VALACICLOVIR AND MELOXICAM 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 valaciclovir and a therapeutically-effective amount of the COX-2 inhibitor meloxicam. The invention is further related to methods of treating functional somatic syndromes by administering a therapeutically-effective combination of valaciclovir and meloxicam.
1 . A combination comprising a therapeutically-effective amount of valaciclovir and a therapeutically-effective amount of meloxicam, wherein the amount of valaciclovir is present in a unit dosage form from about 750 mg to about 1500 mg, and wherein the amount of meloxicam is present in a unit dosage form from about 15 mg to about 30 mg.
2 . The combination of claim 1 , wherein the amount of valaciclovir is present in a unit dosage form from about 750 mg to about 1050 mg.
3 . The combination of claim 1 , wherein the amount of valaciclovir is present in a unit dosage form from about 1050 mg to about 1500 mg.
4 . The combination of claim 1 , wherein the amount of valaciclovir is present in a unit dosage form selected from the group consisting of about 750 mg, about 1050 mg, about 1250 mg and about 1500 mg.
5 . The combination of claim 1 , wherein the amount of valaciclovir is present in a unit dosage form of about 750 mg or about 1250 mg.
6 . The combination of claim 1 , wherein the amount of meloxicam is present in a unit dosage form of about 15 mg or about 30 mg.
7 . The combination of claim 1 , wherein the amount of valaciclovir is present in a unit dosage form of about 750 mg or about 1250 mg, and wherein the amount of meloxicam is present in a unit dosage form of about 15 mg or about 30 mg.
8 . 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 valaciclovir and meloxicam, wherein the amount of valaciclovir is administered in a total daily dose range from about 750 mg to about 1500 mg, and wherein the amount of meloxicam is administered in a total daily dose range from about 15 mg to about 30 mg, and wherein the combination administered produces no substantial adverse event.
9 . The method of claim 8 , 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.
10 . The method of claim 8 , wherein the condition is fibromyalgia.
11 . The method of claim 8 , wherein the condition is chronic fatigue syndrome.
12 . The method of claim 8 , wherein the condition is irritable bowel syndrome.
13 . The method of claim 8 , wherein the condition is a combination of fibromyalgia, chronic fatigue syndrome and irritable bowel syndrome, coexistent in the subject.
14 . The method of claim 8 , wherein the amount of valaciclovir is administered in a total daily dose range from about 750 mg to about 1250 mg.
15 . The method of claim 8 , wherein the amount of valaciclovir administered in a total daily dose is about 750 mg, and wherein the amount of meloxicam administered in a total daily dose is about 15 mg or about 30 mg.
16 . The method of claim 15 , wherein the condition is fibromyalgia.
17 . A kit presentation, comprising a therapeutically-effective amount of valaciclovir in a first unit dosage form, and a therapeutically-effective amount of meloxicam, 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.
18 . The kit presentation of claim 17 , wherein the amount of valaciclovir is present in a unit dosage form from about 750 mg to about 1500 mg, and wherein the amount of meloxicam is present in a unit dosage form from about 15 mg to about 30 mg.