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“Here, for the first time ever, is a specific treatment for migraine prevention,”
“It’s an enormous step forward.”
– Peter Goadsby, MD, Chief of the University of California, San Francisco Headache Center, and Chairman of the American Headache Society
Finally, after decades of waiting real hope is on the horizon in the form of a small molecule called a Calcitonin Gene-Related Peptide (CGRP) that is involved in pain signaling in the brain during a migraine. The new drugs, called CGRP Antibodies are designed to block the action of CGRPs, and presumably prevent a migraine before it begins. Dr. Peter Goadsby has been on the trail of CGRPs for close to 25 years since he and his team first identified the pain signaling properties inherent in the molecule.
Research into migraine prevention, and a potential market of 36 Million migraineurs, has garnered the attention and efforts of at least four major pharmaceutical firms: Eli Lily, Amgen, Teva and Adler Pharmaceuticals. All four firms report positive results in phase II clinical trials. As recently as yesterday, 7 July 2015, Allergen purchased Pharma giant Merck’s several experimental CGRP antibody treatments in development.
Now it is on to the Phase III Trials, which will involve many more patients and hopefully show significant success and outcomes. Also, Phase III Trials usually randomize the methodology, placing people taking part into treatment groups at random. If the results are encouraging, a random approach is viewed as far more powerful. So in short, Stage II Trials are intermediate between testing a drug for safety, and analyzing how well it works at certain doses before moving on to studies with much larger numbers of people. That’s where we are now, with Phase III Trials planned over the next year.
One of the more significant questions is how much will these drugs cost? Pharmaceutical companies use the first years a drug is on the market to recapture its research and development costs, which are often considerable. That initial time period is protected by patent law. This is why so many drugs drop in price when the protected time period expires, and the drug can be produced as a generic. So it is very difficult to predict cost at this point.
However, we can look to one indicator. Some of the drugs being designed to interfere with CGRP are known as monoclonal antibodies. They are not in pill form. They (at present) must be injected or infused. Currently monoclonal antibodies are used in cancer treatment, and the cost can exceed $10,000 a month. However, it is not certain what the new migraine drugs would cost, and how often and in what form they would need to be administered. Also, from a marketing perspective, a drug you cannot sell to a significant number of the 36 million does not make sense. What does make sense is keeping it within the range of the average migraineur, and allow it to be an insurance benefit. Volume of use may weigh in heavily in the final application. Let us hope.