The New Drug Application (NDA) for Ryanodex (dantrolene sodium for injectable suspension) has been resubmitted to the Food and Drug Administration (FDA) by Eagle Pharmaceuticals for the treatment of exertional heat stroke.
In July 2017, Eagle had received a Complete Response Letter (CRL) from the FDA stating that an additional clinical trial would be needed prior to approval for the indication. The resubmitted NDA includes data collected from 41 patients treated for exertional heat stroke during the Hajj pilgrimage.
“We are pleased to have resubmitted our NDA for [exertional heat stroke] and we look forward to continuing to work with the FDA over the course of its review,” stated Scott Tarriff, Chief Executive Officer. The Company noted that for this type of resubmission a Prescription Drug User Fee Act (PDUFA) date of 6 months is expected; the NDA for exertional heat stroke has received Orphan Drug, Fast Track, and Priority Review designations.
Currently, there is no approved pharmacological treatment for exertional heat stroke; treatment is limited to body cooling by physical methods (eg, water immersion, ice packs, water misting), and supportive measures including intravenous fluids and respiratory support. If approved, Ryanodex would become the first drug therapy for this life-threatening medical emergency.
Ryanodex, a skeletal muscle relaxant, is currently indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
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