Compositions and methods for treating multiple sclerosis

Abstract

Provided are compositions and methods for treating multiple sclerosis (MS). One embodiment of the disclosed method entails orally administering to a MS patient a first amount of aspirin and a second amount of fumaric acid or an ester or a salt thereof. In some embodiments, the aspirin is administered at from about 80 mg to about 500 mg per day and the fumaric acid or ester or salt thereof is administered at about 360 mg per day.

1 - 11 . (canceled) 
     
     
         12 . A capsule comprising a dosage form comprising an effective amount of aspirin and an effective amount a fumaric acid or an ester or a salt thereof, wherein the aspirin and fumaric acid or an ester or a salt thereof are each individually formulated as enterically coated microspheres contained within a capsule shell. 
     
     
         13 . The capsule of  claim 12 , wherein the capsule is coated with a second dose of aspirin formulated to dissolve in an oral cavity of a subject. 
     
     
         14 . The capsule of  claim 13 , comprising from about 20 mg to about 500 mg of aspirin. 
     
     
         15 . A method of treating multiple sclerosis (MS) in a human patient in need thereof, comprising orally administering to the patient a dosage form comprising aspirin and fumaric acid or an ester or a salt thereof, wherein the aspirin is administered at from about 150 mg to about 650 mg per day and the fumaric acid or ester or salt thereof is administered at about 300 mg to about 450 mg per day. 
     
     
         16 . The method of  claim 15 , wherein at least a portion of the aspirin is formulated to dissolve in an oral cavity of a subject. 
     
     
         17 . The method of  claim 15  or  16 , wherein the fumaric acid or ester or salt thereof is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject. 
     
     
         18 . The method of  claim 15 , wherein the pharmaceutical composition is in the form of a capsule. 
     
     
         19 . A method of treating multiple sclerosis (MS) , psoriasis, a motor neuron disease, a neurodegenerative disease, an autoimmune disease, an inflammatory disease, sepsis, or a skin disease in a human patient in need thereof, comprising orally administering to the patient one or more tablets each comprising a first portion comprising a first amount of aspirin and a second portion comprising a second amount of fumaric acid or an ester or a salt thereof,
 wherein the first portion is formulated to dissolve in an oral cavity of a subject,   wherein the second portion is formulated for dissolving in stomach, intestines, or further distal in the gastrointestinal tract of the subject, and   wherein the aspirin is administered at from about 150 mg to about 650 mg per day and the fumaric acid or ester or salt thereof is administered at about 300 mg to about 450 mg per day.   
     
     
         20 . The method of  claim 19 , wherein the patient suffers from relapse-remitting MS (RRMS). 
     
     
         21 . The method of  claim 19 , wherein the patient has a history of non-compliance with a medication due to cutaneous flush or a gastrointestinal side effect. 
     
     
         22 . The method of  claim 19 , wherein the second amount of the fumaric acid or ester or salt thereof is about 180 mg. 
     
     
         23 . The method of  claim 22 , wherein the first amount of aspirin is from about 80 mg to about 250 mg. 
     
     
         24 . The method of  claim 22 , wherein the second portion further comprises a third amount of aspirin. 
     
     
         25 . The method of  claim 24 , wherein the first amount of aspirin and the second amount of aspirin each is from about 20 mg to about 120 mg or from about 80 mg to about 120 mg. 
     
     
         26 . The method of  claim 22 , wherein the second portion is enclosed in an enteric coating. 
     
     
         27 . The method of  claim 19 , wherein the ester is dimethyl fumarate, monomethyl fumarate or combination thereof. 
     
     
         28 - 48 . (canceled)