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Last Updated: November 30, 2020

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Claims for Patent: 9,867,793

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Summary for Patent: 9,867,793
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:15/430,084
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,867,793
Patent Claims: 1. A method of treating levodopa-induced dyskinesia (LID) in a human patient with Parkinson's disease, comprising orally administering to said human patient with Parkinson's disease and levodopa-induced dyskinesia, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer, wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer, wherein said one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles) at 50 rpm with 500 ml of water at 37.degree. C. as the dissolution medium, and wherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study.

2. A method of administering amantadine, or a pharmaceutically acceptable salt thereof, to a patient in need thereof, comprising orally administering to said patient in need thereof, once daily 0 to 4 hours before bedtime, a pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets, wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer, wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer, wherein the one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles at 50 rpm with 500 ml of water at 37.degree. C. as the dissolution medium, and wherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study.

3. A method of reducing sleep disturbances in a subject taking amantadine, comprising orally administering to said subject taking amantadine a pharmaceutical composition once daily 0 to 4 hours before bedtime, the pharmaceutical composition comprising 220 mg to 455 mg of a drug selected from the group consisting of amantadine and pharmaceutically acceptable salts thereof, in an extended release dosage form, wherein said extended release dosage form comprises one or more capsules each containing one or more pellets wherein each of said one or more pellets comprises: a) a pellet core comprising said drug; and b) surrounding the pellet core, an extended release coating layer comprising an extended release coating polymer, a pore former, and a plasticizer, wherein said drug is present at a weight percent of from 40% to 80% based on the combined weight of said pellet core and said extended release coating layer, wherein said extended release coating layer is present at a weight percent from 10% to 30% based on the combined weight of said pellet core and said extended release coating layer, wherein the one or more capsules have an in vitro dissolution profile of said drug of not more than 10% at 1 hour, not more than 25% at 2 hours, and at least 80% at 12 hours, using a USP Apparatus II (Paddles) at 50 rpm with 500 ml of water at 37.degree. C. as the dissolution medium, and wherein the extended release dosage form has a Tmax for amantadine of 8 hours to 18 hours when the Tmax of the extended release form is determined in a fasted single dose human pharmacokinetic study.

4. The method of claim 1, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours.

5. The method of claim 1, wherein said extended release coating polymer comprises ethyl cellulose.

6. The method of claim 5, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer.

7. The method of claim 1, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof.

8. The method of claim 1, wherein the method reduces the severity or frequency of dyskinesia.

9. The method of claim 1, wherein said Tmax for amantadine is 12 hours to 18 hours.

10. The method of claim 1, wherein said pellet core further comprises a seed core and a binder.

11. The method of claim 10, wherein said seed core is a cellulose sphere.

12. The method of claim 10, wherein said binder comprises hydroxypropyl methylcellulose.

13. The method of claim 1, wherein said extended release dosage form comprises one, two,. or three capsules.

14. The method of claim 2, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours.

15. The method of claim 2, wherein said extended release coating polymer comprises ethyl cellulose.

16. The method of claim 15, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer.

17. The method of claim 2, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof.

18. The method of claim 2, wherein the said Tmax for amantadine is 12 hours to 18 hours.

19. The method of claim 2, wherein said pellet core further comprises a seed core and a binder.

20. The method of claim 19, wherein said seed core is a cellulose sphere.

21. The method of claim 20, wherein said binder comprises hydroxypropyl methylcellulose.

22. The method of claim 2, wherein the extended release dosage form comprises one, two, or three capsules.

23. The method of claim 3, wherein the one or more capsules have an in vitro dissolution profile of said drug of 25% to 55% at 6 hours.

24. The method of claim 3, wherein said extended release coating polymer comprises ethyl cellulose.

25. The method of claim 24, wherein said ethyl cellulose is present in an amount of 5 to 20% based on the combined weight of said pellet core and said extended release coating layer.

26. The method of claim 3, wherein the pharmaceutical composition comprises 260 mg to 420 mg of amantadine or a pharmaceutically acceptable salt thereof.

27. The method of claim 3, wherein said Tmax for amantadine is 12 hours to 18 hours.

28. The method of claim 3, wherein said pellet core further comprises a seed core and a binder.

29. The method of claim 28, wherein said seed core is a cellulose sphere.

30. The method of claim 28, wherein said binder comprises hydroxypropyl methylcellulose.

31. The method of claim 3, wherein said extended release dosage form comprises one, two, or three capsules.

32. The method of claim 1, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug.

33. The method of claim 32, wherein said drug is a pharmaceutically acceptable salt of amantadine.

34. The method of claim 32, wherein said drug is amantadine hydrochloride.

35. The method of claim 2, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug.

36. The method of claim 35, wherein said drug is a pharmaceutically acceptable salt of amantadine.

37. The method of claim 35, wherein said drug is amantadine hydrochloride.

38. The method of claim 3, wherein said extended release dosage form is selected from the group consisting of one capsule comprising 340 mg of said drug and two capsules each comprising 170 mg of said drug.

39. The method of claim 38, wherein said drug is a pharmaceutically acceptable salt of amantadine.

40. The method of claim 38, wherein said drug is amantadine hydrochloride.

41. The method of claim 1, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer.

42. The method of claim 2, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer.

43. The method of claim 3, wherein said drug is present at a weight percent of from 40% to 65% based on the combined weight of said pellet core and said extended release coating layer.

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