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Last Updated: January 20, 2020

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Claims for Patent: 9,867,791

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Summary for Patent: 9,867,791
Title:Method of administering amantadine prior to a sleep period
Abstract: Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
Inventor(s): Went; Gregory T. (Mill Valley, CA), Sathyan; Gayatri (Bangalore, IN), Vermani; Kavita (Fremont, CA), Ganapati; Gangadhara (Palo Alto, CA), Coffee; Michael (Tiburon, CA), Shek; Efraim (Pleasanton, CA), Katdare; Ashok (Berkeley, CA)
Assignee: Adamas Pharma, LLC (Emeryville, CA)
Application Number:15/428,899
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,867,791
Patent Claims: 1. A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises: (i) 250 mg to 600 mg of the drug; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC.sub.0-4 for amantadine is less than 5% of AUC.sub.0-inf and the Tmax of amantadine is 8 to 20 hours.

2. A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises: (i) 250 mg to 600 mg of the drug; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC.sub.0-8 for amantadine is 5% to 15% of AUC.sub.0-inf and the Tmax for amantadine is 8 to 20 hours.

3. A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises: (i) 250 mg to 600 mg of the drug; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC.sub.0-4 for amantadine is less than 5% of AUC.sub.0-inf and the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.

4. A method of administering a dose of a pharmaceutical composition of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof to a human patient in need thereof, comprising administering said dose of said pharmaceutical composition to said human patient orally, once daily 0 to 4 hours before bedtime, wherein said dose of said pharmaceutical composition comprises: (i) 250 mg to 600 mg of the drug; and (ii) one or more excipients, wherein at least one of said one or more excipients modifies the release of said drug to provide an extended release dosage form, and wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the fractional AUC.sub.0-8 for amantadine is 5% to 15% of AUC.sub.0-inf and the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.

5. The method of claim 1, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.

6. The method of claim 1, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

7. The method of claim 5, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

8. The method of claim 1, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

9. The method of claim 5, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

10. The method of claim 1, wherein said patient is being treated for Parkinson's disease.

11. The method of claim 5, wherein said patient is being treated for Parkinson's disease.

12. The method of claim 8, wherein said patient is being treated for Parkinson's disease.

13. The method of claim 10, wherein said patient suffers from levodopa-induced dyskinesia.

14. The method of claim 13, wherein the method reduces the frequency or severity of levodopa-induced dyskinesia in said patient.

15. The method of claim 1, wherein said dose of said pharmaceutical composition comprises 1 or 2 unit dosage forms.

16. The method of claim 15, wherein said unit dosage form comprises a capsule.

17. The method of claim 2, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the Cmax for amantadine is 1.0 to 2.4 ng/ml per mg of amantadine.

18. The method of claim 2, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

19. The method of claim 17, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

20. The method of claim 2, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

21. The method of claim 17, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

22. The method of claim 2, wherein said patient is being treated for Parkinson's disease.

23. The method of claim 17, wherein said patient is being treated for Parkinson's disease.

24. The method of claim 20, wherein said patient is being treated for Parkinson's disease.

25. The method of claim 22, wherein said patient suffers from levodopa-induced dyskinesia.

26. The method of claim 25, wherein the method reduces the frequency or severity of levodopa-induced dyskinesia in said patient.

27. The method of claim 2, wherein said dose of said pharmaceutical composition comprises 1 or 2 unit dosage forms.

28. The method of claim 27, wherein said unit dosage form comprises a capsule.

29. The method of claim 3, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

30. The method of claim 3, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

31. The method of claim 3, wherein said patient is being treated for Parkinson's disease.

32. The method of claim 29, wherein said patient is being treated for Parkinson's disease.

33. The method of claim 31, wherein said patient suffers from levodopa-induced dyskinesia.

34. The method of claim 33, wherein the method reduces the frequency or severity of levodopa-induced dyskinesia in said patient.

35. The method of claim 3, wherein said dose of said pharmaceutical composition comprises 1 or 2 unit dosage forms.

36. The method of claim 35, wherein said unit dosage form comprises a capsule.

37. The method of claim 4, wherein when said pharmaceutical composition is dosed in a single dose, fasted, human pharmacokinetic study in healthy subjects, the AUC.sub.0-inf for amantadine is 40 to 75 ng*h/ml per mg of amantadine.

38. The method of claim 4, wherein when said pharmaceutical composition is dosed in a multiple dose, fasted, human pharmacokinetic study in healthy subjects, the steady state AUC.sub.0-24 for amantadine is 44 to 83 ng*h/ml per mg of amantadine.

39. The method of claim 4, wherein said patient is being treated for Parkinson's disease.

40. The method of claim 37, wherein said patient is being treated for Parkinson's disease.

41. The method of claim 39, wherein said patient suffers from levodopa-induced dyskinesia.

42. The method of claim 41, wherein the method reduces the frequency or severity of levodopa-induced dyskinesia in said patient.

43. The method of claim 4, wherein said dose of said pharmaceutical composition comprises 1 or 2 unit dosage forms.

44. The method of claim 43, wherein said unit dosage form comprises a capsule.

45. The method of claim 1, wherein said fractional AUC.sub.0-4 for amantadine, said AUC.sub.0-inf for amantadine and said Tmax for amantadine are determined from one subject of said human pharmacokinetic study.

46. The method of claim 1, wherein said fractional AUC.sub.0-4 for amantadine and said AUC.sub.0-inf for amantadine are mean values determined from said human pharmacokinetic study, and said Tmax for amantadine is the median value determined from said human pharmacokinetic study.

47. The method of claim 2, wherein said fractional AUC.sub.0-8 for amantadine, said AUC.sub.0-inf for amantadine, and said Tmax for amantadine are determined from one subject of said human pharmacokinetic study.

48. The method of claim 2, wherein said fractional AUC.sub.0-8 for amantadine and said AUC.sub.0-inf for amantadine are mean values determined from said human pharmacokinetic study, and said Tmax for amantadine is the median value determined from said human pharmacokinetic study.

49. The method of claim 3, wherein said fractional AUC.sub.0-4 for amantadine, said AUC.sub.0-inf for amantadine, and said Cmax for amantadine are determined from one subject of said human pharmacokinetic study.

50. The method of claim 3, wherein said fractional AUC.sub.0-4 for amantadine, said AUC.sub.0-inf for amantadine, and said Cmax for amantadine are mean values determined from said human pharmacokinetic study.

51. The method of claim 4, wherein said fractional AUC.sub.0-8 for amantadine, said AUC.sub.0-inf for amantadine, and said Cmax for amantadine are determined from one subject of said human pharmacokinetic study.

52. The method of claim 4, wherein said fractional AUC.sub.0-8 for amantadine, said AUC.sub.0-inf for amantadine, and said Cmax for amantadine are mean values determined from said human pharmacokinetic study.

53. The method of claim 1, wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug.

54. The method of claim 2, wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug.

55. The method of claim 3, wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug.

56. The method of claim 4, wherein said pharmaceutical composition is selected from the group consisting of one unit dosage form comprising 340 mg of said drug and two unit dosage forms each comprising 170 mg of said drug.

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