Hormone treatment for age-related hearing loss-presbycusis

Patent metadata

Field	Value
Publication number	US-10342806-B2
Application number	US-201615196878-A
Country	US
Kind code	B2
Filing date	Jun 29, 2016
Priority date	Feb 10, 2014
Publication date	Jul 9, 2019
Grant date	Jul 9, 2019

Abstract

Permanent hearing loss or deafness affects about 15% of people worldwide, about 40 million in the US alone. There are currently no FDA-approved drugs on the market in the US, or anywhere in the world that prevent, treat or reverse permanent hearing loss or deafness. Age-related hearing loss (ARHL) is one of the most common forms of permanent hearing loss and deafness. ARHL is the #1 neurodegenerative disorder, #1 communication disorder, and 1 of the top 3 chronic medical conditions (along with arthritis & cardiovascular diseases) of our aged population. The incidence of ARHL is increasing due to the “Baby Boomers” reaching old age, and cumulative effects of lifetime noise exposure, and widespread use of chemotherapeutic and antibiotic drugs, which are ototoxic, or have ototoxic side effects. A new drug is disclosed to prevent or slow the progression of ARHL, based upon natural, existing FDA-approved compounds that are on the market to treat other non-ARHL biomedical problems. When given in the proper dosage the compounds have few, if any side effects, and initial evidence supports the effectiveness of the drug from in vitro experiments, and in vivo studies of aging mice, indicating is usefulness in preventing/treating one of the most pervasive forms of permanent hearing loss.

First claim

What is claimed is:

1. A method of treating an age-related hearing disorder, comprising:
administering a therapeutically effective amount of a composition to a patient suffering from the age-related hearing disorder;
wherein the composition comprises aldosterone, ammonium chloride, and an anti-inflammatory drug;
wherein the aldosterone is administered at 0.004 mg/kg/day to 0.04 mg/kg/day;
wherein the ammonium chloride administered at 8 g/day to about 12 g/day, and
wherein the anti-inflammatory drug is administered at 2.5 mg/kg/day to 10 mg/kg/day.

2. The method of claim 1 , wherein the age-related hearing disorder is presbycusis.

3. The method of claim 1 , wherein the anti-inflammatory drug is non-steroidal.

4. The method of claim 3 , wherein the non-steroidal anti-inflammatory drug is naproxen, salicylic acid, ibuprofen, diflurophenyl salicylate derivatives, salicylsalicylic acid, sodium salicylate, salicyclamide, sodium thiosalicylate, choline salicylate, magnesium salicylate, and choline-magnesium salicylate, phenylbutazone, oxyphenylbutazone, antipyrine, aminopyrine, apazone, indomethacin, sulindac, phenacetin, acetaminophen, mefenamic, meclofenamic, flufenamic, mefenomic, ectofenamic, tolmectin, flurbioprofen, fenoprofen, ketoprofen, fenbufen, pirprofen, oxaprozin, or indoprofen.

5. A composition for treating chronic age-related hearing loss comprising:
a therapeutically effective amount of the composition to give to a patient suffering from age-related hearing loss comprising aldosterone, ammonium chloride and a non-steroidal anti-inflammatory drug;
wherein the aldosterone is at a dose of 0.004 mg/kg/day to 0.04 mg/kg/day;
wherein the ammonium chloride is at a dose of 8 g/day to 12 g/day;
wherein the non-steroidal anti-inflammatory drug is at a dose of 2.5 mg/kg/day to 10 mg/kg/day.

6. The composition of claim 5 , wherein the non-steroidal anti-inflammatory drug is naproxen, salicylic acid, ibuprofen, diflurophenyl salicylate derivatives, salicylsalicylic acid, sodium salicylate, salicyclamide, sodium thiosalicylate, choline salicylate, magnesium salicylate, and choline-magnesium salicylate, phenylbutazone, oxyphenylbutazone, antipyrine, aminopyrine, apazone, indomethacin, sulindac, phenacetin, acetaminophen, mefenamic, meclofenamic, flufenamic, mefenomic, ectofenamic, tolmectin, flurbioprofen, fenoprofen, ketoprofen, fenbufen, pirprofen, oxaprozin, or indoprofen.

7. The composition of claim 6 , wherein the non-steroidal anti-inflammatory drug is aspirin.

8. The composition of claim 7 , wherein the aspirin is at a dose of about 5 to about 10 mg/kg/day, 30 to 60 mg/day, 60 to about 100 mg/day, or 75 mg/day.

9. The composition of claim 6 , wherein the non-steroidal anti-inflammatory drug is ibuprofen.

10. The composition of claim 9 , wherein the ibuprofen is at a dose of about 2.5 mg/kg/day, about 0.4 g/day to about 1.2 g/day, or 100 mg/day.

11. The composition of claim 6 , wherein the non-steroidal anti-inflammatory drug is naproxen.

12. The composition of claim 11 , wherein the naproxen is at a dose of 5 to 10 mg/kg/day.

Assignees

• Frisina Robert Dana
• Walton Joseph Paul
• Ding Bo
• Zhu Xiaoxia
• Univ South Florida

Inventors

• Frisina Robert Dana
• Walton Joseph Paul
• Ding Bo
• Zhu Xiaoxia

Classifications

• A61K31/573 Primary

  substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone · CPC title

• A61K33/02

  Ammonia; Compounds thereof · CPC title

• A61K45/06

  Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca · CPC title

• A61K31/616

  by carboxylic acids, e.g. acetylsalicylic acid · CPC title

• A61K2300/00

  Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00 · CPC title