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 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 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
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