Pharmaceutical formulations of nitrite and uses thereof

Abstract

The present invention relates to pharmaceutical compositions of nitrites such as inorganic nitrites, or any pharmaceutically acceptable salts, solvates, or prodrugs thereof, and the medical use of these compositions. The pharmaceutical compositions, which can be formulated for oral administration, can provide immediate release or extended release of the nitrite ion (NO 2 − ). The pharmaceutical compositions of the invention are useful, for example, for modulating brain function, in particular improving mood and/or psychological state, in the treatment of disorders of brain development, and in the treatment and/or reduction of pain.

What is claimed is: 
     
         1 . A method of treating or reducing neuropathic pain that does not originate with an initial trauma, injury, or infection, wherein the method comprises orally administering about 5 mg to about 50 mg of inorganic nitrite or a pharmaceutically acceptable salt thereof in tablet or capsule form and formulated for sustained release of inorganic nitrite to a human subject, wherein said administering is twice daily for a duration sufficient to treat or reduce the neuropathic pain. 
     
     
         2 . The method of  claim 1 , further comprising monitoring whether the subject experiences reduced neuropathic pain. 
     
     
         3 . The method of  claim 2 , wherein reduced neuropathic pain is measured as a decrease in pain intensity, frequency, duration, and/or improvements in quality of life. 
     
     
         4 . The method of  claim 1 , wherein said subject has type 1 diabetes or type 2 diabetes. 
     
     
         5 . The method of  claim 1 , wherein said subject does not have a condition associated with chronic ischemia. 
     
     
         6 . The method of  claim 1 , wherein said subject has chronic neuropathic pain. 
     
     
         7 . The method of  claim 6 , wherein said chronic neuropathic pain is associated with lower back pain, arthritis, headache, multiple sclerosis, fibromyalgia, nerve damage, or cancer. 
     
     
         8 . The method of  claim 1 , wherein said neuropathic pain is selected from the group consisting of diabetic peripheral neuropathy, post-herpetic neuralgia, trigeminal neuralgia, phantom limb pain, carpal tunnel syndrome, sciatica, pudendal neuralgia, complex regional pain syndrome, sensory polyneuropathys, mono-neuropathies, and central pain syndrome 
     
     
         9 . The method of  claim 8 , wherein said neuropathic pain is diabetic peripheral neuropathy. 
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 1 , wherein said inorganic nitrite is NaNO 2  or KNO 2 . 
     
     
         12 . The method of  claim 11 , wherein said inorganic nitrite is NaNO 2 . 
     
     
         13 . The method of  claim 1 , wherein said inorganic nitrite or a pharmaceutically acceptable salt thereof is administered for at least ten days. 
     
     
         14 .- 15 . (canceled)