# US 9,433,612 B2 · Methods for treating hyperuricemia in patients with gout using halofenate or halofenic acid and a second urate-lowering agent > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,612 B2 - Document ID: US9433612B2 - Status: Granted - Kind: B2 - Application number: 14/703,660 - Filed: 2015-05-04 - Published: 2016-02-25 - Granted: 2016-09-06 - Earliest claimed: 2011-11-04 - Assignees: CymaBay Therapeutics, Inc.; DiaTex, Inc. - Applicants: CymaBay Therapeutics, Inc. - Inventors: Brian K. Roberts; Gopal Chandra Saha; Brian Edward Lavan; Charles A. McWherter - Web page: https://patentgrep.com/patent/US9433612B2 ## CPC - A61K 31/426: 1,3-Thiazoles - A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)} - A61K 9/10: Dispersions; Emulsions - A61K 9/20: Pills, tablets, {discs, rods (A61K9/0004, A61K9/0007, A61K9/0056, A61K9/0065 take precedence; for reconstitution of a drink A61K9/0095)} - A61K 9/48: Preparations in capsules, e.g. of gelatin, of chocolate {(A61K9/0004 takes precedence; bite capsules A61K9/0056)} - A61K 31/192: having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid {(cannabinoids A61K31/658)} - A61K 31/216: of acids having aromatic rings, e.g. benactizyne, clofibrate - A61K 31/222: with compounds having aromatic groups, e.g. dipivefrine, ibopamine - A61K 31/519: ortho- or peri-condensed with heterocyclic rings - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract Disclosed herein are pharmaceutical compositions, methods and kits for lowering the serum uric acid level of a subject and for the treatment of a condition associated with elevated serum uric acid levels comprising administering a composition comprising a first urate-lowering agent and a second urate-lowering agent. In some aspects the first urate-lowering agent is (−)-halofenate, (−)-halofenic acid, or a pharmaceutically acceptable salts thereof. In some aspects the second urate-lowering agent is an inhibitor of uric acid production, a uricosuric agent, a uricase, or a pharmaceutically acceptable salt thereof. ## Claims ### Claim 1 An oral dosage composition comprising a therapeutically effective amount of: (a) a first urate-lowering agent that is (−)-halofenate, or (−)-halofenic acid or a pharmaceutically acceptable salt thereof, substantially free from its (+)-enantiomer; and (b) a second urate-lowering agent that is febuxostat. ### Claim 2 (depends on 1) The composition of claim 1, where the first urate-lowering agent is (−)-halofenate. ### Claim 3 (depends on 2) The composition of claim 2, where the amount of the (−)-halofenate is between about 100 mg and about 1000 mg. ### Claim 4 (depends on 3) The composition of claim 3, where the amount of the (−)-halofenate is between about 400 mg and about 800 mg. ### Claim 5 (depends on 2) The composition of claim 2, where the amount of the febuxostat is between about 10 mg and about 240 mg. ### Claim 6 (depends on 5) The composition of claim 5, where the amount of the febuxostat is between about 40 mg and about 120 mg. ### Claim 7 (depends on 4) The composition of claim 4, where the amount of the (−)-halofenate is between about 400 mg and about 800 mg and the amount of the febuxostat is between about 40 mg and about 120 mg. ### Claim 8 (depends on 2) The composition of claim 2, where the amounts of the (−)-halofenate and the febuxostat are therapeutically effective for once/day dosing. ### Claim 9 (depends on 2) The composition of claim 2 that is a tablet. ### Claim 10 (depends on 2) The composition of claim 2 that is a capsule. ### Claim 11 (depends on 2) The composition of claim 2 that is a syrup. ### Claim 12 (depends on 2) The composition of claim 2 that is a suspension. ### Claim 13 (depends on 1) The composition of claim 1, where the first urate-lowering agent is (−)-halofenic acid or a pharmaceutically acceptable salt thereof. ### Claim 14 (depends on 13) The composition of claim 13, where the amount of the (−)-halofenic acid or a pharmaceutically acceptable salt thereof is between about 100 mg and about 1000 mg. ### Claim 15 (depends on 14) The composition of claim 14, where the amount of the (−)-halofenic acid or a pharmaceutically acceptable salt thereof is between about 400 mg and about 800 mg. ### Claim 16 (depends on 13) The composition of claim 13, where the amount of the febuxostat is between about 10 mg and about 240 mg. ### Claim 17 (depends on 16) The composition of claim 16, where the amount of the febuxostat is between about 40 mg and about 120 mg. ### Claim 18 (depends on 14) The composition of claim 14, where the amount of the (−)-halofenic acid or a pharmaceutically acceptable salt thereof is between about 400 mg and about 800 mg and the amount of the febuxostat is between about 40 mg and about 120 mg. ### Claim 19 (depends on 13) The composition of claim 13, where the amounts of the (−)-halofenic acid or a pharmaceutically acceptable salt thereof and the febuxostat are therapeutically effective for once/day dosing. ### Claim 20 (depends on 13) The composition of claim 13 that is a tablet. ### Claim 21 (depends on 13) The composition of claim 13 that is a capsule. ### Claim 22 (depends on 13) The composition of claim 13 that is a syrup. ### Claim 23 (depends on 13) The composition of claim 13 that is a suspension.