ACICLOVIR AND CELECOXIB COMBINATION THERAPY FOR FUNCTIONAL SOMATIC SYNDROMES
The present invention relates to pharmaceutical compositions comprising a combination of a therapeutically-effective amount of the antiviral compound aciclovir and a therapeutically-effective amount of the COX-2 inhibitor celecoxib. The invention is further related to methods of treating functional somatic syndromes by administering a therapeutically-effective combination of aciclovir and celecoxib.
1 . A combination comprising a therapeutically-effective amount of aciclovir and a therapeutically-effective amount of celecoxib, wherein the amount of aciclovir is present in a unit dosage form from about 400 mg to about 1600 mg, and wherein the amount of celecoxib is present in a unit dosage form from about 100 mg to about 800 mg.
2 . The combination of claim 1 , wherein the amount of aciclovir is present in a unit dosage form from about 400 mg to about 800 mg.
3 . The combination of claim 1 , wherein the amount of aciclovir is present in a unit dosage form from about 800 mg to about 1600 mg.
4 . The combination of claim 1 , wherein the amount of aciclovir is present in a unit dosage form selected from the group consisting of about 400 mg, about 800 mg, about 1200 mg and about 1600 mg.
5 . The combination of claim 1 , wherein the amount of aciclovir is present in a unit dosage form of about 400 mg or about 800 mg.
6 . The combination of claim 1 , wherein the amount of celecoxib is present in a unit dosage form from about 100 mg to about 400 mg.
7 . The combination of claim 1 , wherein the amount of celecoxib is present in a unit dosage form from about 400 mg to about 800 mg.
8 . The combination of claim 1 , wherein the amount of celecoxib is present in a unit dosage form selected from the group consisting of about 100 mg, about 200 mg, about 400 mg and about 800 mg.
9 . The combination of claim 1 , wherein the amount of celecoxib is present in a unit dosage form of about 200 mg or about 400 mg.
10 . The combination of claim 1 , wherein the amount of aciclovir is present in a unit dosage form of about 400 mg or about 1200 mg, and wherein the amount of celecoxib is present in a unit dosage form of about 200 mg or about 400 mg.
11 . A method to treat a subject susceptible to or afflicted with one or more functional somatic syndrome conditions comprising: fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, chronic pain, chronic headache, chronic neck pain, chronic back pain, chronic depression, chronic clinical anxiety disorder, post-traumatic stress disorder (PTSD), brain fog, cognitive dysfunction and chronic interstitial cystitis, the method comprising administering to the subject a therapeutically-effective combination of aciclovir and celecoxib, wherein the amount of aciclovir is administered in a total daily dose range from about 400 mg to about 1600 mg, and wherein the amount of celecoxib is administered in a total daily dose range from about 200 mg to about 800 mg, and wherein the combination administered produces no substantial adverse event.
12 . The method of claim 11 , wherein the condition is selected from the group consisting of fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, chronic depression, chronic clinical anxiety disorder and chronic interstitial cystitis.
13 . The method of claim 11 , wherein the condition is fibromyalgia.
14 . The method of claim 11 , wherein the condition is chronic fatigue syndrome.
15 . The method of claim 11 , wherein the condition is irritable bowel syndrome.
16 . The method of claim 11 , wherein the condition is a combination of fibromyalgia, chronic fatigue syndrome and irritable bowel syndrome, coexistent in the subject.
17 . The method of claim 11 , wherein the amount of aciclovir is administered in a total daily dose range from about 400 mg to about 1200 mg, and wherein the amount of celecoxib is administered in a total daily dose range from about 200 mg to about 500 mg.
18 . The method of claim 11 , wherein the amount of aciclovir administered in a total daily dose is about 800 mg, and wherein the amount of celecoxib administered in a total daily dose is about 400 mg.
19 . The method of claim 18 , wherein the condition is fibromyalgia.
20 . A kit presentation, comprising a therapeutically-effective amount of aciclovir in a first unit dosage form, and a therapeutically-effective amount of celecoxib, in a second unit dosage form, wherein the first and second unit dosage forms are separately enclosed in one or more containers, arranged in a single package or dispensing device, optionally comprising directions on how to use kit components suitable for administration to obtain a therapeutic outcome.
21 . The kit presentation of claim 20 , wherein the amount of aciclovir is present in a unit dosage form from about 400 mg to about 1600 mg, and wherein the amount of celecoxib is present in a unit dosage form from about 100 mg to about 800 mg.