FDA Expands Approval of wearable furosomide delvery system for CKD-Related Edema

The US Food and Drug Administration (FDA) has broadened the approval of Furoscix (furosemide injection) to treat edema in patients with chronic kidney disease (CKD), including nephrotic syndrome.

"We are thrilled to announce that the FDA has approved the sNDA for FUROSCIX, expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the FUROSCIX franchise and underscores our commitment to addressing unmet needs of cardiorenal patients," said John Tucker, Chief Executive Officer of scPharmaceuticals. "In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. We are excited to introduce FUROSCIX to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload."

“Expanding the FUROSCIX indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload,” stated Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana (NANI). “Utilizing FUROSCIX can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.”

Indication

FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.

Important safety information

FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.

Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.