Merck Revises Timeline for MK-0524B with Simvastatin
Merck has said that they will not file an NDA for MK-0524B. It is being co-administered with simvastatin (Zocor ®).
Although the clinical trial schedule has NOT changed, the filing will not take place in 2007 as previously planned.
MK-0524B is an extended release version of niacin along with a flushing inhibitor. Niacin use to be used before the statins came on the market for controlling cholesterol. It works by not only lowering the LDL but also raising the HDL (good cholesterol). The main problem was the flushing the niacin causes and many patients quite taking niacin because of this side effect. I personally take niacin (over-the counter; OTC) in a non-flushing formulation since my total cholesterol is low but my HDL is very low so the ratio is not what it should be. I’ve been taking 500 mg twice daily for about a year now and am interested to see what the cholesterol levels are next time they are checked.
It is interesting that Merck is not comparing their new drug against a cheap OTC non-fluhing formulation of niacin. It is interesting that the drug would appear to be a triple combination; MK-0582A (an extended release version of niacin), a DP-1 selective antagonist (prevents flushing) and simvastatin.
Further Information
• Merck Revises Regulatory Filing Timeline for MK-0524B, an Investigational Fixed-Dose Combination of MK-0524A and Simvastatin
• Merck MK-0524B - Yahoo! Search Results
• Yahoo! News Search Results for Merck MK-0524B
• Merck MK-0524B - Google News
Technorati Tags: Merck, MK-0524B, niacin, simvastatin, Zocor
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