According to Dr. Peter Goadsby:
Now these medications move into Phase 3 trials, which, if successful, means they may come to market in about three years. Phase 3 needs to establish a few things to round things off for the regulators. One needs to study a much larger sample of subjects to make sure the medication really works. Also, looking at a larger sample insures there are no overriding safety concerns. Anecdotally, most experts agree that these medications have a very low side effect profile. Phase 3 will hopefully confirm that critical point.
Not surprisingly, when large studies of this nature are undertaken, other, unexpected outcomes are revealed. We'll share several here. Keep in mind they will need to be validated by the more expansive Phase 3 trials, if not more.
In one study, the monoclonal antibody that targets the CGRP receptor has enhanced subject-reported "wellness" on headache-free days. Subjects report a reduction of fatigue along with enhanced focus, concentration, and improved interaction in daily life , as reported in an abstract presented at the annual meeting of the American Headache Society. So not only migraine prevention/reduction, but better days generally in between doses.
Also on the watch list, Lilly awaits results of a galcanezumab study focusing on chronic cluster headaches before the end of 2016. This should be followed by numbers on episodic headaches by year end 2017. The cluster project is also being tested in the highly charged migraine arena, but could become the first anti-CGRP antibody marketed for cluster headaches. As you know cluster headaches, also known as "suicide headaches" have been stubbornly resistant to medical intervention.
Finally, the study of the action of CGRP monoclonal antibodies and new (2016) genetic findings are still in their infancy, but hold much promise. We still do not understand how the genetic findings are linked to responses to CGRP-blocking antibodies The recent genome wide association (GWA) study results have supplemented the debate concerning site of action of these drugs because the new CGRP antibodies have a molecular size too large to get across the blood brain barrier. The genetic findings therefore call for new study designs, suggesting a focus on vascular control, that may suggest individualized treatment outcomes and new treatment choices. The goal is, naturally more personalized care. However, elegant studies with larger sample sizes and a comprehensive understanding of how infrequent and rare variants influence the disease characteristics, will be required.
So there is your update, and a promising one it is for both migraineurs and cluster sufferers alike. Also, if you are inclined to check out ongoing clinical trials in your area please go to ClinicalTrials.gov
and search for "Migraine CGRP"
You would be helping the research on CGRP in general, along with possible personal migraine benefits.