Ouch! Tredaptive HPS2-THRIVE Study: Fails Primary Endpoint

SGP-MRK-Tred-2012 Well, THRIVE was a large, highly-powered study — 25,000 subjects. This is definitive, then. And there was a signal of harm from niacin. Goodness.

Indeed, Tredaptive has had a rathered checkered submittal past at FDA — significantly delayed in 2008; now no longer even being considered by Whitehouse Station — for an NDA filing here in the States.

It is approved in the EU, if memory serves — but will now likely see steep declines in revenue, since it appears that it doesn’t improve CV outcomes in any statistically significant way. Here it is, per Yahoo news:

. . . .Tredaptive™ (extended-release niacin/laropiprant) did not meet its primary endpoint. Merck and the investigators are informing regulatory agencies of these results. The company is also preparing communications to health care providers in countries where the medicine is currently available, and will continue to work with regulators to provide updated information to health care providers. Based on the current understanding of these new data and until further analyses can be completed, Merck is recommending that providers not start new patients on Tredaptive. Merck does not plan to seek regulatory approval for the medicine in the United States. . . .

The Food and Drug Administration shocked legacy Merck Schering-Plough in 2008 — by withholding approval of Tredaptive over concerns about the side effects of its key component, niacin.

That seems to have been a sensible move, now that the THRIVE results are known.

Do stay tuned  — as Merck is off about $1.30 in NASDAQ premarket trading this morning.


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