Reliant Pharmaceuticals
today announced a submission to the U.S. Food and Drug Administration (FDA)
to seek approval for the expanded use of Omacor(R) (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
(greater than or equal to 500 mg/dL) in adult patients. Very high
triglycerides (greater than or equal to 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.
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 omacorrx
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.
omacorrx
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