US FDA REMEMBERS : THE ISSUE OF CORDAPTIVE

Not so long ago, early Jan 2008, we reported that there was much hanky-panky with the " ENHANCE TRIAL " . The Enhance trial tested Vytorin against Simvastatin, in terms of Carotid IMT reduction, you remember? Well, to cut a long story short, MSD / Schering Plough, the sponsors of the study, and also the manufacturer and co-marketer of the drug Vytorin, tried to make that unfavorable Enhance, favorable. In so doing, they offended the US senate. Now, MSD is the manufacturer of Cordaptive, a niacin / laropiprant, combination, that can raise HDL-C without the flushing side effects of Niacin. If you can recall, two years ago, we were all awaiting the Pfizer drug " Torcetrapib " which promised to raise HDL-C as a means of coronary artery protection. Well, Torcetrapib failed us as it raised BP and cause more cardiovascular events then protected. Well Niacin is essentially vitamin B. It does increase HDL-C mildly, but has a difficult side effect of flushing. MSD has found that the flushing can be minimised with the addition of laropiprant ( a phosphodiesterase inhibitor ). They tried this combination and it was successful, increasing HDL-C with minimal or no flushing ( or so we are told ). Well, when MSD applied for FDA approval, it was rejected and FDA asked for more documentation. One wonders whether this denial of approval has anything to do with Enhance? Looks like MSD and cordaptive is in for a hard time. The search of a HDL-C raiser continues.