IP Library Granted Patent US 10,351,573
Granted Patent B2
US 10,351,573 · App. 15/487,757 · Granted Jul 16, 2019

Benzoic acid, benzoic acid derivatives and heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods of making and uses thereof

Inventors: Travis Mickle (Kissimmee, FL); Sven Guenther (Coralville, IA); Christal Mickle (Kissimmee, FL); Guochen Chi (Coralville, IA); Jaroslaw Kanski (Blacksburg, VA); Andrea K. Martin (Fincastle, VA); Bindu Bera (Blacksburg, VA)
Assignee: KemPharm, Inc.
C07D489/02A61K9/0019A61K9/20A61K9/2054A61K31/167A61K31/485A61K45/06A61K47/542A61K47/545A61K47/55A61K47/556A61P25/30C07D489/04C07D491/08
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Quick Facts
Patent No.
US 10,351,573
App. No.
15/487,757
Granted
Jul 16, 2019
Kind
B2
Abstract

The presently described technology provides compositions comprising aryl carboxylic acids chemically conjugated to hydrocodone (morphinan-6-one, 4,5-alpha-epoxy-3-methoxy-17-methyl) to form novel prodrugs/compositions of hydrocodone, including benzoates and heteroaryl carboxylic acids, which have a decreased potential for abuse of hydrocodone. The present technology also provides methods of treating patients, pharmaceutical kits and methods of synthesizing conjugates of the present technology.

Claims (80)

1. A compound having the following chemical structure:

or a salt thereof.

2. The compound of claim 1 , wherein the salt of the compound is a pharmaceutically acceptable salt.

3. The compound of claim 2 , wherein the salt is selected from the group consisting of acetate, L-aspartate, besylate, bicarbonate, carbonate, D-camsylate, L-camsylate, citrate, edisylate, fumarate, gluconate, hydrobromide, bromide, hydrochloride, chloride, D-lactate, L-lactate, D,L-lactate, D,L-malate, L-malate, mesylate, pamoate, phosphate, succinate, sulfate, D-tartrate, L-tartrate, D,L-tartrate, meso-tartrate, benzoate, gluceptate, D-glucuronate, hybenzate, isethionate, malonate, methylsulfate, 2-napsylate, nicotinate, nitrate, orotate, stearate, tosylate, acefyllinate, aceturate, aminosalicylate, ascorbate, borate, butyrate, camphorate, camphocarbonate, decanoate, hexanoate, cholate, cypionate, dichloroacetate, edentate, ethyl sulfate, furate, fusidate, galactarate, galacturonate, gallate, gentisate, glutamate, glutarate, glycerophosphate, heptanoate, hydroxybenzoate, hippurate, phenylpropionate, iodide, xinafoate, lactobionate, laurate, maleate, mandelate, methanesulfonate, myristate, napadisilate, oleate, oxalate, palmitate, picrate, pivalate, propionate, pyrophosphate, salicylate, salicylsulfate, sulfosalicylate, tannate, terephthalate, thiosalicylate, tribrophenate, valerate, valproate, adipate, 4-acetamidobenzoate, camsylate, octanoate, estolate, esylate, glycolate, thiocyanate, and undecylenate.

4. A compound having the following chemical structure:

or a salt thereof.

5. The compound of claim 4 , wherein the salt of the compound is a pharmaceutically acceptable salt.

6. The compound of claim 5 , wherein the salt is selected from the group consisting of acetate, L-aspartate, besylate, bicarbonate, carbonate, D-camsylate, L-camsylate, citrate, edisylate, fumarate, gluconate, hydrobromide, bromide, hydrochloride, chloride, D-lactate, L-lactate, D,L-lactate, D,L-malate, L-malate, mesylate, pamoate, phosphate, succinate, sulfate, D-tartrate, L-tartrate, D,L-tartrate, meso-tartrate, benzoate, gluceptate, D-glucuronate, hybenzate, isethionate, malonate, methylsulfate, 2-napsylate, nicotinate, nitrate, orotate, stearate, tosylate, acefyllinate, aceturate, aminosalicylate, ascorbate, borate, butyrate, camphorate, camphocarbonate, decanoate, hexanoate, cholate, cypionate, dichloroacetate, edentate, ethyl sulfate, furate, fusidate, galactarate, galacturonate, gallate, gentisate, glutamate, glutarate, glycerophosphate, heptanoate, hydroxybenzoate, hippurate, phenylpropionate, iodide, xinafoate, lactobionate, laurate, maleate, mandelate, methanesulfonate, myristate, napadisilate, oleate, oxalate, palmitate, picrate, pivalate, propionate, pyrophosphate, salicylate, salicylsulfate, sulfosalicylate, tannate, terephthalate, thiosalicylate, tribrophenate, valerate, valproate, adipate, 4-acetamidobenzoate, camsylate, octanoate, estolate, esylate, glycolate, thiocyanate, and undecylenate.

