Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-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 erythema nodosum leprosum in leprosy, rhematoid spondylitis, hepatitis or congestive heart failure which comprises administering to a patient a therapeutically effective amount of stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable prodrug, or salt thereof.
2. The method of claim 1 further comprising administering to a patient in need of such treatment a therapeutically effective amount of an antihistamine, anti-inflammatory drug, non-steroid anti-inflammatory drug or steroid.
3. The method of claim 1 or 2 wherein the patient is a mammal.
4. The method of claim 1 or 2 wherein the stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione is administered parenterally, transdermally, mucosally, nasally, buccally, sublingually, or orally.
5. The method of claim 4 wherein the stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione is administered orally.
6. The method of claim 5 wherein the stereomerically pure (+)-2-[1-(3-Ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-1,3-dione is administered orally in a tablet or capsule form.
7. The method of claim 6 wherein the therapeutically effective amount is from about 1 mg to about 1000 mg per day.
8. The method of claim 7 wherein the therapeutically effective amount is from about 5 mg to about 500 mg per day.
9. The method of claim 8 wherein the therapeutically effective amount is from about 10 mg to about 200 mg per day.
10. The method of claim 8 wherein the therapeutically effective amount is from about 20 mg per day.
11. The method of claim 8 wherein the therapeutically effective amount is from about 20 mg twice daily.