Reliant Pharmaceuticals Announces U.S. Launch Of Omacor®, First Prescription Omega-3
Liberty Corner, NJ - Reliant Pharmaceuticals, Inc. recently announced the U.S. launch of its new lipid-regulating drug Omacor® (omega-3-acid ethyl esters) as an adjunct to diet for the treatment of adults with very high levels of triglycerides (TG), defined as 500 milligrams/deciliter (mg/dL) or higher.1 Omacor is the first and only U.S. Food and Drug Administration (FDA)-approved prescription omega-3 fatty acid product clinically proven to reduce very high TG levels, a serious medical condition that affects up to six million Americans.1-4 It is also the first new class of treatment for very high TG levels in more than seven years.
"The launch of Omacor in the United States further demonstrates Reliant's commitment to providing patients with safe and proven cardiovascular and lipid-regulating therapies," said Dr. Ernest Mario, Reliant's Chairman and Chief Executive Officer. "Only Omacor delivers the triglyceride-lowering benefits of omega-3 fatty acids as a pure, clinically proven and FDA-approved prescription drug.1,2,5 The unique, patented manufacturing process for Omacor results in a highly purified, highly concentrated capsule that contains 90 percent omega-3-acid ethyl esters.1,5 Dietary supplements typically contain less than 50 percent omega-3 fatty acids, and, unlike Omacor, are not FDA regulated as to content, purity and clinical benefit as are prescription drugs."6,7
Omacor: Delivering on the Promise of Omega-3 Fatty Acids for Very High Triglyceride Levels
In two randomized, placebo-controlled trials, Omacor 4 grams/day reduced TG levels by a median of 45 percent (p<0.0001) in patients with very high TG levels. Omacor was very well tolerated in controlled studies.1
Each one-gram Omacor gel capsule contains 90 percent omega-3-acid ethyl esters and is available only by prescription.1,2 The FDA-regulated and approved manufacturing process ensures a pure, consistent, proven concentration of omega-3-acid ethyl esters while helping to eliminate concerns about mercury and other environmental toxins.5 Currently, there are no FDA regulations specific to dietary supplements that establish a minimum standard of practice for manufacturing. Dietary supplements are not approved for the treatment of specific diseases or medical conditions.7
"Omacor provides what the supplements lack: the consistency, reliability and established efficacy of a prescription drug," said Christie Ballantyne, M.D., Director of the Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Houston, Texas. "With Omacor, we can effectively lower very high triglyceride levels with the convenience of once-daily dosing and the confidence of a potent, proven, FDA-approved omega-3 medication."
The FDA and the American Heart Association recommend that patients taking higher doses of omega-3 fatty acid products (greater than two and three grams per day, respectively) for the treatment of very high triglyceride levels be managed under a physician's care.8,9
TGs and Health
TGs, along with low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C), comprise the plasma lipid profile, which, when persistently abnormal, can impact cardiovascular health.
An estimated five to six million Americans have very high TG levels, and many more are potentially at risk due to the increasing incidence of obesity and diabetes – major causes of very high TG levels.3,4,10–12 According to a recent survey conducted by KRC Research Inc., nearly half of Americans are not aware of how TGs affect health, and nearly 70 percent have never spoken to their doctor about their TG levels.13
SOURCE: Reliant Pharmaceuticals, Inc