7. A compound having the following chemical structure:

or a salt thereof.

8. The compound of claim 7 , wherein the salt of the compound is a pharmaceutically acceptable salt.

9. The compound of claim 8 , wherein the salt is selected from the group consisting of acetate, L-aspartate, besylate, bicarbonate, carbonate, D-camsylate, L-camsylate, citrate, edisylate, fumarate, gluconate, hydrobromide, bromide, hydrochloride, chloride, D-lactate, L-lactate, D,L-lactate, D,L-malate, L-malate, mesylate, pamoate, phosphate, succinate, sulfate, D-tartrate, L-tartrate, D,L-tartrate, meso-tartrate, benzoate, gluceptate, D-glucuronate, hybenzate, isethionate, malonate, methylsulfate, 2-napsylate, nicotinate, nitrate, orotate, stearate, tosylate, acefyllinate, aceturate, aminosalicylate, ascorbate, borate, butyrate, camphorate, camphocarbonate, decanoate, hexanoate, cholate, cypionate, dichloroacetate, edentate, ethyl sulfate, furate, fusidate, galactarate, galacturonate, gallate, gentisate, glutamate, glutarate, glycerophosphate, heptanoate, hydroxybenzoate, hippurate, phenylpropionate, iodide, xinafoate, lactobionate, laurate, maleate, mandelate, methanesulfonate, myristate, napadisilate, oleate, oxalate, palmitate, picrate, pivalate, propionate, pyrophosphate, salicylate, salicylsulfate, sulfosalicylate, tannate, terephthalate, thiosalicylate, tribrophenate, valerate, valproate, adipate, 4-acetamidobenzoate, camsylate, octanoate, estolate, esylate, glycolate, thiocyanate, and undecylenate.

10. A compound having the following chemical structure:

or a salt thereof.

11. The compound of claim 10 wherein the salt of the compound is a pharmaceutically acceptable salt.

12. The compound of claim 11 , wherein the salt is selected from the group consisting of acetate, L-aspartate, besylate, bicarbonate, carbonate, D-camsylate, L-camsylate, citrate, edisylate, fumarate, gluconate, hydrobromide, bromide, hydrochloride, chloride, D-lactate, L-lactate, D,L-lactate, D,L-malate, L-malate, mesylate, pamoate, phosphate, succinate, sulfate, D-tartrate, L-tartrate, D,L-tartrate, meso-tartrate, benzoate, gluceptate, D-glucuronate, hybenzate, isethionate, malonate, methylsulfate, 2-napsylate, nicotinate, nitrate, orotate, stearate, tosylate, acefyllinate, aceturate, aminosalicylate, ascorbate, borate, butyrate, camphorate, camphocarbonate, decanoate, hexanoate, cholate, cypionate, dichloroacetate, edentate, ethyl sulfate, furate, fusidate, galactarate, galacturonate, gallate, gentisate, glutamate, glutarate, glycerophosphate, heptanoate, hydroxybenzoate, hippurate, phenylpropionate, iodide, xinafoate, lactobionate, laurate, maleate, mandelate, methanesulfonate, myristate, napadisilate, oleate, oxalate, palmitate, picrate, pivalate, propionate, pyrophosphate, salicylate, salicylsulfate, sulfosalicylate, tannate, terephthalate, thiosalicylate, tribrophenate, valerate, valproate, adipate, 4-acetamidobenzoate, camsylate, octanoate, estolate, esylate, glycolate, thiocyanate, and undecylenate.

13. A compound having the following chemical structure:

or a salt thereof.

