IP Library Granted Patent US 10,342,806
Granted Patent B2
US 10,342,806 · App. 15/196,878 · Granted Jul 9, 2019

Hormone treatment for age-related hearing loss-presbycusis

Inventors: Robert Dana Frisina (Tampa, FL); Joseph Paul Walton (Tampa, FL); Bo Ding (Tampa, FL); Xiaoxia Zhu (Tampa, FL)
Assignee: University of South Florida
A61K31/573A61K31/192A61K31/616A61K33/02A61K45/06
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Quick Facts
Patent No.
US 10,342,806
App. No.
15/196,878
Granted
Jul 9, 2019
Kind
B2
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.

Claims (21)

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.

Assignments (2)
CONFIRMATORY LICENSE Recorded Aug 9, 2016
From: UNIVERSITY OF SOUTH FLORIDA
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 039631/0832 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2016
From: FRISINA, ROBERT DANA; WALTON, JOSEPH PAUL; DING, BO; ZHU, XIAOXIA
To: UNIVERSITY OF SOUTH FLORIDA
Reel/Frame 039149/0341 →
Continuity (3)
Continuation PCTUS2015015216 · Feb 10, 2015
Provisional Application 61937699 · Feb 10, 2014
Related Publication 20160375038A1 · Dec 29, 2016