Fennec Pharma launches PEDMARK in US

Research Triangle Park: Fennec Pharmaceuticals Inc., a commercial stage specialty pharmaceutical company, has announced the U.S. commercial launch and availability of PEDMARK (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.

"We are proud to announce that PEDMARK is now available to pediatric patients and their physicians who are in need of options to help reduce the risk of cisplatin-induced hearing loss," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "Children who get platinum-based chemotherapy, such as cisplatin, are at risk for permanent hearing loss, a condition that previously could only be managed with cochlear implants and hearing aids. PEDMARK provides the first and only FDA-approved treatment specifically designed to help protect hearing in children and young adults after receiving cisplatin. We look forward to engaging with healthcare providers and supporting patient access to this breakthrough therapy with our assistance program, Fennec HEARS."

PEDMARK was approved by the U.S. Food and Drug Administration (USFDA) in September 2022 based upon safety and efficacy data from two pivotal open-label, randomized Phase 3 trials (Clinical Oncology Group [COG] Protocol ACCL0431 and SIOPEL 6), which compared PEDMARK plus cisplatin-based regimen to cisplatin-based regimens alone for the reduction of cisplatin-induced hearing loss in pediatric patients.