Omega-3 pentaenoic acid compositions and methods of use

Abstract

Orally administrable composition comprising fatty acids, wherein at least 50% by weight of the fatty acids comprise omega-3-fatty acids, salts or derivatives thereof, wherein the omega-3 fatty acids comprise eicosapentaenoic acid (EPA; C20:5-n3), docosapentaenoic acid (DPA; C22:5-n3), and docosahexaenoic acid (DHA; C22:6-n3), wherein the ratio of DHA to EPA (DHA:EPA) is less than 1:20, and wherein the ratio of DHA to DPA (DHA:DPA) is less than 2:1 are provided. These compositions can be used for the treatment or prophylaxis of dyslipidemic, cardiovascular, CNS, inflammatory, and other diseases/conditions or risk factors therefore.

What is claimed is: 
     
         1 - 30 . (canceled) 
     
     
         31 . An orally administrable pharmaceutical composition comprising a capsule containing a capsule fill formulation comprising an omega-3 fatty acid composition, wherein the omega-3 fatty acid composition comprises 750-950 mg/g of eicosapentaenoic acid (EPA), 50-130 mg/g of docosapentaenoic acid (DPA), 5-70 mg/g of heneicosapentaenoic acid (HPA) and up to 40 mg/g of docosahexaenoic acid (DHA), based on the total weight of the capsule fill formulation and wherein the EPA, DPA, HPA and DHA are in free fatty acid form. 
     
     
         32 . The orally administrable pharmaceutical composition of  claim 31 , wherein 870-990 mg/g of the omega-3 fatty acid composition is contained in the capsule, based on the total weight of the capsule fill formulation. 
     
     
         33 . The orally administrable pharmaceutical composition of  claim 31 , wherein the omega-3 fatty acid composition comprises 800-950 mg/g of EPA, 60-100 mg/g of DPA, 5-60 mg/g of HPA and up to 25 mg/g of DHA, based on the total weight of the capsule fill formulation. 
     
     
         34 . The orally administrable pharmaceutical composition of  claim 33 , wherein 880-980 mg/g of the omega-3 fatty acid composition is contained in the capsule, based on the total weight of the capsule fill formulation. 
     
     
         35 . The orally administrable pharmaceutical composition of  claim 31 , wherein the total weight of the omega-3 fatty acid composition in the capsule is approximately 1 gram. 
     
     
         36 . The orally administrable pharmaceutical composition of  claim 31 , wherein the capsule comprises a softgel. 
     
     
         37 . The orally administrable pharmaceutical composition of  claim 31 , wherein the capsule fill formulation further comprises one or more chemical antioxidants. 
     
     
         38 . A pharmaceutical composition comprising eicosapentaenoic acid (EPA) in an amount between about 80% to about 90% of the total amount of fatty acids, docosapentaenoic acid (DPA) in an amount between about 5% to about 15% of the total amount of fatty acids, heneicosapentaenoic acid (HPA) in an amount of at least 1% of the total amount of fatty acids and no more than 5% of the total amount of fatty acids of docosahexaenoic acid (DHA). 
     
     
         39 . The pharmaceutical composition of  claim 38 , wherein the EPA is in an amount between about 82% to about 88% of the total amount of fatty acids. 
     
     
         40 . The pharmaceutical composition of  claim 38 , wherein the DPA is in an amount between about 6% to about 12% of the total amount of fatty acids. 
     
     
         41 . The pharmaceutical composition of  claim 38 , further comprising a capsule containing the pharmaceutical composition. 
     
     
         42 . The pharmaceutical composition of  claim 41 , wherein the capsule comprises a softgel. 
     
     
         43 . The pharmaceutical composition of  claim 38 , further comprising one or more chemical antioxidants. 
     
     
         44 . A method for reducing risk of cardiac and/or cardiovascular and/or vascular events comprising administering to a subject in need thereof the orally administrable pharmaceutical composition of  claim 31 . 
     
     
         45 . The method of  claim 44 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, ischemic cardiac attack, ischemic attack, acute angina, hospitalization due to acute angina, stroke, transient ischemic cerebral attack, cardiac revascularization, cardiac revascularization with stent placement, carotid artery revascularization, carotid artery revascularization with stent placement, peripheral artery revascularization, peripheral artery revascularization with stent placement, plaque rupture, death due to cardiovascular event, and hospitalization due to cardiovascular event. 
     
     
         46 . The method of  claim 44 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, angina, cardiac revascularization and stroke. 
     
     
         47 . The method of  claim 44 , wherein the subject is on concomitant treatment with a statin. 
     
     
         48 . The method of  claim 44 , wherein the subject is afflicted with vascular disease. 
     
     
         49 . The method of  claim 44 , wherein the method comprises administering 4 capsules per day. 
     
     
         50 . The method of  claim 44 , wherein the method comprises administering approximately 4 g of the omega-3 fatty acid composition per day. 
     
     
         51 . A method for reducing risk of cardiac and/or cardiovascular and/or vascular events comprising administering to a subject in need thereof the orally administrable pharmaceutical composition of  claim 33 . 
     
     
         52 . The method of  claim 51 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, ischemic cardiac attack, ischemic attack, acute angina, hospitalization due to acute angina, stroke, transient ischemic cerebral attack, cardiac revascularization, cardiac revascularization with stent placement, carotid artery revascularization, carotid artery revascularization with stent placement, peripheral artery revascularization, peripheral artery revascularization with stent placement, plaque rupture, death due to cardiovascular event, and hospitalization due to cardiovascular event. 
     
     
         53 . The method of  claim 51 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, angina, cardiac revascularization and stroke. 
     
     
         54 . The method of  claim 51 , wherein the subject is on concomitant treatment with a statin. 
     
     
         55 . The method of  claim 51 , wherein the subject is afflicted with vascular disease. 
     
     
         56 . The method of  claim 51 , wherein the method comprises administering 4 capsules per day. 
     
     
         57 . The method of  claim 51 , wherein the method comprises administering approximately 4 g of the omega-3 fatty acid composition per day. 
     
     
         58 . A method for reducing risk of cardiac and/or cardiovascular and/or vascular events comprising administering to a subject in need thereof the pharmaceutical composition of  claim 38 . 
     
     
         59 . The method of  claim 58 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, ischemic cardiac attack, ischemic attack, acute angina, hospitalization due to acute angina, stroke, transient ischemic cerebral attack, cardiac revascularization, cardiac revascularization with stent placement, carotid artery revascularization, carotid artery revascularization with stent placement, peripheral artery revascularization, peripheral artery revascularization with stent placement, plaque rupture, death due to cardiovascular event, and hospitalization due to cardiovascular event. 
     
     
         60 . The method of  claim 58 , wherein the cardiac and/or cardiovascular and/or vascular event is one or more events selected from the group consisting of myocardial infarction, angina, cardiac revascularization and stroke. 
     
     
         61 . The method of  claim 58 , wherein the subject is on concomitant treatment with a statin. 
     
     
         62 . The method of  claim 58 , wherein the subject is afflicted with vascular disease. 
     
     
         63 . The method of  claim 58 , wherein the pharmaceutical composition further comprises a capsule containing the pharmaceutical composition and the method comprises administering 4 capsules per day. 
     
     
         64 . The method of  claim 58 , wherein the method comprises administering approximately 4 g of the pharmaceutical composition per day.