Fennec Pharma Receives FDA Approval of Pedmark
The FDA approved Fennec Pharma’s Pedmark (sodium thiosulfate injection) for reducing the risk of hearing loss associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors.
The agency had previously declined to grant approval in August 2020 and again in November 2021 because of unresolved manufacturing issues.
The approval was supported by positive results from two clinical trials. In one study, the incidence of hearing loss was 39 percent in patients who received cisplatin-based chemotherapy with sodium thiosulfate, compared with 68 percent in the treatment arm that received cisplatin alone.
“Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss,” said David R. Freyer, DO, MS, Primary Investigator, COG ACCL0431, and Director of the Survivorship & Supportive Care Program, Cancer and Blood Disease Institute, Children’s Hospital Los Angeles. “As a physician focused in pediatric cancer for many years, and a primary investigator in the pivotal Pedmark phase 3 Clinical Oncology Group (COG) trial, the FDA approval of Pedmark addresses an enormous unmet need and for many children and young adults, has the potential to greatly improve everyday activities for these patients.”
Pedmark is supplied 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.
Fennec Pharmaceuticals
Fennec Pharmaceuticals, Inc., (NASDAQ: FENC; TSX: FRX) is a specialty pharmaceutical company focused on the development of PEDMARK™ (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients. STS has received Orphan Drug Designation in the US in this setting.
September 22, 2022
