FDA clears first at-home option for IV-equivalent diuresis

FDA has approved Furoscix ReadyFlow (furosemide injection) for the treatment of edema in adults with heart failure or chronic kidney disease. The ready-to-use autoinjector delivers 80 mg of subcutaneous furosemide in less than 10 seconds, with systemic exposure equivalent to IV administration. The product is intended to replace oral diuretics temporarily, as directed by a clinician.

Approval was supported by an open-label, randomized, two-period crossover study involving 21 healthy adults aged 45 to 80 years. Participants received Furoscix ReadyFlow and an equivalent 80-mg IV furosemide regimen—two 40-mg injections administered 2 hours apart—in randomized sequence.

The autoinjector achieved 107.3% bioavailability compared with IV furosemide; the 90% confidence interval of 103.9% to 110.8% fell within the prespecified bioequivalence range of 80% to 125%. Urine output and urinary sodium and potassium excretion were also similar between treatments at 6, 8, and 12 hours.

The treatment was generally well tolerated. Participants reported a median pain score of zero at all assessed time points. The most common adverse events were localized injection-site reactions, while systemic events were consistent with the established safety profile of furosemide.

“An at-home option that delivers similar IV-equivalent furosemide exposure through a simple autoinjector gives clinicians an important new tool to intervene as soon as signs and symptoms of fluid overload appear,” said Hunter Champion, MD, PhD, of Emory University Healthcare Network.

Source: Mannkind. (2026 Jul 24). MannKind announces FDA approval of Furoscix ReadyFlow™, the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure or chronic kidney disease