FDA Clears Testing of Drug to Prevent Antibiotic-Related Hearing Loss A Seattle-based biotech startup firm can begin volunteer human testing on a drug that may prevent hearing loss in people exposed to aminoglycoside antibiotics. The U.S. Food and Drug Administration (FDA) cleared Oricula Therapeutics to test the safety, tolerability and pharmacokinetics of its investigational drug ORC-13661, found to provide significant ... News in Brief
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News in Brief  |   May 01, 2018
FDA Clears Testing of Drug to Prevent Antibiotic-Related Hearing Loss
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Hearing Disorders / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   May 01, 2018
FDA Clears Testing of Drug to Prevent Antibiotic-Related Hearing Loss
The ASHA Leader, May 2018, Vol. 23, 11. doi:10.1044/leader.NIB4.23052018.11
The ASHA Leader, May 2018, Vol. 23, 11. doi:10.1044/leader.NIB4.23052018.11
A Seattle-based biotech startup firm can begin volunteer human testing on a drug that may prevent hearing loss in people exposed to aminoglycoside antibiotics.
The U.S. Food and Drug Administration (FDA) cleared Oricula Therapeutics to test the safety, tolerability and pharmacokinetics of its investigational drug ORC-13661, found to provide significant hearing protection in rats exposed to the hearing-damaging antibiotics.
The compound protects sound-sensing hair cells from damage. If the clinical trials are successful, ORC-13661 could become the first FDA-approved medicine to prevent hearing loss for patients taking aminoglycosides, used for cystic fibrosis, immune suppression, endocarditis, nontuberculous mycobacteria, multiple-drug-resistant tuberculosis and in premature newborns.
Funding for the preclinical development was obtained through grants from the National Institutes of Health.
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May 2018
Volume 23, Issue 5