Methods of treating mixed dyslipidemia

• US 10,624,870 B2
• Filed: 02/25/2019
• Issued: 04/21/2020
• Est. Priority Date: 04/29/2009
• Status: Active Grant

• Current Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Original Assignee: Amarin Pharmaceuticals Ireland Limited (Amarin Corporation plc)
• Inventors: Osterloh, Ian, Wicker, Pierre, Braeckman, Rene, Soni, Paresh, Manku, Mehar
• Primary Examiner(s): Weddington, Kevin E
• Application Number:
  US16/284,543
• Publication Number:
  US 20190183831A1
• Time in Patent Office: 421 Days
• Field of Search: 514558, 514559, 514560
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/202 having three or more double bonds, e.g. linolenic eicosanoids, e.g. leukotrienes A61K31/557
• CPC Class Codes: A61K 31/222 with compounds having aromatic groups, e.g. dipivefrine, ibopamine
• CPC Class Codes: A61K 31/232 having three or more double bonds, e.g. etretinate
• CPC Class Codes: A61K 31/40 having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/74 Synthetic polymeric materials
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/48 Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 : for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/18 : for HIV
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/12 : Antidiuretics, e.g. drugs for diabetes insipidus ADH A61P5/10
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 : Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 : Antiarrhythmics
• CPC Class Codes: A61P 9/10 : for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 : Antihypertensives

Abstract

The present disclosure relates to, inter alia, methods of treating cardiovascular-related disease.

Claims

1. A method of treating hypertriglyceridemia in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising eicosapentaenoic acid and docosapentaenoic acid, wherein the eicosapentaenoic acid is present in an amount of about 60% to about 90%, by weight, of all fatty acids present in the pharmaceutical composition and the docosapentaenoic acid is present in an amount of up to about 20%, by weight, of all fatty acids in the pharmaceutical composition, and wherein the pharmaceutical composition comprises substantially no or no docosahexaenoic acid.

2. The method of claim 1, wherein the eicosapentaenoic acid is present in an amount of about 70% to about 90%, by weight, of all fatty acids present in the pharmaceutical composition.

3. The method of claim 1, wherein the docosapentaenoic acid is present in an amount up to about 10%, by weight, of all fatty acids present in the pharmaceutical composition.

4. The method of claim 3, wherein the docosapentaenoic acid is present in an amount up to about 5%, by weight, of all fatty acids present in the pharmaceutical composition.

5. The method of claim 4, wherein the docosapentaenoic acid is present in an amount of about 5%, by weight, of all fatty acids present in the pharmaceutical composition.

6. The method of claim 1, wherein the pharmaceutical composition is encapsulated in a capsule shell.

7. The method of claim 1, wherein the pharmaceutical composition comprises eicosapentaenoic acid in an amount of about 750 mg to about 950 mg.

8. The method of claim 4, wherein the pharmaceutical composition is encapsulated in a capsule shell.

9. The method of claim 1, wherein the pharmaceutical composition comprises eicosapentaenoic acid in an amount of about 750 mg to about 950 mg.

10. The method of claim 4, wherein about 2 g to about 4 g of the pharmaceutical composition is administered to the subject per day.

11. A method of treating hypertriglyceridemia in a subject, comprising administering to the subject one to four capsules per day, each capsule comprising a pharmaceutical composition comprising docosapentaenoic acid in an amount of up to about 20%, by weight, of all fatty acids in the pharmaceutical composition and about 750 mg to about 950 mg eicosapentaenoic acid, and wherein the pharmaceutical composition comprises substantially no or no docosahexaenoic acid.