Fennec Pharma gets FDA approval for PEDMARK to reduce cisplatin-induced hearing loss in pediatric patients

FENNEC PHARMACEUTICALS INC.

FDA approved PEDMARK (sodium thiosulfate) for reducing ototoxicity in children aged 1 month+ with localized, non-metastatic solid tumors.
PEDMARK is first and only FDA-approved therapy for this indication; based on two Phase 3 trials (SIOPEL6, COG ACCL0431).
Hearing loss incidence: 21.4% vs 73.3% (COG ACCL0431, p=0.005) and 32.7% vs 63% (SIOPEL6, p=0.002) with PEDMARK plus cisplatin vs cisplatin alone.
Common adverse reactions include vomiting, nausea, decreased hemoglobin, hypernatremia, hypokalemia; monitor electrolytes.
PEDMARK also holds FDA Orphan Drug designation; EU MAA for PEDMARQSI is under EMA evaluation.

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