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# FDA Grants Fennec Pharma Fast Track for Ototoxicity Drug
- URL: https://www.fdaweb.com/fda-grants-fennec-pharma-fast-track-for-ototoxicity-drug/
- Published: 2018-03-21T12:00:00.000Z
- Updated: 2026-09-14T23:54:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141037

FDA has granted Fennec Pharmaceuticals a fast track designation for Pedmark (sodium thiosulfate) for preventing cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma. There are currently no drugs approved in the U.S. for the condition, according to the company.

The drug has been studied in two Phase 3 studies for survival and ototoxicity reduction, Fennec says. Data showed that the addition of sodium thiosulfate significantly reduces the incidence of cisplatin-induced hearing loss without any evidence of tumor protection, it says.