The pharmaceutical company Merck & Co., Inc was at the 14th International Headache Congress in September, talking again about the migraine drug Telcagepant. And hopes that Telcagepant will see the light of day aren’t dead yet.
After concerns about using Telcagepant as a migraine preventative, Merck has moved ahead with trials using the new drug as an abortive. Researchers were originally concerned when some patients developed high levels of liver enzymes (transaminases). (more on the background of Telcagepant here)
In one of the new trials, none of the patients had high levels of liver enzymes apparently caused by the drug (you caught that, right? Some did have the problem, but investigators felt it was not drug related.).
Two trials were reported on. First, compared with rizatriptan (Maxalt, Rizaliv, Rizalt), how many "adverse events" would patients experience?
Investigators didn’t look for any side effect here, they only measured events from a predetermined list. The adverse events were not too serious with either group, and there tended to be fewer with Telcagepant.
The problems more common with Telcagepant included nasopharyngitis, upper abdominal pain, and nausea and vomiting. In the other study, patients on telcagepant were more likely to feel sleepy (than those on a placebo). In an earlier study, Telcagepant was less likely to cause nausea than zolmitriptan, so we’ll see how it continues to compare with the triptans on this one.
But did Telcagepant fight symptoms of migraine? Yes, the results still look positive. In a large trial of 1,677 patients, researchers used doses of 140mg or 280mg and measured symptoms after 2 hours. They were interested in pain freedom or pain relief (reduction to mild or none). These charts show the percentage of patients helped at either dose, compared to a placebo:
Merck is preparing to have some major discussions regarding Telcagepant later this year with regulatory agencies. It remains to be seen if this drug will be the next big one for Merck and migraine, though it’s still showing promise.
The bad news is that Merck has shelved MK-3207, it’s other possible oral calcitonin gene-related peptide (CGRP) receptor antagonist for migraine treatment. So research on this type of drug continues to be stop and go for Merck.
However, Dr. David Michelson, vice president of clinical neurosciences, said Merck is still committed to this type of research: "Merck believes that the blocking of CGRP receptors remains an exciting pathway to address the underlying pathophysiology of migraine. We are continuing our efforts to offer patients a new treatment approach."