measure the elevated amount of CGRP in the blood in people who had migraines and have always believed that it played an important role in them.  What has been discovered is that CGRP does not cause migraines but it does increase the pain felt by the sufferer by making the nerve cells more sensitive to pain input.  This has been described as being similar to turning up the volume on a radio making it louder and louder.

The key then was to figure out how to turn down or block CGRP to reduce the suffering felt by people with migraines.

Besides Aimovig, three other drugs that target CGRP have been developed:

1.  Fremanezumab – Meant to prevent migraine and cluster headaches, this medication has completed phase III trials and is under review by the FDA with approval expected later this year.

2.  Galcanezumab – Also designed to prevent episodic migraine and cluster headaches, it also has completed phase III trials and is expected to be approved later this year.

3.  Eptinezumab – This one is meant for chronic and frequent migraine prevention.  It is currently in phase III trials and plans to submit an application with the FDA later this year.

Studies show that the monoclonal antibodies cut the number of headache days by 50% or more in about half of the people who use them.  In a small percentage of people, these drugs have eliminated migraine headaches.

Downsides to these medications

Existing medications for migraines often have side effects such as nausea, dry mouth, constipation, numbness, memory loss, and weight gain.  The side effects from the new CGRP drugs generally are mild but can include nasal congestion or pain and redness where you get the shot.  Overall, most people who have received these medications have tolerated them very well which usually results in better adherence and outcomes.

However, there are more pressing concerns in the fact that these new drugs do not work for everybody and for some people they are quite risky.  Safety during pregnancy is a concern as they might cause high blood pressure in some people who take them for a long period of time.  It is also not known of the long-term side effects they could cause.  CGRP receptors are also found in the kidneys, pancreas, adrenal glands and bones and it is not clear how the drugs will affect them after long-term use.

One other downside that will affect anyone who wants to use them is their cost.  For those who have not been able to find relief in current less expensive medications, these monoclonal antibodies will be more for those patients.