FDA Approval On The Horizon For A New Drug That May Prevent Hearing Loss

A blond medical or scientific researcher or doctor using looking at a clear solution in a laboratory with her Asian female colleague out of focus behind her.

About 20% of the population of the United States or 48 million people experience some degree of hearing loss. It is a significant health concern which ranks as the third most common physical condition behind arthritis and heart disease. The treatments for hearing loss include prevention by avoiding loud noise, and treatment through the use of a hearing aid or cochlear implant. Now, a new kind of treatment is coming to the forefront of hearing impairment treatment, and it is one you can swallow. Research is showing promising results that new drugs may prevent hearing loss in patients undergoing aminoglycoside antibiotic treatment.

An Investigational Drug

A biotech company in Seattle, WA called Oricula Therapeutics is beginning human testing of their investigational drug which is tentatively being called ORC-13661. This research, which started in 2001, sought to understand injury to the receptor cells of the inner ear. It is now poised to begin testing on human subjects. Funding for the trial came from grants by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases. The FDA approval of testing for safety, tolerability, and pharmacokinetics gives the firm the green light to proceed with testing on humans.

Protecting The Ears

The study behind this FDA clearance involves safeguarding the hearing of rats. These creatures received high doses of aminoglycoside antibiotics which are known to impair hearing. Aminoglycoside antibiotics treat bacterial infections. The negative aspect of these drugs is that they may be harmful to the inner ear or the vestibulocochlear nerve which sends hearing and balance information from the inner ear to the brain. When administered the ORC-13661, the rats receive protection from hearing loss caused by aminoglycoside antibiotics.


The mechanism of action of the drug is to protect the hair cells in the inner ear from damage caused by the antibiotics. These sound-sensing cells are crucial to hearing. Oricula’s research with the lateral line hair cells of zebrafish is how the compounds that provide protection came to be. Oricula screened thousands of compounds before finding one compound, ORC-0001, that could protect against the harmful effects of aminoglycosides.

Future Impact

The investigators have high hopes for the future of ORC-13661. They believe that candidates for aminoglycoside antibiotics including cystic fibrosis, immune suppression, endocarditis, multiple drug-resistant TB, and premature newborn infants will benefit from ORC-13661. The new drug will eliminate the lasting hearing loss side effect and open the door for worldwide use of the antibiotic for life-threatening bacterial infections.
The percentage of people with hearing loss is staggering. Adding to these numbers are the people who have suffered permanent hearing loss from an antibiotic that they must have to fight bacterial infections. As hearing problems continue to be a significant health concern in the United States and abroad, research involving the protection of hearing is promising. ORC-13661 could be just the beginning of a line of new drugs that protect hearing from the adverse side effects of medications.

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