Dr. Silberstein, Prof. Goadsby, Dr. Dodick
During the International Headache Congress on September 10, 2009 in Philadelphia, USA, numerous new data on the development of the CGRP antagonists MK-0974 and MK-3207 were presented. These are two CGRP antagonists that are in clinical research programs for the treatment of migraines. CGRP antagonists are seen as the decisive innovation in the treatment of migraines in the coming years. Surprisingly, however, the development of the active ingredient MK-3207 was halted. Further phase IIb and III studies will not be initiated. The effectiveness in previous studies has been proven. However, the investigations made it clear that in individual cases delayed increases in liver values can occur. Due to this situation, the decision was announced on September 10, 2009 not to further develop the CGRP antagonist MK-3207.
The development was regretted by the scientists on the international headache congress, since this means that an option for the supply of headache patients is less available in which great hopes were placed.
Nevertheless, the development of the CGRP antagonist MK-0974 (telcagepant) will continue. The active ingredient MK-0974 is also a novel CGRP receptor antagonist. It has a neuro-like mode of action in that, on the one hand, it can stop migraine attacks, but on the other hand, it does not lead to vasoconstriction and does not work via the serotonin mechanism. CGRP and its receptors are found in many areas of the brain. CGRP is critical for redirecting migraine pain, according to current research. During the migraine attack, CGRP binds to the CGRP receptors and activates them. This transmits pain signals. MK-0974 (telcagepant) is able to block CGRP on the receptors and can thereby stop the transmission of pain signals and migraine attacks.
CGRP antagonists in clinical development
The manufacturing company announced in April 2009 that no application for approval for telcagepant would be submitted due to elevated liver enzymes in individual patients. However, these are studies on the prevention of migraine attacks, whereby the substance was used long-term twice a day for three months to prevent migraines. Liver value increases were also found in three patients. However, the dosage and frequency of use in the studies to prevent migraines were different from the studies in which the drug was used intermittently for the acute treatment of individual migraine attacks.
The current data situation will now be discussed with the approval authorities in order to decide how to proceed.
Further information
http://www.merck.com/newsroom/press_releases/research_and_development/2009_0910.html
Philadelphia Convention Center
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