Pedmark® (sodium thiosulfate) is now available to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, nonmetastatic solid tumors.
Pedmark was approved in September 2022 based on data from 2 randomized, controlled, open-label phase 3 trials, SIOPEL 6 (ClinicalTrials.gov Identifier: NCT00652132) and COG ACCL0431 (ClinicalTrials.gov Identifier: NCT00716976), which evaluated the efficacy of sodium thiosulfate in the prevention of cisplatin-induced hearing loss in pediatric patients receiving cisplatin-based chemotherapy.
“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.”
The Company has also established an assistance program called Fennec HEARS™ to provide financial and product access support to patients.
Pedmark is available as a single-dose vial containing 12.5 grams of sodium thiosulfate pentahydrate in 100mL solution (125mg/mL). It is not substitutable with other sodium thiosulfate products.
The safety and efficacy of Pedmark have not been established when administered following cisplatin infusions longer than 6 hours. Pedmark may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Fennec Pharmaceuticals announces commercial availability of Pedmark® (sodium thiosulfate injection) in the United States. News release. Fennec Pharmaceuticals. Accessed October 17, 2022. https://www.globenewswire.com/news-release/2022/10/17/2535408/0/en/Fennec-Pharmaceuticals-Announces-Commercial-Availability-of-PEDMARK-sodium-thiosulfate-injection-in-the-United-States.html