SUBLINGUAL FORMULATION OF RILUZOLE
Disclosed is sublingual administration of riluzole. In particular, a method for treating a neuropsychiatric disorder or symptom by administering a sublingual formulation of riluzole is provided. In addition, a method of relieving or reducing oral pain using the sublingual formulation of riluzole is disclosed.
1 - 30 . (canceled)
31 . A method of treating ataxia in a patient in need thereof, comprising administering to the patient a sublingual formulation comprising an effective amount of riluzole or a pharmaceutically acceptable salt thereof, a tablet binder comprising gelatin, a bulking agent comprising mannitol or sorbitol, and a solubilizing agent comprising docusate sodium.
32 . The method of claim 31 , wherein the ataxia is cerebellar ataxia.
33 . The method of claim 31 , wherein the ataxia is hereditary ataxia.
34 . The method of claim 31 , wherein the sublingual formulation further comprises a flavoring agent, a sweetener, or a combination thereof.
35 . The method of claim 34 , wherein the sweetener comprises sucralose.
36 . The method of claim 31 , wherein the sublingual formulation is a lyophilized, tableted pharmaceutical composition that provides sublingual absorption of riluzole.
37 . The method of claim 31 , wherein the sublingual formulation is capable of providing an AUC at a dose of 35 mg 10 of from 110% to 180% of the AUC of an oral tablet formulation at a dose of 50 mg, said AUC being measured at 0.5 hours, 1 hour or 2 hours after administration as measured in accordance with Example 6.
38 . The method of claim 31 , wherein the sublingual formulation is capable of providing a higher AUC ratio than the predicted AUC ratio of an oral tablet formulation comprising 50 mg of riluzole, said AUC being measured at 0.5 hours, 1 hour or 2 hours as measured in accordance with Example 6.
39 . The method of claim 31 , wherein the effective amount of riluzole for the sublingual formulation to achieve a therapeutic dose is less than that of orally administered riluzole.
40 . The method of claim 31 , wherein an effective dose of the sublingual formulation of the riluzole is about 1 to 95% of that of the orally administered riluzole.
41 . The method of claim 31 , wherein the sublingual formulation of riluzole is associated with minimal or no oral numbness, wherein said minimal oral numbness dissipates in less than 30 minutes.
42 . The method of claim 31 , wherein the sublingual formulation delivers an exposure (AUC) that is the same as that delivered by a higher orally administered dose of riluzole.
43 . The method of claim 31 , wherein the liver function abnormalities side effects of riluzole are attenuated relative to those which are associated with the orally administered riluzole.
44 . The method of claim 31 , wherein the sublingual formulation is dosed at or below about 50 mg/day.
45 . The method of claim 31 , wherein the sublingual formulation is dosed at or below about 35 mg/day.
46 . The method of claim 31 , wherein the sublingual formulation is dosed at or below about 17.5 mg/day.
47 . The method of claim 31 , wherein the sublingual formulation is dosed at or below about 10 mg/day.