US 20080287866A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0287866 A1 Heller (43) Pub. Date: Nov. 20, 2008 (54) METHODS AND COMPOSITIONS FOR THE Publication Classification TREATMENT OF PAN (51) Int. Cl. (76) Inventor: Adam Heller, Austin, TX (US) A6II 3/31 (2006.01) Correspondence Address: A6IP 25/00 (2006.01) CLARK & ELBNG LLP A6M 3L/00 (2006.01) 101 FEDERAL STREET BOSTON, MA 02110 (US) (21) Appl. No.: 12/012,115 (52) U.S. Cl. ........................................... 604/82: 514/612 (22) Filed: Jan. 31, 2008 Related U.S. Application Data (57) ABSTRACT (60) Provisional application No. 60/887,431, filed on Jan. 31, 2007, provisional application No. 60/930,261, The invention features methods, kits, and compositions for filed on May 15, 2007. the treatment of pain. US 2008/028786.6 A1 Nov. 20, 2008 METHODS AND COMPOSITIONS FOR THE 0006. It is an object of the invention to provide new meth TREATMENT OF PAN ods, kits, and compositions for the treatment of pain and itch. CROSS-REFERENCE TO RELATED SUMMARY OF THE INVENTION APPLICATIONS 0007. Applicants have discovered that oxidizing amines, 0001. This application claims benefit of U.S. Provisional such as N-chloro amines and N-dichloro amines, are useful Ser. No. 60/887,431 filed on Jan. 31, 2007, and U.S. Provi for the treatment of pain and itch. sional Ser. No. 60/930.261, filed on May 15, 2007, each of 0008 Accordingly, in a first aspect the invention features a which is incorporated herein by reference. method of treating pain in a patient in need thereof by topi cally administering to the patient an agent selected from BACKGROUND OF THE INVENTION N-chloro amines and N-dichloro amines in an amount suffi cient to treat the pain. 0002 Chronic pain is one of the most important clinical 0009. The invention also features a method of treating pain problems in all of medicine. For example, it is estimated that at a site in a patient in need thereof by locally injecting at the over 5 million people in the United States are disabled by back site an agent selected from N-chloro amines and N-dichloro pain. The economic cost of chronic back pain is enormous, amines in an amount Sufficient to treat the pain. resulting in over 100 million lost work days annually at an 0010. The invention further features a method of treating estimated cost of S50-100 billion. It has been reported that pain in a patient in need thereof by administering to the approximately 8 million people in the U.S. report that they patient an agent selected from N-chloro amines and experience chronic neck or facial pain and spendan estimated N-dichloro amines in an amount Sufficient to treat the pain, S2 billion a year for treatment. The cost of managing pain for wherein the pain is nociceptive pain, Somatic pain, visceral oncology patients is thought to approach S12 billion. Chronic pain, procedural pain, or inflammatory pain caused by pain disables more people than cancer or heart disease and trauma, Surgery, or an autoimmune disease. In certain costs the American public more than both cancer and heart embodiments the pain is caused by trauma, Surgery, hernia disease combined. In addition to the physical consequences, tion of an intervertebral disk, spinal cord injury, shingles, chronic pain has numerous other costs including loss of HIV/AIDS, cancer related pain, amputation, neurodegenera employment, marital discord, depression and prescription tive disorders, carpal tunnel syndrome, diabetic neuropathy, drug addiction. It goes without saying, therefore, that reduc postherpetic neuralgia, fibromyalgia, a musculoskeletal dis ing the morbidity and costs associated with persistent pain order, or any other painful condition described herein. remains a significant challenge for the healthcare system. 0011. In a related aspect, the invention features a method 0003 Intractable severe pain resulting from injury, illness, of treating itchina patient in need thereof by topically admin scoliosis, spinal disc degeneration, spinal cord injury, malig istering to the patient an agent selected from N-chloroamines nancy, arachnoiditis, chronic disease, pain syndromes (e.g., and N-dichloro amines in an amount sufficient to treat the failed back syndrome, complex regional pain syndrome) and itch. other causes is a debilitating and common medical problem. 