14. The compound of claim 13 , wherein the salt of the compound is a pharmaceutically acceptable salt.

15. The compound of claim 14 , wherein the salt is selected from the group consisting of acetate, L-aspartate, besylate, bicarbonate, carbonate, D-camsylate, L-camsylate, citrate, edisylate, fumarate, gluconate, hydrobromide, bromide, hydrochloride, chloride, D-lactate, L-lactate, D,L-lactate, D,L-malate, L-malate, mesylate, pamoate, phosphate, succinate, sulfate, D-tartrate, L-tartrate, D,L-tartrate, meso-tartrate, benzoate, gluceptate, D-glucuronate, hybenzate, isethionate, malonate, methylsulfate, 2-napsylate, nicotinate, nitrate, orotate, stearate, tosylate, acefyllinate, aceturate, aminosalicylate, ascorbate, borate, butyrate, camphorate, camphocarbonate, decanoate, hexanoate, cholate, cypionate, dichloroacetate, edentate, ethyl sulfate, furate, fusidate, galactarate, galacturonate, gallate, gentisate, glutamate, glutarate, glycerophosphate, heptanoate, hydroxybenzoate, hippurate, phenylpropionate, iodide, xinafoate, lactobionate, laurate, maleate, mandelate, methanesulfonate, myristate, napadisilate, oleate, oxalate, palmitate, picrate, pivalate, propionate, pyrophosphate, salicylate, salicylsulfate, sulfosalicylate, tannate, terephthalate, thiosalicylate, tribrophenate, valerate, valproate, adipate, 4-acetamidobenzoate, camsylate, octanoate, estolate, esylate, glycolate, thiocyanate, and undecylenate.

16. A pharmaceutical kit comprising:

a specified amount of individual doses, wherein each individual dose comprises a pharmaceutically effective amount of at least one compound, or a pharmaceutically acceptable salt thereof, having the following chemical structure:

and instructions for use.

17. The pharmaceutical kit of claim 16 , wherein the instructions for use comprise a method for treating or preventing drug withdrawal symptoms in a human or animal patient.

18. The pharmaceutical kit of claim 16 , wherein the instructions for use comprise a method for treating pain in a human or animal patient.

19. The pharmaceutical kit of claim 16 , wherein the individual dose further comprises at least one carrier.

20. The pharmaceutical kit of claim 19 , wherein the at least one carrier is at least one biologically acceptable carrier.

21. The pharmaceutical kit of claim 20 , wherein the individual dose comprises at least about 0.5 mg to about 100 mg of the at least one compound.

22. The pharmaceutical kit of claim 20 , wherein the individual dose comprises at least about 5 mg to about 10 mg of the at least one compound.

23. The pharmaceutical kit of claim 20 , wherein the kit comprises from about 1 to about 60 individual doses.

24. The pharmaceutical kit of claim 20 , wherein the kit comprises from about 10 to about 30 individual doses.

25. The pharmaceutical kit of claim 20 , wherein the kit comprises from about 12 to about 28 individual doses.

26. A pharmaceutical kit comprising:

a specified amount of individual doses, wherein each individual dose comprises a pharmaceutically effective amount of at least one compound, or a pharmaceutically acceptable salt thereof, having the following chemical structure:

and instructions for use.

27. The kit of claim 26 , wherein the instructions for use comprise a method for treating or preventing drug withdrawal symptoms in a human or animal patient.

28. The kit of claim 26 , wherein the instructions for use comprise a method for treating pain in a human or animal patient.

29. The kit of claim 26 , wherein the individual dose further comprises at least one carrier.

30. The kit of claim 29 , wherein the at least one carrier is at least one biologically acceptable carrier.

31. The kit of claim 30 , wherein the individual dose comprises at least about 0.5 mg to about 100 mg of the at least one compound.

32. The kit of claim 30 , wherein the individual dose comprises at least about 5 mg to about 10 mg of the at least one compound.

33. The kit of claim 30 , wherein the kit further comprises from about 1 to about 60 individual doses.

34. The kit of claim 30 , wherein the kit comprises from about 10 to about 30 individual doses.

35. The kit of claim 30 , wherein the kit further comprises from about 12 to about 28 individual doses.

36. A pharmaceutical kit comprising:

a specified amount of individual doses, wherein each individual dose comprises a pharmaceutically effective amount of at least one compound, or a pharmaceutically acceptable salt thereof, having the following chemical structure:

and instructions for use.

37. The pharmaceutical kit of claim 36 , wherein the instructions for use comprise a method for treating or preventing drug withdrawal symptoms in a human or animal patient.

38. The pharmaceutical kit of claim 36 , wherein the instructions for use comprise a method for treating pain in a human or animal patient.

39. The pharmaceutical kit of claim 36 , wherein the individual dose further comprises at least one carrier.

40. The pharmaceutical kit of claim 39 , wherein the at least one carrier is at least one biologically acceptable carrier.

41. The pharmaceutical kit of claim 40 , wherein the individual dose comprises at least about 0.5 mg to about 100 mg of the at least one compound.

