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AssigneeArena Pharmaceuticals, Inc.
InventorsCheryl Geraldine Lassen, Robert Mark Jones, Que Liu, Ronald J. Christopher
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The present invention relates to, inter alia, methods of treatment and combinations of (R)-2-(7-(4-cyclopentyl-3-(tri-fluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid (Compound 1) useful for the treatment of primary biliary cholangitis (PBC). In some embodiments, the methods further comprise administering Compound 1, or a pharmaceutically salt, solvate, or hydrate thereof, in combination with a compound selected from the group consisting of: an antihistamine (diphenhydramine), cholestyramine (questran, prevalite), rifampin, an opioid antagonist (naloxone), pilocarpine (isopto carpine, salagen), cevimeline (evoxac), calcium and/or vitamin D supplement, and vitamin A, D, E and/or K supplement. Other embodiments, relate to titration packages for enabling compliance with a regimen of changing dosage of a medication over a period of time for the treatment of primary biliary cholangitis (PBC).
A method of treating primary biliary cholangitis (PBC) in an individual in need thereof comprising administering a therapeutically effective amount of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta[b]indol-3-acetic acid (Compound 1), or a pharmaceutically salt, solvate, or hydrate thereof, wherein the individual is currently treated with a therapeutically effective amount of ursodeoxycholic acid (UDCA), wherein Compound 1 is administered without food.
A method of treating fatigue, pruritus, eye dryness, and/or Sjögren's syndrome (SS) in an individual with primary biliary cholangitis (PBC) comprising administering a therapeutically effective amount of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta[b]indol-3-acetic acid (Compound 1), or a pharmaceutically salt, solvate, or hydrate thereof,
Dependencies are inferred from the claim text.