Wearable single use subcutaneous Furosemide Delivery System Under Review for Use in CKD Patients

The US Food and Drug Administration (FDA) has accepted supplemental New Drug Application for review of a pH-neutral formulation of furosemide, a loop diuretic, designed for subcutaneous (SC) administration via a , single-use wearable, pre-programmed on-body infusor for outpatient self-administration. This will expand the approval of furosemide injection to include treatment of edema due to fluid overload in patients with chronic kidney disease.

Furoscix® is a formulation of furosemide, a loop diuretic, designed for subcutaneous (SC) administration and is supplied as a single-dose 80mg/10mL prefilled cartridge for SC infusion co-packaged with 1 on-body infusor. The product is not intended for chronic use and should be replaced with oral diuretics as soon as practical.

 The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.

In Type D meeting feedback provided by the FDA last year, the agency confirmed that no additional clinical studies would be needed to expand the indication, provided that the Company is able to demonstrate an adequate pharmacokinetic (PK) and pharmacodynamic (PD) bridge to the listed drug, furosemide injection, 10 mg/mL.

“The potential expansion of the FUROSCIX indication to include CKD could support a key long-term growth initiative for our Company, and an opportunity to improve the lives of CKD patients as CKD affects more than 1 in 7 U.S. adults and is characterized by frequent episodes of fluid overload.1” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We look forward to the review of our application by the FDA and are preparing to deploy additional commercial resources, if our sNDA is approved, to efficiently address what we estimate to be a $3 billion addressable market.”

FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use

FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX.