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Recent News and Articles on the Keywords: new + omacor + data  Related to the article below (Last Update: 8/5/2008)

Q2 2008: Pronova BioPharma's best quarter
MarketWatch -
The rapid growth in end-user sales, in addition to a continued increase in worldwide demand, further highlights the blockbuster potential of Omacor/Lovaza. ...OSL:PRON - OTC:CMTX
Source: Google News

[CITATION] Reliant Pharmaceuticals submits new data to FDA supporting use of Omacor [R](omega-3-acid ethyl …
R Pharmaceuticals

Omacor Effects on Serum Lipids and Clinical Outcome -
MK Ito, J Marrs, C Williams - The American Journal of Cardiology, 2007 - Elsevier
... esters; Reliant Pharmaceuticals, Inc., Liberty Corner, New Jersey). ... that it important
to note that Omacor was not ... from the 4 trials with outcome data (Table 5 ...

[CITATION] New Medicine Report Omega-3-acid ethyl esters (Omacor)
E Reviewed, A Effects?
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Fish Oil Composition of Omacor and the GISSI Trial -
H Bays - The American Journal of Cardiology, 2007 - Elsevier
... 1 (the ratio found in Omacor [Reliant Pharmaceuticals, Inc., Liberty Corner, New
Jersey]), not ... the clinical end point data currently available ...
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[CITATION] Changes in Lipoprotein-Associated Phospholipase A2 During Treatment With Omega-3-Acid Ethyl Esters: …
CME Tracker
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[PDF] Therapeutic Class Review SM Omega-3 acid ethyl esters (Omacor?) February 2006
AT Alternatives - regencerx.com
... New Product for Review ... Additionally, off-label uses specifically related to Omacor
may include cystic ... AWP (average wholesale price) based on First Data Bank as ...

[PDF] update -
B Drug, G Drug, FIG Utilization - BID - hsc.wvu.edu
... Limited data has been made available concerning the effects of Omacor ? on ... with mixed
dyslipidemia should be cau- tious of Omacor ? as it has ... NEW DRUG UPDATE ...

Omacor in familial combined hyperlipidemia: effects on lipids and low density lipoprotein subclasses -
L Calabresi, D Donati, F Pazzucconi, CR Sirtori, G … - Atherosclerosis, 2000 - Elsevier
... to Cite or Link Using DOI (Opens New Window) Copyright ... line) took placebo first and
then Omacor; the other ... Data are reported as means?SEM; SEM markers falling ...

Oh my, Omacor. -
MR COHEN, MS RPh - Nursing, 2006 - nursing2004.com
... A new drug, Omacor, prescribed to reduce very high ... letters to express the drug names
(OMacOR and AMicAR ... Data suggest that deficiencies in the use and monitoring ...

[PDF] Oh my, Omacor. MEDICATION ERRORS -
MRRP COHEN - Nursing, 2006 - nursing2003.com
... A new drug, Omacor, prescribed to reduce very high ... letters to express the drug names
(OMacOR and AMicAR ... Data suggest that deficiencies in the use and monitoring ...
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Source: Google Scholar
 
 

New Data Submitted To FDA Supporting Use Of Omacor With A Statin To Reduce High Triglycerides

Article Date: 14 Dec 2006 - 0:00 PST
Reliant Pharmaceuticals today announced a submission to the U.S. Food and Drug Administration (FDA) to seek approval for the expanded use of Omacor (omega-3-acid ethyl esters) as an adjunct to diet and statin therapy in adults whose triglyceride levels are high (200-499 mg/dL).  As part of this filing, Reliant submitted new data from the recently completed Combination of Omacor and Simvastatin (COMBOS) trial that evaluated the efficacy and safety of Omacor as an adjunct to diet and simvastatin therapy for the treatment of high triglycerides.  COMBOS is a randomized, double-blind, placebo-controlled, parallel-group study including 254 patients.

"Currently, Omacor may help up to 5 million Americans whose triglyceride levels are very high," said Steven Ketchum, Ph.D., Senior Vice President, Research and Development, Reliant Pharmaceuticals.  "There are an estimated 27 million Americans who struggle to control high triglycerides.  By seeking this expanded indication, Omacor may serve as a safe, new treatment option for adults whose triglyceride levels remain high in spite of statin therapy."

Omacor is the first and only FDA-approved, prescription omega-3 fatty acid product, and has been proven safe and effective in clinical studies as an adjunct to diet to reduce very high triglycerides (≥500 mg/dL) in adult patients.  Very high triglycerides (≥500 mg/dL) impact 4-5 million people in the United States.  Omacor contains the key omega-3 components, eicosapentaenoic acid (465 mg) and docosahexaenoic acid (375 mg), to reduce very high triglycerides, and is naturally derived through a unique, patented process that consistently creates a highly concentrated and purified prescription medicine.

When Omacor was granted FDA approval in 2004, the FDA issued an approvable letter for the use of Omacor as an adjunct to diet and statin therapy to reduce high triglyceride levels (200-499 mg/dL) in adult patients.  Submission of this response is intended to demonstrate the safety and efficacy of the expanded use of Omacor before FDA approval is granted.

Article continues below and (thank you)
 
About High Triglycerides

Like the other types of cholesterol, triglycerides are fats (lipids) that, in balanced and moderate amounts, perform significant and important functions in the body. Triglycerides are derived from either fats ingested from food or other energy sources like carbohydrates in the body.  After a meal, the calories that are not used immediately by tissues are then converted into triglycerides and distributed among fat cells to be stored.  Hormones found in the body then regulate the release of triglycerides from fat tissue so they may be used for energy between meals.  According to the American Heart Association (AHA), a normal level of triglycerides is below 150 mg/dL.  Like cholesterol, triglyceride levels can be detected by a blood test.  A high triglyceride level causes a condition known as hypertriglyceridemia, which is linked to the occurrence of heart disease in some people.

  Important Omacor Safety Information

Omacor is used along with a low-fat and low-cholesterol diet to lower very high triglycerides (fats) in adults. Before taking Omacor, your healthcare provider should help you try to control your very high triglyceride levels by: losing weight if you are overweight, increasing physical exercise, lowering alcohol use, treating diseases such as diabetes and low thyroid hormone levels (hypothyroidism), and adjusting other medications that may raise triglyceride levels such as certain blood pressure medications and estrogens.

  Omacor should be used with caution in people allergic to fish.  Treatment to reduce very high triglyceride levels may result in elevations in LDL-C and non-HDL-C in some individuals.  The effect of Omacor on cardiovascular morbidity and mortality in patients with very high triglyceride levels has not been determined.

  Tell your healthcare provider about all your medical conditions, including if you have liver problems, are pregnant, are trying to become pregnant or are breast-feeding.  Tell your healthcare provider if you take blood thinners.  If you take both Omacor and a blood thinner, your healthcare provider should monitor your clinical response.

  The most common side effects observed in Omacor clinical trials were belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste. 

  For more detailed information about Omacor, ask your healthcare provider or go to http://www.omacorrx.com.

  About Reliant Pharmaceuticals

Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products.  Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States.  Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development.  Reliant's sales force infrastructure is comprised of approximately 825 sales professionals nationwide.

  "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995.

  To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
 

Do Low-Fat Foods Make Us Fat?

Recent Cornell studies in movie theatres, holiday receptions, and homes showed people eat an average of 28% more total calories when they eat low-fat snacks than regular ones. "Obese people can eat up to 45% more," reports lead researcher Brian Wansink (Ph.D.), in the book, Mindless Eating: Why We Eat More Than We Think.

"People don't realize that low-fat foods are not always low-calorie foods," says Wansink. Fat is often replaced with sugar. Low-fat snacks are an average of 11% lower in calories, but people wrongly believe they are around 40% lower.

In one study, two groups of people attending a holiday open-house were given identical regular chocolates that were labeled as either "Regular" or as "Low-fat." People served themselves an average of a third more of the candies, which would have translated into 28% more calories if they had actually been low-fat. A second study showed this is because "people believe they will feel less guilty eating the low-fat foods, so they tend to overindulge, says Pierre Chandon, co-author and marketing professor at INSEAD in France. Fat is often replaced with sugar.

The complete set of research studies, published in the November issue of the Journal of Marketing Research, was cited by the Economist as one of two significant noteworthy studies published that month. It is titled, "Can 'Low-Fat' Foods Lead to Obesity""

For policy makers and companies, the message is that new "low-fat" foods are unlikely to solve the obesity solution. People are very likely to over eat a low-fat foods - even if they don't like them as much as the regular versions.

For dieters, there's also clear message. As Wansink advises in the book Mindless Eating, "Stick with the regular version, but eat a little bit less. It's better for both your diet and your taste buds."

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Contact: Sandra Cuellar
Cornell Food & Brand Lab
 
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