Famciclovir and celecoxib combination therapy kit for functional somatic syndromes

Abstract

The present invention relates to methods of treating fibromyalgia, by administering a therapeutically-effective combination of an antiviral component and a COX-2 inhibitor component. The invention is further related to pharmaceutical compositions comprising a combination of a therapeutically-effective amount of the antiviral compound famciclovir and a therapeutically-effective amount of the COX-2 inhibitor celecoxib. The invention is also related to methods of treating functional somatic syndromes by administering a therapeutically-effective combination of famciclovir and celecoxib.

1 - 29 . (canceled) 
     
     
         30 . A kit presentation, comprising a therapeutically-effective amount of famciclovir in a first unit dosage form, and a therapeutically-effective amount of a celecoxib in a second unit dosage form, wherein each of the first and second unit dosage forms is enclosed in one or more containers, the kit comprising printed directions for administration of kit components to obtain a chronic-disease-treatment therapeutic outcome, and wherein the printed directions comprise a chronic-disease-treatment regimen instruction sheet, for treatment of a chronic disease selected from the group consisting of fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome, the regimen instruction sheet further comprising instructions for a two-stage-regimen treatment-period comprising:
 (a) a first stage of an initial seven days of the treatment-period for administering a coacting-combination loading-dose amount of famciclovir in a unit dose in a range of about 500 mg to about 1000 mg, and a coacting-combination loading-dose amount of celecoxib in a unit dose in a range of about 100 mg to about 400 mg; and   (b) a second stage of the remainder of the treatment-period for administering a coacting-combination maintenance-dose amount of famciclovir in a unit dose in a range of about 125 mg to about 1000 mg, and a coacting-combination maintenance-dose amount of celecoxib in a unit dose in a range of about 100 mg to about 200 mg.   
     
     
         31 . The kit presentation of  claim 30 , wherein the chronic disease is fibromyalgia, and wherein each of famciclovir and celecoxib is administered twice-per-day during the first stage and the second stage. 
     
     
         32 . The kit presentation of  claim 31 , wherein famciclovir is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 1250 mg to about 1500 mg and wherein celecoxib is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 300 mg to about 400 mg. 
     
     
         33 . The kit presentation of  claim 31 , wherein the two-stage-regimen treatment-period comprises:
 (a) a first stage of an initial seven days of the treatment-period for administering a coacting-combination loading-dose amount of famciclovir in a unit dose of about 500 mg or about 1000 mg, and a coacting-combination loading-dose amount of celecoxib in a unit dose of about 200 mg or about 400 mg; and   (b) a second stage of the remainder of the treatment-period for administering a coacting-combination maintenance-dose amount of famciclovir in a unit dose of about 125 mg, about 250 mg, or about 500 mg, and a coacting-combination maintenance-dose amount of celecoxib in a unit dose of about 100 mg or about 200 mg.   
     
     
         34 . The kit presentation of  claim 30 , wherein the chronic disease is chronic fatigue syndrome, and wherein each of famciclovir and celecoxib is administered twice-per-day during the first stage and the second stage. 
     
     
         35 . The kit presentation of  claim 34 , wherein famciclovir is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 1250 mg to about 1500 mg and wherein celecoxib is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 300 mg to about 400 mg. 
     
     
         36 . The kit presentation of  claim 34 , wherein the two-stage-regimen treatment-period comprises:
 (a) a first stage of an initial seven days of the treatment-period for administering a coacting-combination loading-dose amount of famciclovir in a unit dose of about 500 mg or about 1000 mg, and a coacting-combination loading-dose amount of celecoxib in a unit dose of about 200 mg or about 400 mg; and   (b) a second stage of the remainder of the treatment-period for administering a coacting-combination maintenance-dose amount of famciclovir in a unit dose of about 125 mg, about 250 mg, or about 500 mg, and a coacting-combination maintenance-dose amount of celecoxib in a unit dose of about 100 mg or about 200 mg.   
     
     
         37 . The kit presentation of  claim 30 , wherein the chronic disease is irritable bowel syndrome, and wherein each of famciclovir and celecoxib is administered twice-per-day during the first stage and the second stage. 
     
     
         38 . The kit presentation of  claim 37 , wherein famciclovir is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 1250 mg to about 1500 mg and wherein celecoxib is present in a total-daily-loading-dose and total-daily-maintenance-dose amount in a range of about 300 mg to about 400 mg. 
     
     
         39 . The kit presentation of  claim 37 , wherein the two-stage-regimen treatment-period comprises:
 (a) a first stage of an initial seven days of the treatment-period for administering a coacting-combination loading-dose amount of famciclovir in a unit dose of about 500 mg or about 1000 mg, and a coacting-combination loading-dose amount of celecoxib in a unit dose of about 200 mg or about 400 mg; and   (b) a second stage of the remainder of the treatment-period for administering a coacting-combination maintenance-dose amount of famciclovir in a unit dose of about 125 mg, about 250 mg, or about 500 mg, and a coacting-combination maintenance-dose amount of celecoxib in a unit dose of about 100 mg or about 200 mg.