Formulation Including a Combination of beta-Endorphin and Adrenocorticotropic Hormone

Abstract

The present specification provides compositions of β-endorphin and adrenocorticotropic hormone (ACTH). These compositions are useful in methods of treating disease.

1 . A method of treating an inflammatory, autoimmune, allergic, or neurologic disease or disorder, comprising administering a clinically effective amount of adrenocorticotropic hormone (ACTH) and β-endorphin, or analogues thereof of either or both, to a person in need thereof. 
     
     
         2 . The method of  claim 1 , wherein said inflammatory, autoimmune, allergic, or neurologic disease or disorder comprises at least one of systemic lupus erythematosus, proteinuria in nephrotic syndrome, polymyositis, symptomatic sarcoidosis, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, severe acute and chronic allergic or inflammatory processes involving the eye, childhood epilepsy, infantile spasms (West syndrome), Lennox-Gastaut syndrome, Landau-Kleffner syndrome, and electrical status epilepticus in sleep. 
     
     
         3 . The method of  claim 1 , wherein treating comprises maintenance therapy, whereby incidences or severity of exacerbations of the disease are reduced. 
     
     
         4 . The method of  claim 1 , wherein the person in need thereof has a family history of the disease or disorder, and the treatment is prophylactic. 
     
     
         5 . The method of  claim 1  comprising administering 40-120 units of ACTH. 
     
     
         6 . The method of  claim 5 , wherein the mass ratio of ACTH:β-endorphin is 2:1. 
     
     
         7 . The method of  claim 1  comprising administering 0.8-1.2 mg of ACTH. 
     
     
         8 . The method of  claim 7 , wherein the mass ratio of ACTH:β-endorphin is 2:1. 
     
     
         9 . The method of  claim 1 , wherein said administration comprises subcutaneous injection. 
     
     
         10 . The method of  claim 1 , wherein said administration comprises intramuscular injection. 
     
     
         11 . The method of  claim 1 , wherein said administration comprises a single injection. 
     
     
         12 . The method of  claim 1 , wherein said administration comprises at least two injections. 
     
     
         13 . The method of  claim 1 , wherein said administration occurs daily. 
     
     
         14 . The method of  claim 1 , wherein said administration occurs once every second day. 
     
     
         15 . The method of  claim 1 , wherein said administration occurs once every third day.