Methods of use related to xerostomia

Abstract

The present invention relates to new uses of thermally stable, crystalline S-2-(3-aminopropylamino)ethyl dihydrogen phosphorothioate, (amifostine) and other aminothiol compounds to treat and reverse toxicities caused by radiation treatment. In particular, the invention provides a method for treating or preventing xerostomia associated with the administration of radiation treatment of head and neck cancer.

1 - 21 . (canceled) 
     
     
         22 . A method for treating xerostomia associated with radiation therapy for head and neck cancer in a human, which comprises administering to said human a therapeutically effective amount of a lyophilized dosage form comprising a thermally stable, sterile, crystalline amifostine trihydrate, wherein the dosage of the crystalline amifostine trihydrate is about 200 mg/m 2 . 
     
     
         23 - 24 . (canceled) 
     
     
         25 . The method of  claim 22 , wherein the crystalline amifostine trihydrate exhibits substantially the crystal structure having a space group of P2 1 2 1 2 1  and cell dimensions of about a=8.46 Å, b=21.55 Å and c=6.76 Å. 
     
     
         26 . The method of  claim 25 , wherein the crystalline amifostine trihydrate forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40° C. for one week. 
     
     
         27 . The method of  claim 25 , wherein the crystalline amifostine trihydrate forms less than about 2% 2-[(3-aminopropyl)amino]ethane thiol when sealed in a nitrogen filled vial and heated to 40° C. for four weeks. 
     
     
         28 . The method of  claim 25 , wherein the crystalline amifostine trihydrate is thermally stable at about 4° C. for at least two years. 
     
     
         29 . The method of  claim 25 , wherein the crystalline amifostine trihydrate is thermally stable at about ambient temperature for at least two years. 
     
     
         30 . (canceled) 
     
     
         31 . The method of  claim 22 , wherein the dosage form further comprises an excipient. 
     
     
         32 . The method of  claim 31 , wherein the excipient is mannitol. 
     
     
         33 - 36 . (canceled) 
     
     
         37 . The method of  claim 22 , wherein the dosage form is administered before the radiation therapy. 
     
     
         38 . The method of  claim 22 , wherein the dosage form is administered after the radiation therapy. 
     
     
         39 . The method of  claim 22 , wherein the dosage form is administered during the radiation therapy. 
     
     
         40 . A method for treating xerostomia associated with radiation therapy for head and neck cancer in a human, which comprises administering to said human a therapeutically effective amount of a dosage form comprising a thermally stable, sterile, crystalline amifostine trihydrate, wherein the dosage of the crystalline amifostine trihydrate is about 200 mg/m 2  administered by intravenous infusion for 3 minutes.