Whitehouse Station announced that it had halted Phase III tests, and abandoned a new migrane candidate, the not-so-stylishly-dubbed "MK-3207", related to post-treatment liver test concerns. Reuters' version, this morning:
. . . .Merck on Thursday said it is abandoning an experimental drug to treat acute migraines because the drug caused elevated liver enzyme levels in some cases.
The drug, dubbed MK-3207, is an oral calcitonin gene-related peptide receptor antagonist. The drug was effective, Merck said, but caused liver test abnormalities after the drug was discontinued, and so the company will not pursue Phase III studies.
Merck said it is continuing development of its drug telcagepant, or MK-0974, for the treatment of acute migraines, which is in late-stage trials. . . .
This was not expected to be a blockbuster candidate, in any event, but it does mean Merck spent possibly a half-billion -- for no return, here.
1 comment:
WOW!
Treatment of acute migraines is typically one dose of a drug followed by a second dose an hour later, or with some drugs a couple of doses over a 24 hours period.
Elevated liver transaminases due to direct toxic effects of a drug with cell death with even a few days of dosing of a drug is common and is seen all the time. Typically the balance is such that there is no problems with even continued dosing. You typically only get problems in a few patients in practice with underlying liver disease in combination with other hepatotoxic drugs and with chronic or excessive use. Even Duract which was incredibly hepatotoxic FDA approve approved for use with short term (10 day use) and only took it off the market when prescribers couldn't keep it to that.
FDA and Pharma has even been intentionally been muddying the waters since 2004 or 5 calling anything less than full blown liver failure drug induced liver injury (DILI) and using the term hepatotoxicity to indicate full blown hepatic failure that might necessitate transplantation, even though what they call DILI is hepatotoxicity but simply milder cases.
For a drug to cause hepatotoxicity of a degree that hepatic FAILURE is a concern with 1 or even a couple of doses is as I said WOW!
Salmon
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