Use of gaboxadol in the treatment of tinnitus
Methods of treating tinnitus with gaboxadol or a pharmaceutically acceptable salt thereof are provided. Also provided are therapeutic compositions that may be used to improve one or more symptoms of tinnitus. Methods of treating acute sensorineural hearing loss or Meniere's disease with gaboxadol or a pharmaceutically acceptable salt thereof are provided. Also provided are therapeutic compositions that may be used to improve one or more symptoms of acute sensorineural hearing loss or Meniere's disease.
1. A method of treating acute sensorineural hearing loss comprising administering to a patient in need thereof about 0.05 mg to about 30 mg gaboxadol or a pharmaceutically acceptable salt thereof, wherein the method provides improvement in one or more symptoms of acute sensorineural hearing loss in the patient and the improvement is provided for more than 6 hours after administration.
2. The method of claim 1 , wherein the patient is administered a composition comprising about 1 mg to about 15 mg gaboxadol or a pharmaceutically acceptable salt thereof.
3. The method of claim 1 , wherein the patient is administered a composition comprising about 1 mg to about 10 mg gaboxadol or a pharmaceutically acceptable salt thereof.
4. The method of claim 1 , wherein the patient is administered a composition comprising about 1 mg to about 5 mg gaboxadol or a pharmaceutically acceptable salt thereof.
5. The method of claim 1 , wherein the in vivo plasma profile of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is reduced by more than 50%.
6. The method of claim 1 , wherein the AUC 6-12 of the patient 6 hours after administration of the gaboxadol or pharmaceutically acceptable salt thereof is less than 75% of the administered dose.
7. The method of claim 1 , wherein the method provides improvement in at least one symptom selected from the group consisting of hearing loss, aural fullness and tinnitus.
8. The method of claim 1 , wherein the method provides improvement in the patient for more than 8 hours.
9. The method of claim 1 , wherein the composition provides improvement in the patient for at least 12 hours.
10. The method of claim 1 , further comprising administering from about 1 mg to about 30 mg clobazam or a pharmaceutically acceptable salt thereof to the patient.
11. The method of claim 10 , wherein the amount of clobazam or a pharmaceutically acceptable salt thereof is 5 mg to 20 mg.
12. The method of claim 11 , wherein the amount of clobazam or a pharmaceutically acceptable salt thereof is 10 mg.
13. A method of treating acute sensorineural hearing loss comprising administering to a patient in need thereof gaboxadol or a pharmaceutically acceptable salt thereof wherein the method provides an in vivo plasma profile comprising a C max less than about 400 ng/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.
14. A method of treating acute sensorineural hearing loss comprising administering to a patient in need thereof gaboxadol or a pharmaceutically acceptable salt thereof wherein the method provides an in vivo plasma profile comprising a AUC 6-12 of less than about 900 ng·hr/ml and wherein the method provides improvement in the patient for more than 6 hours after administration of the gaboxadol or a pharmaceutically acceptable salt thereof.
15. The method of claim 1 wherein the method provides improvement in the patient for more than a day after administration.