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MannKind Receives FDA Approval Of Its Furoscix ReadyFlow For Treatment Of Edema In Adults With Heart Failure Or Chronic Kidney Disease
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Furoscix ReadyFlow is an at-home treatment option designed to help adults with heart failure or chronic kidney disease address fluid overload earlier, before worsening symptoms may lead to emergency department visits, hospitalization, or readmission. As the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure (based on comparisons of AUC and PD endpoints), Furoscix ReadyFlow provides a full 80 mg/mL dose in a simple, patient-friendly format administered in under 10 seconds. The therapy is absorbed into the bloodstream, and symptom relief may begin in an hour or less. Together, these attributes may help expand opportunities for earlier intervention and extend IV-equivalent furosemide exposure beyond the hospital for appropriate patients across outpatient, post-discharge and home-based care settings.

The FDA approval is supported by positive clinical data demonstrating that Furoscix ReadyFlow achieved its primary pharmacokinetic endpoint. The study also demonstrated equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared to IV furosemide. Furoscix ReadyFlow was generally well tolerated, with a safety profile consistent with known effects of oral and intravenous furosemide.

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