If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds
MannKind Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted the sNDA seeking approval for FUROSCIX ReadyFlow Autoinjector (SCP-111), developed to deliver a subcutaneous furosemide injection in under 10 seconds as an investigational alternative to the FDA-approved FUROSCIX (furosemide) On-body Infusor for treatment of edema in adult patients with chronic heart failure (CHF) or chronic kidney disease (CKD). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.
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“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care. By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs,” said Michael Castagna, PharmD, Chief Executive Officer at MannKind Corporation. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”
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If approved, FUROSCIX ReadyFlow Autoinjector would provide a new option for patients with CHF or CKD to manage fluid buildup episodes from the convenience of their home rather than in a hospital setting. The FDA-approved FUROSCIX On-body Infusor was approved for adult patients with edema in chronic heart failure in 2022 and in chronic kidney disease in 2025. The ReadyFlow Autoinjector would reduce administration time from five hours to under 10 seconds.
The sNDA is supported by positive study results announced in August 2024. Furosemide via the ReadyFlow Autoinjector demonstrated a bioavailability of 107.3% (90% CI: 103.9 – 110.8), achieving the 90% confidence interval limit of 80 to 125 percent. Additionally, participants who utilized ReadyFlow Autoinjector had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8, and 12 hours compared to IV furosemide, and was generally well tolerated with respect to injection site pain.
The study was an open-label, single-center, single-dose, randomized, two-way crossover study in 21 healthy volunteers, ranging in age from 45 to 80. Each subject completed the screening, baseline, treatment, and follow-up phases. Subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences (IV furosemide followed by furosemide via the ReadyFlow Autoinjector, or vice versa).
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Source- GlobeNewswire
