Omega-3 pentaenoic acid compositions and methods of use

Abstract

Orally administrable composition comprising fatty acids comprising omega-3-fatty acids, salts or derivatives thereof 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: 
     
         1 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising fatty acids, wherein at least 50% by weight of the fatty acids comprise omega-3 fatty acids, salts, esters, or derivatives thereof, wherein the omega-3 fatty acids comprise eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) and wherein the ratio of docosahexaenoic acid to DHA to EPA (DHA:EPA) is less than 1:10, and wherein the ratio of DHA to DPA (DHA:DPA) is less than 2:1. 
     
     
         2 . The method of  claim 1 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         3 . The method of  claim 1 , wherein the ratio of DHA:EPA is less than 1:20. 
     
     
         4 . The method of  claim 1 , wherein the ratio of DHA:DPA is less than 1:1. 
     
     
         5 . The method of  claim 1 , wherein the ratio of EPA to DPA (EPA:DPA) is between 30:1 and 1:1. 
     
     
         6 . The method of  claim 1 , wherein ratio of DHA:EPA is less than 1:10. 
     
     
         7 . The method of  claim 1 , wherein the composition comprises DHA in an amount less than 5% of the total amount of fatty acids. 
     
     
         8 . The method of  claim 1 , wherein the composition comprises EPA in an amount between about 80% and about 90% of the total amount of fatty acids. 
     
     
         9 . The method of  claim 1 , wherein the composition comprises DPA in an amount between about 5% and about 15% of the total amount of fatty acids. 
     
     
         10 . The method of  claim 1 , wherein the composition comprises DPA free fatty acid or a salt, ester or derivative of DPA. 
     
     
         11 . The method of  claim 1 , wherein composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         12 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) in an amount between about 750 mg/g to about 950 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         13 . The method of  claim 12 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         14 . The method of  claim 12 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 800 mg/g to about 900 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         15 . The method of  claim 12 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 830 mg/g to about 870 mg/g,
 and wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and   and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         16 . The method of  claim 12 , wherein the composition comprises docosapentaenoic acid (DPA) is an amount between about 60 mg/g to about 120 mg/g. 
     
     
         17 . The method of  claim 1 , wherein the composition comprises docosapentaenoic acid (DPA) is an amount between about 70 mg/g to about 100 mg/g. 
     
     
         18 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising:
 eicosapentaenoic acid (EPA) in an amount between about 70% to about 95% of the total amount of fatty acids and   docosapentaenoic acid (DPA),   wherein the composition comprises no more than 5% docosahexaenoic acid (DHA) of the total amount of fatty acids, and   wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         19 . The method of  claim 18 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         20 . The method of  claim 18 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 80% to about 90% of the total amount of fatty acids. 
     
     
         21 . The method of  18 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount between about 82% to about 88% of the total amount of fatty acids. 
     
     
         22 . The method of  18 , wherein the composition comprises docosapentaenoic acid (DPA) in amount between about 5% and about 15% of the total amount of fatty acids. 
     
     
         23 . The method of  18 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 6% to about 12% of the total amount of fatty acids. 
     
     
         24 . The method of  claim 18 , wherein the composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         25 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) in a daily dosage amount of between about 1000 mg to about 5000 mg,
 and further comprising docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA),   wherein the composition comprises no more than 5% DHA of the total amount of fatty acids, and wherein the ratio of DHA:DPA is 1:1 or lower.   
     
     
         26 . The method of  claim 25 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         27 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in a daily dosage amount selected from the group consisting of: about 1735 mg to about 1855 mg, about 2520 mg to about 2780 mg, and about 3360 mg to about 3710 mg. 
     
     
         28 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in a daily dosage amount selected from the group consisting of: about 1750 mg to about 1950 mg, about 1800 mg to about 2000 mg about 2650 mg to about 2950 mg, and about 3500 mg to about 3900 mg. 
     
     
         29 . The method of  claim 25 , wherein the composition comprises eicosapentaenoic acid (EPA) in daily dosage amount selected from the group consisting of: about 1900 mg to about 2100 mg, about 2700 mg to about 3300 mg, and about 3700 mg to about 4300 mg. 
     
     
         30 . The method of  claim 25 , wherein the composition comprises EPA free fatty acid or a salt, ester or derivative of EPA. 
     
     
         31 . The method of  claim 25 , wherein the composition comprises DPA free fatty acid or a salt, ester or derivative of DPA. 
     
     
         32 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA), wherein the amount of EPA and DPA is about 55% or more by weight of the total amount of fatty acids, and wherein the ratio of DHA:DPA is no more than 1:1. 
     
     
         33 . The method of  claim 32 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         34 . The method of  claim 32 , wherein the composition comprises a daily dosage of about 120 mg/day to about 150 mg/day. 
     
