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25-12-2012 | Article

Niacin drug development stops at phase III trial


Merck press release

medwireNews: The pharmaceutical company Merck has decided to no longer pursue Food and Drug Administration (FDA) approval of its niacin-containing cholesterol drug, Tredaptive, after it failed to prevent heart attacks, strokes, and heart procedures in the largest-ever study of the B vitamin.

The study, HPS2-THRIVE, enrolled over 25,000 patients who were at high risk for cardiovascular events. These patients were monitored for almost 4 years to compare the effects of a statin combined with Merck's compound - itself a mix of extended release niacin and laropiprant - to that of statin therapy alone.

HPS2-THRIVE was intended to address shortcomings that the FDA and other experts found with Tredaptive in previous trials, which ultimately led to a rejection of Merck's application in 2008.

This time the therapy fell short of the primary endpoint by failing to reduce the risk for the combination of coronary deaths, non-fatal heart attacks, strokes, or revascularization compared with statin therapy.

"In addition," a Merck press release stated, "there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received extended-release niacin/laropiprant."

As a result, Merck is recommending that providers abstain from starting new patients on Tredaptive in Europe, where it is now under review.

"While we are disappointed in these results, we thank the investigators who have conducted the study and the patients who have participated in it," said Peter Kim, president, Merck Research Laboratories. "We are committed to working closely with the independent research team at Oxford University and with regulatory agencies to understand the results and determine next steps."

The unsuccessful study finding will likely reverberate among companies that produce drugs based on the cardiovascular qualities of niacin, a B vitamin that has been used for decades to elevate high-density lipoprotein, the "good" cholesterol.

According to Forbes, this large-scale study is the second to indicate a failure of niacin to prevent heart attacks and strokes. A 2011 National Institutes of Health study found that Abbott Laboratories' niacin-based extended release medication, Niaspan, failed to prevent heart attacks and slightly raised the risk for stroke when combined with the generic cholesterol-lowering drug, simvastatin. Currently, the drug generates $ 900 million in annual sales.

By Peter Sergo, medwireNews Reporter