USE OF RILUZOLE ORAL DISINTIGRATING TABLETS FOR TREATING DISEASES
Disclosed are methods of treating a disease in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of riluzole, or a pharmaceutically acceptable salt or prodrug thereof, in the form of an oral solid molded fast-dispersing dosage form. Pharmaceutical compositions and kits are also disclosed.
1 . A method of treating an anxiety disorder in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a therapeutically effective amount of riluzole, or a pharmaceutically acceptable salt or prodrug thereof, in the form of an oral solid molded fast-dispersing dosage form in order to provide a reduction of at least 10 VAS points as compared to administration of a placebo.
2 . The method of claim 1 , wherein the dosage of riluzole in the oral solid molded fast dispersing tablet is from 20 to 50 mg.
3 . The method of claim 2 , wherein the dosage of riluzole in the oral solid molded fast dispersing tablet is about 35 mg.
4 . The method of claim 1 , wherein the administration provides a reduction of at least 12 VAS points.
5 . The method of claim 4 , wherein the administration provides a reduction of at least 14 VAS points.
6 . The method of claim 1 , wherein the administration provides a reduction of from about 10 to 25 VAS points.
7 . The method of claim 1 , wherein the administration provides a mean VAS Score of from about 49 to 60.
8 . The method of claim 7 , wherein the administration provides a mean VAS Score of from about 52 to 58.
9 . The method of claim 1 , wherein the disease is SAD.
10 . The method of claim 1 , which provides an enhancement in memory of the patient.
11 . The method of claim 1 , wherein the oral solid molded fast-dispersing dosage form comprises from about 50-70 weight % riluzole, pharmaceutically acceptable salt or prodrug thereof, about 10-30 weight % fish gelatin, about 10-20 weight % of a filler, and 0.1-5.0 weight % of a flavorant.
12 . The method of claim 11 , wherein the filler is mannitol.
13 . The method of claim 1 , wherein the riluzole prodrug has the following formula:
and pharmaceutically acceptable salts thereof, wherein:
R 23 is selected from the group consisting H, CH 3 , CH 2 CH 3 , CH 2 CH 2 CH 3 , CH 2 CCH, CH(CH 3 ) 2 , CH 2 CH(CH 3 ) 2 , CH(CH 3 )CH 2 CH 3 , CH 2 OH, CH 2 OCH 2 Ph, CH 2 CH 2 OCH 2 Ph, CH(OH)CH 3 , CH 2 Ph, CH 2 (cyclohexyl), CH 2 (4-OH-Ph), (CH 2 ) 4 NH 2 , (CH 2 ) 3 NHC(NH 2 )NH, CH 2 (3-indole), CH 2 (5-imidazole), CH 2 CO 2 H, CH 2 CH 2 CO 2 H, CH 2 CONH 2 , and CH 2 CH 2 CONH 2 .
14 . The method of claim 13 , wherein the riluzole prodrug has the following formula:
15 . A kit for treating a disease in a patient, the kit comprising:
(a) a pharmaceutical composition comprising a therapeutically effective amount of riluzole, or a pharmaceutically acceptable salt thereof in the oral solid molded fast dispersing tablet; and
(b) instructions for administering the pharmaceutical composition; wherein the therapeutically effective amount provides a reduction of at least 10 VAS points as compared to administration of a placebo.