     
         35 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 150 mg/day to about 200 mg/day. 
     
     
         36 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 200 mg/day to about 250 mg/day. 
     
     
         37 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 250 mg/day to about 300 mg/day. 
     
     
         38 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 300 mg/day to about 400 mg/day. 
     
     
         39 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 400 mg/day to about 600 mg/day. 
     
     
         40 . The method of  claim 32 , wherein the composition comprises a daily dosage of DPA of about 600 mg/day to about 1000 mg/day. 
     
     
         41 . The method of  claim 32 , wherein the composition further comprises eicosapentaenoic acid (EPA) and, wherein the amount of EPA and DPA is about 55% or more by weight of the total amount of fatty acids, and wherein the ratio of DHA:DPA is no more than 1:1. 
     
     
         42 . The method of  claim 32 , wherein the amount of EPA and DPA is selected from the group consisting of about 60% or more, about 65% or more, about 70% or more, about 75% or more, about 80% or more, about 85% or more, and about 90% or more by weight of the total amount of fatty acids. 
     
     
         43 . The method of  claim 32 , wherein the composition comprises further omega-6 fatty acids in an amount of no more than 6% of total amount of fatty acids. 
     
     
         44 . The method of  claim 32 , wherein the composition comprises no more than about 30% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         45 . The method of  claim 32 , wherein the composition comprises no more than about 10% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         46 . The method of  claim 32 , wherein the composition comprises no more than about 5% docosahexaenoic acid (DHA) by weight of fatty acids present in the composition. 
     
     
         47 . The method of  claim 32 , wherein the composition comprises DPA in ethyl ester form. 
     
     
         48 . The method of  claim 32 , wherein the composition comprises DPA in free fatty acid form. 
     
     
         49 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 2:1. 
     
     
         50 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:1. 
     
     
         51 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:2. 
     
     
         52 . The method of  claim 32 , wherein the composition further comprises docosahexaenoic acid (DHA), and the ratio of DHA:DPA is no more than 1:4. 
     
     
         53 . The method of  claim 32 , wherein the composition comprises at least about 6% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         54 . The method of  claim 32 , wherein the composition comprises at least about 20% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         55 . The method of  claim 32 , wherein the composition comprises at least about 50% docosapentaenoic acid (DPA) by weight of fatty acids present in the composition. 
     
     
         56 . A method of treating, preventing, reducing the occurrence of, and improving symptoms associated with an inflammatory disease or condition in a subject in need thereof, comprising administering to the subject a composition comprising: docosapentaenoic acid (DPA) in an amount between about 50% to about 80% of the total amount of fatty acids, docosahexaenoic acid (DHA) in an amount between about 25% to about 40% of the total amount of fatty acids, and optionally eicosapentaenoic acid (EPA) in an amount less than about 10% of the total amount of fatty acids. 
     
     
         57 . The method of  claim 56 , wherein the inflammatory disease or condition is selected from the group consisting of: primary dysmenorrhea, secondary dysmenorrhea, osteoarthritis, rheumatoid arthritis, asthma, chronic obstructive pulmonary disease (COPD), ulcerative colitis, psoriasis, irritable bowel syndrome, dry eye, allergic ocular reactions, post-surgical pain, post-trauma pain due to strains, sprains and tears of the musculoskeletal system, connective tissue disorders including Raynaud's disease and fibromyalgia, mittlesmerchz (pain associated with ovulation), premature (preterm) labor, endometriosis, and polycystic ovarian syndrome (PCOS), diabetes, atherosclerosis, renal failure, kidney stones, toxemia, leukemia, encephalitis, respiratory syncytial virus, meningitis, Alzheimer's Disease, herpes simplex virus and sequalae, neuropathic pain, solid tumors, enlarged prostate, macular degeneration, and lupus. 
     
     
         58 . The method of  claim 56 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 50% to 75% of the total amount of fatty acids. 
     
     
         59 . The method of  claim 56 , wherein the composition comprises docosapentaenoic acid (DPA) in an amount between about 50% to 65% of the total amount of fatty acids. 
     
     
         60 . The method of  claim 56 , wherein the composition comprises docosahexaenoic acid (DHA) in an amount between about 25% to about 35%, of the total amount of fatty acids. 
     
     
         61 . The method of  claim 56 , wherein the composition comprises docosahexaenoic acid (DHA) in an amount between about 30% to about 35% of the total amount of fatty acids. 
     
     
         62 . The method of  claim 56 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount less than about 8% of the total amount of fatty acids. 
     
     
         63 . The method of  claim 56 , wherein the composition comprises eicosapentaenoic acid (EPA) in an amount less than about 5% of the total amount of fatty acids.