Epanova (omega-3-carboxylic acids)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved May 2014

Specific Treatments:

hypertriglyceridemia

Therapeutic Areas

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General Information

Epanova (omega-3-carboxylic acids) is a lipid-regulating agent containing fish oil-derived free fatty acids, designated omega-3-carboxylic acids, with at least 850 mg of polyunsaturated fatty acids, including multiple omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA].

Epanova is specifically indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia.

Epanova is supplied as a capsule for oral administration. The recommended dose is 2 grams (2 capsules) or 4 grams (4 capsules) once daily. The dosage should be individualized according to the patient’s response and tolerability.

Clinical Results

FDA Approval
The FDA approval of Epanova was based on a 12-week randomized, placebo (olive oil)-controlled, double-blind, parallel-group trial. After a wash-out period of lipid-altering medications other than statins and ezetimibe, patients whose TG levels were between 500 and 2,000 mg/dL were randomly assigned to placebo or Epanova 2, 3, or 4 grams per day. Overall, the median baseline triglyceride level was 694 mg/dL. Median baseline non-HDL-C, LDL-C, and HDL-C levels were 217 mg/dL, 81 mg/dL, and 28 mg/dL, respectively. Treatment with Epanova led to statistically significant reductions in fasting TG levels and statistically significant reductions in non-HDL-C levels compared with placebo, but increased LDL-C levels.

Side Effects

Adverse effects associated with the use of Epanova may include, but are not limited to, the following:

  • diarrhea
  • nausea
  • abdominal pain or discomfort
  • eructation

Mechanism of Action

Epanova (omega-3-carboxylic acids) is a lipid-regulating agent containing fish oil-derived free fatty acids, designated omega-3-carboxylic acids, with at least 850 mg of polyunsaturated fatty acids, including multiple omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA]. The mechanism of action of Epanova is not completely understood. Potential mechanisms of action include inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase, increased mitochondrial and peroxisomal ß-oxidation in the liver, decreased lipogenesis in the liver, and increased plasma lipoprotein lipase activity. Epanova may reduce the synthesis of triglycerides in the liver because EPA and DHA are poor substrates for the enzymes responsible for TG synthesis, and EPA and DHA inhibit esterification of other fatty acids.

Additional Information

For additional information regarding Epanova or severe hypertriglyceridemia, please visit the Epanova web page.