0012. In an embodiment of any of the above aspects, the In many patients, the continued use of analgesics, particularly agent is administered locally at the site of pain or itch. drugs like narcotics, are not a viable solution due to tolerance, 0013. In another related aspect, the invention features a kit loss of effectiveness, and addiction potential. including (i) a composition including an agent selected from 0004 Oxidizing agents are widely used as disinfectants. N-chloro amines and N-dichloro amines in an amount suffi Examples of oxidizing disinfectants include aqueous solu cient to treat pain when administered to a patient, and (ii) tions of chlorine, where hypochlorite and hypochlorous acid instructions for topically administering the composition to a co-exist near neutral pH; of iodine, often dissolved as potas patient for the treatment of pain. In certain embodiments, the sium tri-iodide in potassium iodide containing Solutions; of composition is formulated for topical administration (e.g., hydrogen peroxide; of N-chloro-compounds, like Chloram formulated as a cream, lotion, spray, Stick, iontophoresis ine-T, the sodium salt of N-chloro-p-toluenesulfonamide and Solution, or ointment). its salts with other cations or like Chloramine-B, the sodium 0014. The invention also features a kit including (i) a com salt of N-chloro-benzenesulfonamide and its salts with other position formulated for injection and including an agent cations; and of chloramine, NH2Cl, also known as selected from N-chloro amines and N-dichloro amines in an monochloramine; and of oZone. All are bactericidal and/or amount Sufficient to treat pain when administered to a patient, fungicidal, and some also deactivate viruses. Chlorine and the and (ii) instructions for locally injecting the composition at a product of its reaction with water hypochlorous acid, and site of a patient for the treatment of pain. chloramine, as well as oZone, are widely used to disinfect 0015 The invention further features a kit including (i) a municipal drinking water. Oxidizing agents are also applied composition including an agent selected from N-chloro in sterilization, for example of Surgical instruments. amines and N-dichloroamines in an amount Sufficient to treat 0005. Oxidizing agents are also used in treatment of pain when administered to a patient, and (ii) instructions for wounds and disease. Bactericidal oxidizing agents are used administering the composition to a patient for the treatment of also to disinfect wounds, to prevent and control pathogen nociceptive pain, Somatic pain, visceral pain, procedural pain, caused inflammation, to assist in the healing of skin and other or inflammatory pain caused by trauma, Surgery, or an wounds, and to treat pathogen-caused diseases. When used to autoimmune disease. In certain embodiments, the kit further disinfect wounds, they are optionally topically applied, for includes instructions for administering the composition to a example by Swabbing, brushing, spraying, or in a dressing. patient Suffering from pain caused by trauma, Surgery, her They are applied topically also in order to prevent infection niation of an intervertebral disk, spinal cord injury, shingles, before the skin is purposely pierced or cut, for example, prior HIV/AIDS, cancer related pain, amputation, neurodegenera to an injection, withdrawal of a blood sample, or Surgery. tive disorders, carpal tunnel syndrome, diabetic neuropathy, US 2008/028786.6 A1 Nov. 20, 2008 postherpetic neuralgia, fibromyalgia, a musculoskeletal dis N-chloro alpha-aminoisobutyric acid, N-chlorotaurine, order, or any other painful condition described herein. N-chlorotaurine ethyl ester, N-chlorotaurine sulfonamide, 0016. The invention also features a kit including (i) a com N-chloro-acetylglycine, N-chloroalanine, N-chlorobeta-ala position including an agent selected from N-chloro amines nine, N-chloro phenylalanine, N-chloro norvaline, N-chlo and N-dichloro amines in an amount sufficient to treat itch roleucine, N-chloro isoleucine, N-chloroproline, N-chloro when administered to a patient, and (ii) instructions for topi omega aminoundecanoic acid, N-chloroaspartic acid, cally administering the composition to a patient for the treat N-chloroglutamic acid, N-chloroasparagine, N-chlorovaline, ment of itch. N-chlorocystine, N-chloromethionine, N-chloroglutamine, 0017. In a related aspect, the invention features a kit N-chlorotryptophane, N-chlorohistidine, N-chloroarginine, including (i) an inorganic oxide, (ii) an ammonium salt, (iii) a N-chlorolysine. N-chloro alpha-aminobutyric acid, N-chloro hypochlorite salt, (iv) instructions for contacting the inor gamma-aminobutyric acid, N-chloro alpha, epsilon diamino ganic oxide, the ammonium salt, and the hypochlorite salt pimelic acid, N-chloro ornithine, N-chloroanthranilic acid, with water to form a solution, and (V) instructions for admin N-chloro p-aminobenzoic acid, N-chlorosulfanilic acid, istering the Solution to a patient for the treatment of pain or N-chloro orthanilic acid, N-chloro phenyl sulfamic acid, itch. In certain embodiments, the kit further includes a buffer. N-chloroaminopropanesulfonic acid, N-chloro ami In still other embodiments, the