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Details for Patent: 9,283,207

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Details for Patent: 9,283,207

Title:Methods of using (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione
Abstract: Stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-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-acetylaminoisoin- doline-1,3-dione are disclosed. The methods include methods of treating and/or preventing disorders ameliorated by the reduction of levels of TNF-.alpha. or the inhibition of PDE4.
Inventor(s): Muller; George W. (Rancho Santa Fe, CA), Schafer; Peter H. (Belle Mead, NJ), Man; Hon-Wah (Princeton, NJ), Ge; Chuansheng (Belle Mead, NJ)
Assignee: Celgene Corporation (Summit, NJ)
Filing Date:Jun 26, 2014
Application Number:14/316,160
Claims:1. A method of treating a disease or disorder selected from Crohn's Disease or ulcerative colitis, the method comprising administering to a patient having a Crohn's Disease or ulcerative colitis a therapeutically effective amount of a compound which is stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, or a pharmaceutically acceptable salt thereof.

2. The method of claim 1 further comprising administering to the patient a therapeutically effective amount of an antihistamine, anti-inflammatory drug, non-steroid anti-inflammatory drug, or steroid.

3. The method of claim 1 wherein the compound is administered parenterally, transdermally, mucosally, nasally, buccally, sublingually, or orally.

4. The method of claim 3 wherein the compound is administered orally.

5. The method of claim 4 wherein the compound is administered orally in a tablet or capsule form.

6. The method of claim 1 wherein the therapeutically effective amount is from about 1 mg to about 1000 mg per day.

7. The method of claim 6 wherein the therapeutically effective amount is from about 5 mg to about 500 mg per day.

8. The method of claim 7 wherein the therapeutically effective amount is from about 10 mg to about 200 mg per day.

9. The method of claim 1, wherein the disease or disorder is Crohn's Disease.

10. The method of claim 1, wherein the disease or disorder is ulcerative colitis.

11. The method of claim 4, wherein the compound is administered twice daily in equally divided doses.

12. The method of claim 4, wherein the stereomerically pure compound comprises greater than about 90% by weight of (+) isomer based on the total weight percent of the compound.

13. The method of claim 4, wherein the stereomerically pure compound comprises greater than about 95% by weight of (+) isomer based on the total weight percent of the compound.

14. The method of claim 4, wherein the stereomerically pure compound comprises greater than about 97% by weight of (+) isomer based on the total weight percent of the compound.

15. The method of claim 5, wherein the capsule contains about 10 mg of the compound.

16. The method of claim 5, wherein the capsule contains about 20 mg of the compound.

17. The method of claim 5, wherein the capsule contains about 25 mg of the compound.

18. The method of claim 5, wherein the capsule contains about 50 mg of the compound.

19. The method of claim 5, wherein the tablet contains about 10 mg of the compound.

20. The method of claim 5, wherein the tablet contains about 20 mg of the compound.

21. The method of claim 5, wherein the tablet contains about 25 mg of the compound.

22. The method of claim 5, wherein the tablet contains about 50 mg of the compound.

23. A method of treating Crohn's Disease, which comprises orally administering to a patient having Crohn's Disease about 10 mg to about 100 mg of a compound which is stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-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.

24. A method of treating ulcerative colitis, which comprises orally administering to a patient having ulcerative colitis about 10 mg to about 100 mg of a compound which is stereomerically pure (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-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.
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