(+)-azasetron for use in the treatment of ear disorders
Disclosed is a method for treating ear disorders, including the administration of (+)-azasetron, or a pharmaceutically acceptable salt and/or solvate thereof.
1. A method of treatment of a cochlear disease, disorder or condition in a patient afflicted with a cochlear disease, disorder or condition, wherein said method comprises the administration to the patient of a composition comprising
(+)-azasetron, of Formula (R)-I:
or a pharmaceutically acceptable salt and/or solvate thereof;
and at least one pharmaceutically acceptable excipient,
wherein said cochlear disease, disorder or condition is sensorineural hearing loss or cochlear tinnitus.
2. The method according to claim 1 , wherein the pharmaceutically acceptable salt is selected from the group consisting of: (+)-azasetron besylate, (+)-azasetron malate and (+)-azasetron hydrochloride.
3. The method according to claim 1 , wherein the composition is administered at a dose of free-base (+)-azasetron, or a pharmaceutically acceptable salt and/or solvate thereof, ranging from about 0.01 mg/kg to about 100 mg/kg of body weight per day.
4. The method according to claim 1 , wherein the composition is administered systemically or locally.
5. The method according to claim 4 , wherein the composition is administered directly in the ear.
6. The method according to claim 5 , wherein the composition is loaded on a device to be inserted into the cochlear duct or any other part of the cochlea.
7. The method according to claim 1 , wherein the composition is administered orally.
8. The method according to claim 1 , wherein said sensorineural hearing loss is ototoxic compound-induced sensorineural hearing loss.
9. The method according to claim 1 , wherein said sensorineural hearing loss is platinum-induced sensorineural hearing loss.
10. The method according to claim 1 , wherein said sensorineural hearing loss is cisplatin-induced sensorineural hearing loss.
11. The method according to claim 1 , wherein the patient is diagnosed with cancer.
12. The method according to claim 1 , wherein the patient is diagnosed with cancer and is receiving platinum-based chemotherapy.
13. The method according to claim 1 , wherein the patient is diagnosed with cancer and is receiving cisplatin, carboplatin, oxaliplatin or a combination thereof.
14. The method according to claim 1 , wherein the patient is diagnosed with cancer and wherein the composition is administered during and/or after platinum-based chemotherapy.
15. The method according to claim 1 , wherein the patient is diagnosed with cancer and wherein the composition is administered during and/or after cisplatin-, carboplatin- or oxaliplatin-based chemotherapy or a combination thereof.
16. The method according to claim 1 , wherein said sensorineural hearing loss is sudden sensorineural hearing loss or noise-induced sensorineural hearing loss.
17. The method according to claim 16 , wherein said sudden sensorineural hearing loss is idiopathic sudden sensorineural hearing loss.
18. The method according to claim 1 , wherein the composition is an immediate release composition or a sustained release composition.
19. The method according to claim 1 , wherein the composition is an orodispersible composition.
20. The method according to claim 1 , wherein the composition comprises at least a 90:10 w/w mixture of (+)-azasetron of Formula (R)-I:(−)-azasetron.