New Data Demonstrates Minimal Interactions Between Omacor(R) (Omega-3-Acid Ethyl Esters) And Simvastatin

Main Category: Statins
Also Included In: Cholesterol;  Cardiovascular / Cardiology
Article Date: 18 Aug 2006 - 0:00 PDT

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Reliant Pharmaceuticals today announced the publication of new data in the July edition of the Journal of Clinical Pharmacology finding the co-administration of Omacor (omega-3-acid ethyl esters) with simvastatin has minimal interaction between the two drugs. Omacor (4 g) plus simvastatin (80 mg) did not significantly affect the steady-state pharmacokinetics of simvastatin and was well-tolerated in healthy patients.(1)

Omacor is the first and only Food and Drug Administration (FDA)-approved omega-3 fatty acid. Omacor was approved by the FDA in November 2004 as an adjunct to diet to reduce very high triglyceride levels (greater than or equal to 500 mg/dL) in adult patients.(2) At that time, Reliant Pharmaceuticals also received an FDA New Drug Application (NDA) approvable letter for Omacor in combination with a statin to treat high triglyceride levels (200-499 mg/dL) in adult patients. To gain final approval, Reliant is conducting a clinical trial to evaluate the efficacy and safety of Omacor as adjunctive therapy to simvastatin for the treatment of high triglycerides.(3)

"Many Americans who receive statin therapy continue to have elevated triglycerides. It's important to evaluate the safety and efficacy of Omacor as adjunctive therapy in these patients," said Robert Shalwitz, MD, Vice President of Clinical Development, Reliant Pharmaceuticals. "Reliant Pharmaceuticals is committed to patient safety and ongoing research for the effective use of Omacor."

About the Study

The open-label, randomized, 2-way crossover, drug-drug interaction study evaluated the impact of Omacor capsules on plasma simvastatin pharmacokinetics in 24 healthy patients. Patients were given 4 g of Omacor co-administered with 80 mg of simvastatin or 80 mg of simvastatin alone.(4) The primary pharmacokinetic end points for the determination of drug interaction were AUC (area under the plasma concentration-time curve over the final 0-24 hour dosing interval) and C(max) (maximum plasma concentration over the final dosing interval) on day 14.(5)

After 14 days of dosing, both the extent and rate of exposure to simvastatin and its major active metabolite, beta-hydroxy simvastatin, were similar after co-administration of Omacor and simvastatin compared with administration of simvastatin alone. Additionally, after single-dose administration, rates of exposure (C(max)) following either treatment were similar for both simvastatin and its beta-hydroxy metabolite. With single dosing, the AUC of simvastatin, but not that of its beta-hydroxy metabolite, increased (by 19% for AUC(0-t) and 24% for AUC(inf)) when Omacor and simvastatin were co-administered.(6)

Important Information About Omacor

-- Omacor is used along with diet to reduce very high triglycerides in adult patients. Before taking Omacor your healthcare provider should help you try to control your high triglyceride level by:

-- Exercising and losing weight if you are overweight.

-- Decreasing alcohol use.

-- Controlling medical problems that can cause high triglyceride levels (such as diabetes mellitus and hypothyroidism).

-- Stopping or changing medicines that can increase triglyceride levels (such as estrogens, thiazide diuretics, beta blockers).

-- 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 check you occasionally to see if an effect has occurred.

-- Some possible side effects of Omacor include belching, infection, flu symptoms, upset stomach, rash and change in your sense of taste. This is not a complete list Omacor side effects.

-- 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 850 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.

References:

(1) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.

(2) OMACOR Prescribing Information, Liberty Corner, NJ: Reliant Pharmaceuticals, Inc.; 2005.

(3) Data on file. Reliant Pharmaceuticals, Inc.

(4) McKenney J, Swearingen D, Di Spirito M, Doyle R, Pantaleon C, Kling D, Shalwitz R. Study of the Pharmacokinetic Interaction Between Simvastatin and Prescription Omega-3-Acid Ethyl Esters. J Clin Pharmacol. 2006; 46:785-791.

(5) Ibid

(6) Ibid

Reliant Pharmaceuticals
http://www.omacorrx.com

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