Telcagepant for Migraine - 4/10 Update
Finding an effective Migraine abortive treatment can be challenging, especially for Migraineurs who have any history of or risk factors for stroke and other cardiovascular disease and events. The triptans -- Imitrex, Maxalt, Zomig, Amerge, Relpax, Axert, and Frova -- and the ergotamines -- DHE and Migranal -- all present potential problems for these Migraineurs.
For more than two years now, I've been telling you about a new type of Migraine medication in development; Telcagepant, a CGRP receptor antagonist medication (first know as MK0974). To refresh your memory or to read about this type of medication, see Migraine Abortive Telcagepant Performs Well in Trials.
April, 2010, Update:
Telcagepant has been performing well in Phase III clinical trails for the acute treatment of Migraine, as an abortive medication taken when a Migraine occurs. That's what I reported in the article linked above. In Phase III clinical trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
Merck had also begun clinical trials of Telcagepant as a Migraine preventive medication. Unfortunately in a Phase II clinical trial (where the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety), elevation of some liver enzymes occurred, causing concern about the safety of Telcagepant. The Phase II trial was discontinued, and Merck is currently setting safety protocols for a study to investigate if there are safety issues when Telcagepant is used as an abortive medication.
Will Telcagepant be approved by the FDA for the treatment of Migraine? At this point, nobody knows. It may be that the problem with elevated liver enzymes occurs only with daily use, but at least one additional safety trial will have to be conducted before Merck proceeds to apply to the FDA to approve Telcagepant as an acute treatment, as a Migraine abortive medication. From a personal perspective, and given all I've been able to learn about it, I remain hopeful that Telcagepant will be approved at least as an abortive. This would definitely be a welcome new medication; in fact, a new class of medication for us.
Gever, John. "Migraine Patients to Wait for Triptan Alternative." MedPage Today. abcNews. April 24, 2010.
Hatan, Caitlin. "Migraine relief on the horizon?" CNN. Paging Dr. Gupta. April 22. 2010.
"Understanding Clinical Trials." ClinicalTrials.gov. September 20, 2007.
Medical review by John Claude Krusz, PhD, MD.