Claims for Patent: 10,117,844

Summary for Patent: 10,117,844

Title:	DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Abstract:	DPA-enriched pharmaceutical compositions of polyunsaturated fatty acids in free acid form, therapeutic methods for their use, and processes for refining the compositions from fish oil are presented.
Inventor(s):	Maines; Timothy J. (Potomac, MD), Machielse; Bernardus N. (North Potomac, MD), Mehta; Bharat M. (Mendham, NJ), Wisler; Gerald L. (Windermere, FL), Davidson; Michael H. (Highland Park, IL), Wood; Peter Ralph (Glen View, GB)
Assignee:	Omthera Pharmaceuticals, Inc. (Princeton, NJ) Chrysalis Pharma AG (CH)
Application Number:	14/699,556
Patent Claims:	1. A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition comprising: eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight; docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight; and docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight; wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form; and wherein the composition is not administered at the same time as a statin. 2. The method of claim 1, wherein at least 95% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form. 3. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 1.5%. 4. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 2%. 5. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 2.5%. 6. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 3%. 7. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 3.5%. 8. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 4%. 9. The method of claim 1, wherein DPA is present in the composition in a weight percent amount of at least 4.5%. 10. The method of claim 1, wherein the composition comprises a unit dose of at least 500 mg of the composition. 11. The method of claim 1, wherein the composition comprises a unit dose of about 1 gram of the composition. 12. The method of claim 1, comprising orally administering a dose of 2-4 grams per day of the composition. 13. The method of claim 12, wherein the dose is 2 grams per day. 14. The method of claim 1, further comprising orally administering to the patient a therapeutically effective amount of rosuvastatin, wherein the composition is not administered at the same time as the rosuvastatin. 15. The method of claim 1, wherein the patient is concurrently on statin therapy. 16. The method of claim 15, wherein the statin is selected from pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, rosuvastatin, tenivastatin, and pitavastatin. 17. The method of claim 15, wherein the statin is rosuvastatin. 18. The method of claim 1, comprising administering the composition for a duration effective to reduce serum or plasma triglycerides by at least about 5% below pre-treatment levels. 19. The method of claim 1, comprising administering the composition for a duration effective to reduce serum or plasma triglycerides by at least about 10% below pre-treatment levels. 20. The method of claim 12, wherein the dose is 4 grams per day. 21. A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition and a therapeutically effective amount of a statin; wherein the pharmaceutical composition comprises: eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight; docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight; and docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight; wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form; the statin is administered on a dosage schedule different from the pharmaceutical composition; and the method comprises administering a single statin. 22. The method of claim 21, wherein the statin is selected from pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, rosuvastatin, tenivastatin, and pitavastatin. 23. The method of claim 21, wherein the statin is rosuvastatin. 24. The method of claim 21, wherein the composition is not administered at the same time as a statin. 25. The method of claim 21, wherein at least 95% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form. 26. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 1.5%. 27. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 2%. 28. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 2.5%. 29. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 3%. 30. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 3.5%. 31. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 4%. 32. The method of claim 21, wherein DPA is present in the composition in a weight percent amount of at least 4.5%. 33. The method of claim 21, wherein the composition comprises a unit dose of at least 500 mg of the composition. 34. The method of claim 21, wherein the composition comprises a unit dose of about 1 gram of the composition. 35. The method of claim 21, comprising orally administering a dose of 2-4 grams per day of the composition. 36. The method of claim 35, wherein the dose is 2 grams per day. 37. The method of claim 35, wherein the dose is 4 grams per day. 38. The method of claim 21, comprising administering the composition for a duration effective to reduce serum or plasma triglycerides by at least about 5% below pre-treatment levels. 39. The method of claim 21, comprising administering the composition for a duration effective to reduce serum or plasma triglycerides by at least about 10% below pre-treatment levels. 40. A method of treating hypertriglyceridemia, comprising orally administering to a patient having pre-treatment serum or plasma triglyceride levels of about 200 mg/dL to about 500 mg/dL a therapeutically effective amount of a pharmaceutical composition comprising polyunsaturated fatty acids as the sole active pharmaceutical ingredient; wherein at least 90% by weight of the polyunsaturated fatty acid in the composition is present in the free acid form; and the polyunsaturated fatty acids comprise: eicosapentaenoic acid (EPA), in an amount of 50% to 60% by weight of the composition; docosahexaenoic acid (DHA), in an amount of 17% to 23% by weight of the composition; and docosapentaenoic acid (C22:5 n-3) (DPA), in an amount of 1% to 8% by weight of the composition. 41. The method of claim 40, wherein the polyunsaturated fatty acids further comprise: heneicosapentaenoic acid (C21:5 n-3); arachidonic acid (C20:4 n-6) (AA); eicosatetraenoic acid (C20:4 n-3); moroctic acid (C18:4 n-3); docosapentaenoic acid (C22:5 n-6); and linoleic acid (C18:2 n-6). 42. The method of claim 40, wherein the patient is concurrently on statin therapy with a statin selected from pravastatin, lovastatin, simvastatin, atorvastatin, fluvastatin, rosuvastatin, tenivastatin, and pitavastatin. 43. The method of claim 40, wherein the patient is concurrently on statin therapy with rosuvastatin.