Merck recently announced they are withdrawing their efforts to win FDA approval for their novel Migraine medication Telcagepant. This is disappointing news for the Migraine community as we haven't had a novel drug approved for Migraine in 49 years.
Telcagepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that works without the vasoconstriction of triptans. This medication might have given Migraineurs another option if triptans (Imitrex, Maxalt, Zomig, etc.) and ergotamines (DHE 45, Migranal Nasal Spray, etc.) are contraindicated to use due to cardiovascular disease or other conditions. Currently Migraineurs are limited with their abortive medication choices, especially since Midrin and its equivalents have been taken off the market.
Merck dropped Telcagepant after the completion and evaluation of a failed six-month Phase III clinical trial. Merck has stated only,
"Merck is discontinuing the clinical development program for telcagepant, the company's investigational calcitonin gene-related peptide receptor antagonist for the treatment of acute migraine. The decision is based on an assessment of data across the clinical program, including findings from a recently completed six-month Phase III study."1
It's suspected that they may have withdrawn its FDA application for the second time due to issues with participants liver enzymes being higher than normal. They had a similar issue with another CPRG drug, MK-3207 a few years ago. Another issue may be that the patent for Maxalt is expiring this year and a competitor has a generic ready to go.
Any way you look at it, this news still leaves a gaping hole in some Migraineurs' toolboxes. Triptans don't work for everyone. Other options to abort a Migraine attack include Migranal Nasal Spray or DHE injections that you can give yourself at home. There are a few other ergotamine medications, but Migranal and DHE are the most frequently prescribed ergotamine medications.
1 Press Release. "Merck Announces Second Quarter 2011 Financial Results." Whitehouse Station, N.J. July 29, 2011.
2 McBride, Ryan. "Merck kills PhIII migraine drug program". FierceBiotech. July 29, 2011.
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Last updated August 1, 2011.