42. The pharmaceutical kit of claim 40 , wherein the individual dose comprises at least about 5 mg to about 10 mg of the at least one compound.

43. The pharmaceutical kit of claim 40 , wherein the kit further comprises from about 1 to about 60 individual doses.

44. The pharmaceutical kit of claim 40 , wherein the kit comprises from about 10 to about 30 individual doses.

45. The pharmaceutical kit of claim 40 , wherein the kit further comprises from about 12 to about 28 individual doses.

46. A pharmaceutical kit comprising:

a specified amount of individual doses, wherein each individual dose comprises a pharmaceutically effective amount of at least one compound, or a pharmaceutically acceptable salt thereof, having the following chemical structure:

and instructions for use.

47. The pharmaceutical kit of claim 46 , wherein the instructions for use comprise a method for treating or preventing drug withdrawal symptoms in a human or animal patient.

48. The pharmaceutical kit of claim 46 , wherein the instructions for use comprise a method for treating pain in a human or animal patient.

49. The pharmaceutical kit of claim 46 , wherein the individual dose further comprises at least one carrier.

50. The pharmaceutical kit of claim 49 , wherein the at least one carrier is at least one biologically acceptable carrier.

51. The pharmaceutical kit of claim 50 , wherein the individual dose comprises at least about 0.5 mg to about 100 mg of the at least one compound.

52. The pharmaceutical kit of claim 50 , wherein the individual dose comprises at least about 5 mg to about 10 mg of the at least one compound.

53. The pharmaceutical kit of claim 50 , wherein the kit further comprises from about 1 to about 60 individual doses.

54. The pharmaceutical kit of claim 50 , wherein the kit comprises from about 10 to about 30 individual doses.

55. The pharmaceutical kit of claim 50 , wherein the kit further comprises from about 12 to about 28 individual doses.

56. A pharmaceutical kit comprising:

a specified amount of individual doses, wherein each individual does comprises a pharmaceutically effective amount of at least one compound, or a pharmaceutically acceptable salt thereof, having the following chemical structure:

and instructions for use.

57. The pharmaceutical kit of claim 56 , wherein the instructions for use comprise a method for treating or preventing drug withdrawal symptoms in a human or animal patient.

58. The pharmaceutical kit of claim 56 , wherein the instructions for use comprise a method for treating pain in a human or animal patient.

59. The pharmaceutical kit of claim 56 , wherein the individual dose further comprises at least one carrier.

60. The pharmaceutical kit of claim 59 , wherein the at least one carrier is at least one biologically acceptable carrier.

61. The pharmaceutical kit of claim 60 , wherein the individual dose comprises at least about 0.5 mg to about 100 mg of the at least one compound.

62. The kit of claim 60 , wherein the individual dose comprises at least about 5 mg to about 10 mg of the at least one compound.

63. The pharmaceutical kit of claim 60 , wherein the kit further comprises from about 1 to about 60 individual doses.

64. The pharmaceutical kit of claim 60 , wherein the kit comprises from about 10 to about 30 individual doses.

65. The pharmaceutical kit of claim 60 , wherein the kit further comprises from about 12 to about 28 individual doses.

Assignments (4)
RELEASE OF SECURITY INTEREST Recorded Mar 13, 2026
From: ALTER DOMUS (US) LLC
To: ZEVRA THERAPEUTICS, INC.
Reel/Frame 075080/0907 →
SECURITY INTEREST Recorded Apr 8, 2024
From: ZEVRA THERAPEUTICS, INC.
To: ALTER DOMUS (US) LLC
Reel/Frame 067040/0637 →
CHANGE OF NAME Recorded Feb 23, 2024
From: KEMPHARM, INC.
To: ZEVRA THERAPEUTICS, INC.
Reel/Frame 066664/0108 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 14, 2018
From: MICKLE, TRAVIS; GUENTHER, SVEN; MICKLE, CHRISTAL; CHI, GUOCHEN; KANSKI, JAROSLAW; MARTIN, ANDREA K; BERA, BINDU
To: KEMPHARM, INC.
Reel/Frame 044933/0608 →
Continuity (7)
Continuation 15076586 · Mar 21, 2016
Continuation In Part 14817581 · Aug 4, 2015
Continuation In Part 14534852 · Nov 6, 2014
Continuation In Part 13888587 · May 7, 2013
Continuation 12828381 · Jul 1, 2010
Provisional Application 61222718 · Jul 2, 2009
Related Publication 20170226118A1 · Aug 10, 2017