Oxymetazoline For The Treatment Of Ano-Rectal Disorders

Abstract

Methods for treating fecal incontinence by administering to a subject in need thereof compositions including oxymetazoline as an active ingredient. Kits including compositions of oxymetazoline suitable for topical application, for the treatment of fecal incontinence.

What is claimed is: 
     
         1 . A method comprising: administering inside the anal cavity of a patient a pharmaceutical composition comprising oxymetazoline or a pharmaceutically acceptable salt or derivative thereof as an active ingredient, wherein a concentration of the active ingredient is within a therapeutically effective range of 0.05% to 1% to treat fecal incontinence. 
     
     
         2 . The method of  claim 1 , wherein the active ingredient is oxymetazoline hydrochloride. 
     
     
         3 . The method of  claim 1 , wherein the composition further comprises at least one carrier, diluent, excipient or combinations thereof. 
     
     
         4 . The method of  claim 1 , wherein the pharmaceutical composition is selected from the group consisting of: long acting, controlled release, slow release, sustained release, bioadhesive and mucoadhesive. 
     
     
         5 . The method of  claim 1 , wherein the pharmaceutical composition is in a dosage form selected from the group consisting of: gel, cream, paste, spray suppository, mousse, emollient, powder, solution, suspension and foam. 
     
     
         6 . The method of  claim 1 , wherein to treat fecal incontinence refers to reducing or preventing fecal incontinence, increasing the resting anal pressure of the patient, maintaining a high resting anal pressure for at least one hour of the patient, and strengthening the anal sphincter muscles of the patient thereby preventing leakage and improving the rectum sensation. 
     
     
         7 . The method of  claim 1 , wherein the concentration of the active ingredient is within the range of 0.08 to 0.8%. 
     
     
         8 . The method of  claim 1 , wherein the patient is effectively treated for fecal incontinence for at least 4 hours. 
     
     
         9 . A kit comprising: (a) a first dosage form comprising as sole active ingredient oxymetazoline or a pharmaceutically acceptable salt or derivative thereof, wherein a concentration of oxymetazoline in the first dosage form is within a therapeutically effective range of 0.05 to 1% to treat fecal incontinence; and (b) means for storing the dosage form. 
     
     
         10 . The kit of  claim 9  further comprising a second dosage form comprising a therapeutic agent selected from the group consisting of: NO synthase inhibitor, prostaglandin F2a, dopamine, morphine, loperamide, β-blockers, sodium valproate, codeine phosphate and 5-Hydroxytryptamine. 
     
     
         11 . The kit of  claim 9 , wherein the first dosage form and the second dosage form are contained in separate containers. 
     
     
         12 . The kit of  claim 9 , wherein the first dosage form comprises oxymetazoline hydrochloride. 
     
     
         13 . A pharmaceutical composition comprising: a gel consisting essentially of oxymetazoline or a pharmaceutically acceptable salt or derivative thereof as an active ingredient, wherein a concentration of the active ingredient is within a therapeutically effective range of 0.05% to 1% to treat fecal incontinence. 
     
     
         14 . The pharmaceutical composition of  claim 13 , wherein the active ingredient is oxymetazoline hydrochloride. 
     
     
         15 . The pharmaceutical composition of  claim 13 , wherein the composition further comprises at least one carrier, diluent, excipient or combinations thereof. 
     
     
         16 . The pharmaceutical composition of  claim 13 , wherein the pharmaceutical composition is selected from the group consisting of: long acting, controlled release formulation, a sustained release formulation, bioadhesive formulation, mucoadhesive formulation, and a slow release formulation. 
     
     
         17 . The pharmaceutical composition of  claim 13 , wherein the concentration of the active ingredient is within the range of 0.08 to 0.8%. 
     
     
         18 . The pharmaceutical composition of  claim 13 , wherein the pharmaceutical composition after being administered to a patient is effective for treating the patient for fecal incontinence for at least 4 hours. 
     
     
         19 . The method of  claim 1 , wherein the pharmaceutical composition consists of oxymetazoline or a pharmaceutically acceptable salt or derivative thereof as an active ingredient. 
     
     
         20 . The pharmaceutical composition of  claim 13 , wherein the pharmaceutical composition consists of oxymetazoline or a pharmaceutically acceptable salt or derivative thereof as an active ingredient.