Claims for Patent: 10,010,517

Summary for Patent: 10,010,517

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)
Application Number:	15/415,468
Patent Claims:	1. A method of lowering triglycerides in a subject having triglycerides of about 200 mg/dl to less than 500 mg/dl who is receiving statin therapy comprising, administering from 2000 mg to about 5000 mg to the subject daily a pharmaceutical composition comprising at least 96% pure ethyl-EPA for a period of at least about 4 weeks, and wherein the period is effective to lower fasting triglycerides in the subject compared to a fasting triglyceride level in a subject maintained on stable statin therapy without concomitant ethyl-EPA for said period. 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 increase HDL-C in the subject. 9. The method of claim 1 comprising, administering to the subject the pharmaceutical composition for a period effective to reduce total cholesterol in the subject. 10. The method of claim 1 wherein the pharmaceutical composition comprises less than about 20% docosahexaenoic acid, by weight of total fatty acids. 11. The method of claim 1 wherein the period is at least about 12 weeks. 12. The method of claim 1 wherein the composition is administered to the subject in one or more dosage units per day.