FDA Approves Expansion for Furosemide Injection to Treat Edema In Patients With CKD

The FDA approved an expanded indication for furosemide injection (Furoscix; scPharmaceuticals, Inc.) to include treating edema in adult patients with chronic kidney disease (CKD), including nephrotic syndrome. The expanded treatment is expected to be available by April 2025. In July 2024, the FDA accepted the supplemental new drug application that sought to expand the indication to include this population.^1,2

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The furosemide injection is currently approved for subcutaneous use as 80 mg/10 mL doses to treat congestion related to fluid overload in adult patients with New York Heart Association (NYHA) class 2 and class 3 heart failure. With this indication, the injection became the first and only FDA-approved subcutaneous loop diuretic that enables the delivery of intravenous (IV)-equivalent diuresis at home via the Furoscix On-Body Infusor. IV equivalence was demonstrated in a clinical study in which the furosemide injection demonstrated about 99.6% bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L, which was similar to patients who received IV furosemide.^2,3

The treatment is not indicated for use in emergency situations or in patients who have acute pulmonary edema. It is contraindicated in patients with anuria or patients with hepatic cirrhosis or ascites with a history of hypersensitivity to furosemide or medial adhesives. This updated indication did not need additional clinical studies, so long as furosemide could demonstrate an adequate pharmacokinetic and pharmacodynamic bridge to the 10 mg/mL listed drug, according to FDA-provided Type D meeting feedback.²

“The potential expansion of the [furosemide injection] indication to include CKD could support a key long-term growth initiative... and an opportunity to improve the lives of [patients with CKD] as [the disease] affects more than 1 in 7 US adults and is characterized by frequent episodes of fluid overload,” John Tucker, CEO of scPharmaceuticals, said in a news release.²

In April 2024, it was announced that the first participant was enrolled in the pivotal pharmacokinetic study of furosemide 80 mg/mL (SCP-111), an investigational, low volume, pH-neutral formulation of furosemide administered via an auto-injector. The auto-injector is being developed as a complement to the FDA-approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility. At this time, Tucker had also noted in a news release the advancement of 2 potential label expansion initiatives with the On-Body Infusor: NYHA class 4 heart failure, which represents about 10% of patients with heart failure; and CKD.⁴

“The development of a low-volume furosemide formulation that can be administered subcutaneously via an auto-injector is a potential long-term growth driver for [us], and we are very pleased to have now enrolled the first participant in this trial,” said Tucker. “We anticipate that this will be an efficient study and look forward to topline data in the third quarter that we believe, if successful, would allow us to submit an sNDA to the FDA by year-end.”⁴

REFERENCES

1. Stock Titan. scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease. News release. March 6, 2025. Accessed March 6, 2025. https://www.stocktitan.net/news/SCPH/sc-pharmaceuticals-announces-fda-approval-of-supplemental-new-drug-tnsu5c1uzzr3.html

2. GlobeNewswire. scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease. News release. July 25, 2024. Accessed March 5, 2025. https://www.globenewswire.com/en/news-release/2024/07/25/2918784/0/en/scPharmaceuticals-Announces-Filing-Acceptance-of-Supplemental-New-Drug-Application-sNDA-Seeking-to-Expand-FUROSCIX-Indication-to-Include-Chronic-Kidney-Disease.html

3. scPharmaceuticals. scPharmaceuticals Announces FDA Approval of FUROSCIX® (furosemide injection), the First and Only Self-administered, Subcutaneous Loop Diuretic for the At-home Treatment of Congestion in Chronic Heart Failure. News release. October 10, 2022. Accessed March 5, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-furoscixr-furosemide

4. scPharmaceuticals. scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection. News release. Accessed March 5, 2025. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-first-participant-enrolled-pivotal