Details for Patent: 9,072,715
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Title: | Stable pharmaceutical composition and methods of using same |
Abstract: | The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases. |
Inventor(s): | Manku; Mehar (Birmingham, GB), Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT) |
Assignee: | Amarin Pharmaceuticals Ireland Limited (Dublin, IE) |
Filing Date: | Apr 23, 2014 |
Application Number: | 14/259,724 |
Claims: | 1. A method of lowering non-HDL-C in a subject having triglycerides of 200 mg/dl or greater who is receiving statin therapy comprising, administering to the subject daily for a period effective to reduce non-HDL-C in the subject a pharmaceutical composition comprising: an amount of eicosapentaenoic acid selected from the group consisting of about 1100 mg, about 1650 mg and about 2200 mg; and docosahexaenoic acid in an amount up to about 20%, by weight of fatty acids present, and docosapentaenoic acid in an amount up to about 10% by weight of fatty acids present. 2. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 3% in the subject. 3. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce non-HDL-C by at least about 5% in the subject. 4. The method of claim 2 wherein the reduction is relative to placebo control. 5. The method of claim 3 wherein the reduction is relative to placebo control. 6. The method of claim 2 wherein the reduction is relative to a baseline non-HDL-C level in the subject. 7. The method of claim 3 wherein the reduction is relative to a baseline non-HDL-C level in the subject. 8. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to decrease triglycerides in the subject. 9. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to increase HDL-C in the subject. 10. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject. 11. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1100 mg. 12. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 1650 mg. 13. The method of claim 1 wherein the eicosapentaenoic acid is present in an amount of about 2200 mg. 14. The method of claim 1 wherein the pharmaceutical composition comprises less than about 20% docosahexaenoic acid, by weight of total fatty acids. 15. The method of claim 1 wherein the period is at least about 12 weeks. 16. The method of claim 1 wherein the composition is administered to the subject in one or more dosage units per day. |