Formulation of a riluzole solution with beta- cyclodextrins

Abstract

The present invention provides methods for parenterally administering riluzole to subjects in need of treatment.

What is claimed is: 
     
         1 . A method for treating a subject in need thereof, the method comprising parenterally administering to the subject riluzole at a dose that is less than 10 mg per day. 
     
     
         2 . The method of  claim 1 , wherein the parenterally administered daily dose is about 0.4 mg to about 9.5 mg or about 0.4 mg to about 7.5 mg. 
     
     
         3 . The method of  claim 1 , wherein the parenterally administered daily dose is about 0.4 mg to about 5 mg. 
     
     
         4 . The method of  claim 1 , wherein the parenterally administered daily dose is about 0.4 mg to about 4 mg. 
     
     
         5 . The method of  claim 1 , wherein the parenterally administered daily dose is about 0.1 mg to about 4 mg. 
     
     
         6 . The method of  claim 1 , wherein the parenterally administered daily dose is about 1 mg to about 4 mg. 
     
     
         7 . The method of  claim 1 , wherein the parenterally administered riluzole is injected or infused into the subject's brain, spinal cord, or a cerebral ventricle. 
     
     
         8 . The method of  claim 1 , wherein the parenterally administered riluzole is intrathecally administered and, optionally, wherein administration occurs continuously. 
     
     
         9 . The method of  claim 7 , wherein parenteral administration does not result in a substantial increase in serum AUC of riluzole or a metabolite thereof. 
     
     
         10 . The method of  claim 7 , wherein the subject is also orally administered riluzole. 
     
     
         11 . The method of  claim 1 , wherein the parenterally administered riluzole is formulated as a composition comprising about 0.4 mg to about 10 mg per ml of riluzole dissolved in at least 1% (w/v) ß-cyclodextrin and an aqueous solvent, and wherein the composition a pH of about 5 to about 8. 
     
     
         12 . The method of  claim 11 , wherein the parenterally administered riluzole composition comprises about 0.4 mg to about 10 mg per ml of riluzole dissolved in about 1% (w/v) to about 15% (w/v) ß-cyclodextrin and an aqueous solvent. 
     
     
         13 . The method of  claim 11 , wherein the parenterally administered parenterally administered riluzole composition comprises about 0.4 mg to about 10 mg per ml of riluzole dissolved in about 1% (w/v) to about 10% (w/v) ß-cyclodextrin and an aqueous solvent. 
     
     
         14 . The method of  claim 11 , wherein the parenterally administered riluzole composition comprises about 0.4 mg to about 4 mg per ml of riluzole dissolved in about 1% (w/v) to about 5% (w/v) ß-cyclodextrin and an aqueous solvent. 
     
     
         15 . The method of any one of  claim 11 , wherein the parenterally administered riluzole composition further comprises one or more pharmaceutically acceptable excipient and/or one or more additional active ingredient. 
     
     
         16 . The method of  claim 11 , wherein the ß-cyclodextrin is selected from the group consisting of 2,6-di-O-methyl-β-cyclodextrin, 2-hydroxypropyl-β-cyclodextrin, and sulfobutylether β-cyclodextrin. 
     
     
         17 . The method of  claim 11 , wherein the aqueous solvent is water, saline, or dextrose. 
     
     
         18 . The method of  claim 1 , wherein treatment alleviates one or more symptoms in the subject, delays progression of a disease in the subject, slows progression of a disease in the subject, or extends survival of the subject. 
     
     
         19 . The method of  claim 1 , wherein the subject in need of treatment with riluzole is a subject with motor neuron disease, spinal muscular atrophy, spinal cord injury, Parkinson's disease, Multiple Sclerosis, Alzheimer's disease, depression, Tourette Syndrome, general anxiety disorders, schizophrenia, or bipolar disorder. 
     
     
         20 . The method of  claim 19 , wherein the subject in need of treatment with riluzole is a subject with amyotrophic lateral sclerosis.