FDA Approves Pedmark for Cisplatin Ototoxicity

FDA has approved Fennec Pharmaceuticals’ Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month and older with localized non-metastatic solid tumors. An agency notice says the drug’s efficacy was evaluated in two multi-center open-label trials in pediatric patients undergoing treatment with cisplatin-based chemotherapy for cancer.

The notice says the most common adverse reactions in the two trials were vomiting, nausea, decreased hemoglobin, hypernatremia, and hypokalemia.

Pedmark is administered as an intravenous infusion over 15 minutes following cisplatin infusions that are one to six hours long.

The FDA review used the Assessment Aid, a voluntary submission from the applicant to facilitate the agency’s assessment. Pedmark was granted Orphan Drug designation by FDA, the notice says.