Sodium Thiosulfate: Pediatric First Approval

Sodium thiosulfate has been used in the treatment of calcium poisoning and cyanide detoxification. However Sodium thiosulfate (Pedmark®), a chemoprotectant/antioxidant developed by Fennec Pharmaceuticals, was first approved in September 2022 in the US. It is used to reduce the risk of cisplatin-related ototoxicity in paediatric patients with localised non-metastatic solid tumours aged 1 month and older.

Sodium thiosulfate is under regulatory review in the European Union for the prevention of ototoxicity due to cisplatin chemotherapy in patients with localised non-metastatic solid tumours aged 1 month to less than 18 years. This is the first time that Sodium thiosulfate has been approved in paediatrics to reduce the risk of cisplatin-related ototoxicity in paediatric patients.

In addition, intravenous Sodium thiosulfate is used to treat calciphylaxis. Calcinosis cutis is the deposition of calcium salts in the skin. The atrophic form is the most common and usually occurs during chronic inflammatory processes associated with collagen disease. In a study using five patients with dermatodystrophic calciphylaxis, six cycles of sodium thiosulfate were administered intravenously for at least five consecutive days per month at single doses of 12.5 g and 25.0 g, respectively. Although it was not possible to determine whether there was a reduction in the number of calcified lesions, the condition stabilised. Intravenous sodium thiosulfate can inhibit the development of cutaneous calcinosis.

Studies have shown that Sodium thiosulfate also shows preliminary therapeutic promise in critical diseases such as neuronal ischaemia, diabetes, heart failure and acute lung injury.

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