There is no question about the debilitating effects of migraine headaches. For those who are unfortunate enough to experience that discomfort, there is good news. There are clinical studies showing promise for new treatments. One of the newest treatments has already been approved by the FDA.
Targeting the Source
Studies directed at people with migraine headaches revealed that their blood contained high levels of a protein called calcitonin gene-related peptide (CGRP). This protein ishighly involved in the onset of migraine headaches. CGRP doesn’t cause migraine headaches; however, it plays a significant role by helping transmit pain signals in the brain. Research revealed the peptide causes nerve cells to increase sensitivity to pain input. If the CGRP could be blocked, the migraine would be stopped before it began.
Some pharmaceutical companies began researching the possibilities for medication in the 1980s; however, concerns over side effects, in particular damage to the liver, terminatedclinical studies in 2011. Four of the companies continued to explore ways in which the CGRP blocker could be administered while bypassing the liver.
If at First You Don’t Succeed. . .
While a pill form proved to be a problem, further research showed to be promising as injections were developed to deliver a monoclonal antibody. These antibodies are tiny immune molecules. They have been useful in treating cancer patients. In the case of blocking CGRP, they bypass the liver and seem to be effective for nearly three months.
The first of these injectable medicines to be approved by the FDA is Erenumab (Aimovig),offering relief to those who suffer with four or more migraines a month. Approved in May, Aimovig was evaluated by the FDA in three different clinical studies. On average, patients experienced two and a half fewer days with migraines.
Ongoing Clinical Studies
Three other drugs are in the process of going through FDA approval. Galcanezumab has completed the Phase III trials and is expected to be approved later this year. Studies are underway to determine if it is also a viable treatment for cluster headaches.
Crenezumab is also being reviewed for prevention of migraines and it is in Phase III for clinical studies for treatment of cluster headaches. The last of the four drugs being considered this year is Eptinezumab. It is also in Phase III trials. This drug is targeting migraine prevention. Submission for FDA approval is expected later this year.
Clinical studies are a critical component of finding an effective treatment for migraine headaches. DM Clinical Research invites you to look into our programs and consider joining one of our clinical studies in the fight against migraine pain. Contact us today for more information.