Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline 1,3-dione
Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, substantially free of its (−) isomer, and prodrugs, metabolites, polymorphs, salts, solvates, hydrates, and clathrates thereof are discussed. Also discussed are methods of using and pharmaceutical compositions comprising the (+) enantiomer of 2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-α or the inhibition of PDE4.
1. A method of treating psoriasis, which comprises orally administering to a patient having psoriasis about 10 mg to about 200 mg per day of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, wherein the compound is administered in the form of a tablet or capsule as either a single dose or a divided dose.
2. The method of claim 1 , wherein about 10 mg to about 100 mg of the compound is administered per day.
3. The method of claim 1 , wherein the compound is administered twice daily in equally divided doses.
4. The method of claim 1 , wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.
5. The method of claim 1 , wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.
6. The method of claim 1 , wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.
7. The method of claim 1 , wherein the compound is administered in capsule form.
8. The method of claim 7 , wherein the capsule contains about 10 mg of the compound.
9. The method of claim 7 , wherein the capsule contains about 20 mg of the compound.
10. The method of claim 7 , wherein the capsule contains about 25 mg of the compound.
11. The method of claim 7 , wherein the capsule contains about 50 mg of the compound.
12. The method of claim 11 , wherein the compound is administered in tablet form.
13. The method of claim 12 , wherein the tablet contains about 10 mg of the compound.
14. The method of claim 12 , wherein the tablet contains about 20 mg of the compound.
15. The method of claim 12 , wherein the tablet contains about 25 mg of the compound.
16. The method of claim 12 , wherein the tablet contains about 50 mg of the compound.
17. A method of treating rheumatoid arthritis, which comprises administering to a patient having rheumatoid arthritis a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
18. The method of claim 17 , wherein the compound is administered orally.
19. The method of claim 18 , wherein about 5 mg to about 500 mg of the compound is administered per day.
20. The method of claim 18 , wherein about 10 mg to about 200 mg of the compound is administered per day.
21. The method of claim 18 , wherein about 10 mg to about 100 mg of the compound is administered per day.
22. The method of claim 18 , wherein the compound is administered twice daily in equally divided doses.
23. The method of claim 18 , wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.
24. The method of claim 18 , wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.
25. The method of claim 18 , wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.
26. The method of claim 18 , wherein the compound is administered in capsule form.
27. The method of claim 26 , wherein the capsule contains about 10 mg of the compound.
28. The method of claim 26 , wherein the capsule contains about 20 mg of the compound.
29. The method of claim 26 , wherein the capsule contains about 25 mg of the compound.
30. The method of claim 26 , wherein the capsule contains about 50 mg of the compound.
31. The method of claim 18 , wherein the compound is administered in tablet form.
32. The method of claim 31 , wherein the tablet contains about 10 mg of the compound.
33. The method of claim 31 , wherein the tablet contains about 20 mg of the compound.
34. The method of claim 31 , wherein the tablet contains about 25 mg of the compound.
35. The method of claim 31 , wherein the tablet contains about 50 mg of the compound.
36. A method of treating rheumatoid arthritis, which comprises orally administering to a patient having rheumatoid arthritis about 10 mg to about 100 mg of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione comprising greater than about 97% by weight of (+) isomer wherein the compound is administered in the form of a tablet or capsule twice daily in equally divided doses.
37. A method of treating Behcet's Disease, which comprises administering to a patient having Behcet's Disease a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione.
38. The method of claim 37 , wherein the compound is administered orally.
39. The method of claim 38 , wherein about 5 mg to about 500 mg of the compound is administered per day.
40. The method of claim 38 , wherein about 10 mg to about 200 mg of the compound is administered per day.
41. The method of claim 38 , wherein about 10 mg to about 100 mg of the compound is administered per day.
42. The method of claim 38 , wherein the compound is administered twice daily in equally divided doses.
43. The method of claim 38 , wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.
44. The method of claim 38 , wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.
45. The method of claim 38 , wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.
46. The method of claim 38 , wherein the compound is administered in capsule form.
47. The method of claim 46 , wherein the capsule contains about 10 mg of the compound.
48. The method of claim 46 , wherein the capsule contains about 20 mg of the compound.
49. The method of claim 46 , wherein the capsule contains about 25 mg of the compound.
50. The method of claim 46 , wherein the capsule contains about 50 mg of the compound.
51. The method of claim 38 , wherein the compound is administered in tablet form.
52. The method of claim 51 , wherein the tablet contains about 10 mg of the compound.
53. The method of claim 51 , wherein the tablet contains about 20 mg of the compound.
54. The method of claim 51 , wherein the tablet contains about 25 mg of the compound.
55. The method of claim 51 , wherein the tablet contains about 50 mg of the compound.
56. A method of treating Behcet's Disease, which comprises orally administering to a patient having Behcet's Disease about 10 mg to about 100 mg of stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione comprising greater than about 97% by weight of (+) isomer wherein the compound is administered in the form of a tablet or capsule twice daily in equally divided doses.