Merck & Company's new Migraine drug Telcagepant which was recently hoping to win FDA approval, has been delayed. The small phase IIa clinical study was stopped after participants' liver enzymes were high while taking the medication on a daily basis.
Telcagepant is an antagonist of the receptor for calcitonin gene-related peptide (CGRP), a primary neuropeptide involved in the biology of Migraine. Telcagepant blocks the binding of CGRP to receptors within these areas and thereby is believed to block the transmission of pain signals leading to Migraines.
One of the hopeful things about Telcagepant is it doesn't have direct vasoconstrictor properties like triptans (Imitrex, Maxalt, Zomig, etc.) and ergotamines (DHE, Migranal) do. Triptans and ergotamines stop the Migrainous process in the braine and work well, but some Migraineurs with cardiovascular issues, storke or history of stroke, or high blood pressure may not be able to take them.
In this study, participants took Telcagepant twice daily for three months, to see if it would be an effective preventive treatment for Migraine. A small number of patients experienced a higher than normal increase in liver enzymes while taking Telcagepant. This lead researchers to stop the trial and discontinue further exploration as a preventive medication.
Telcagent was initially developed to treat acute Migraine attacks, not prevent episodic attacks. Hopefully, researchers can go back and fine tune the issues with Telcagepant. Migraineurs who need other abortive options are patiently waiting to add it to their toolbox.
Drug Daily Bulletin. "Merck Delays Filing for Migraine Drug Over Potential Liver Toxicity." FDANews: Vol. 6, No. 79. Thursday, April 23, 2009.
LegalBriefs. "New Merck Migrane Drug Causing Headaches for Drug Maker." AttorneyatLaw.com. Thursday April 23, 2009.
Robert, Teri. "Migraine Abortive Telcagepant Performs Well In Trials." MyMigraineConnection. December 1, 2008.
© Nancy Bonk, 2009
Last updated April 25, 2009.
Published On: April 23, 2009