FDA Accepts Furosemide Autoinjector sNDA for Treatment of Edema in Chronic Kidney Disease or Chronic Heart Failure

The FDA accepted the supplemental new drug application (sNDA) seeking approval for Furoscix ReadyFlow autoinjector (SCP-111; Mannkind Corp.) for the treatment of edema in adult patients with chronic kidney disease (CKD) or chronic heart failure (CHF). The application was assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026, according to a news release from the manufacturer.¹

The autoinjector is an investigational alternative to the furosemide (Furoscix; Mannkind Corp.) on-body infusor, which is approved for the same indication the autoinjector is seeking approval for.¹ The original injection was FDA-approved in October 2022 for CHF, and the treatment indication was expanded to include edema in patients with CKD.²

If approved by the FDA, the autoinjector would provide a new administration option for patients with CKD or CHF to treat fluid buildup episodes. After receiving training or counseling from a health care professional, the autoinjector allows for patients to receive treatment in their home rather than in a hospital or office setting. Additionally, this administration method could reduce time from about 5 hours to under 10 seconds, which could significantly improve adherence and manageability of treatment.¹

The sNDA was supported by positive results from an open-label, single-center, single-dose, randomized, 2-way crossover phase 1 trial (NCT06167707) that demonstrated the pharmacokinetics and pharmacodynamics of the furosemide autoinjector. Twenty-one healthy volunteers aged 45 to 80 years were enrolled, all of whom completed the screening, baseline, treatment, and follow-up phases. Participants were randomly assigned to receive either the intravenous (IV) furosemide followed by the autoinjector, or vice versa.^1,3,4

The investigators observed that the furosemide autoinjector demonstrated a bioavailability of approximately 107.3% (90% CI 103.9–110.8), which achieved the 90% confidence interval limit of 80% to 125%. Of note, participants that received the autoinjector had similar urine output, urinary sodium excretion, and urinary potassium excretion at the 6-, 8-, and 12-hour periods compared to IV furosemide. Further, participants reported a median pain score of 0 across all of the assessed time points.³

Regarding adverse events (AEs), the most common with the furosemide autoinjector were localized to the injection site and systemic AEs that were consistent with those reported in the prescribing information for both IV and oral furosemide. The treatment is contraindicated in patients with anuria and in those with a history of hypersensitivity to furosemide, any component of the Furoscix formulation, or medical adhesives.^1,3

“The [furosemide autoinjector] marks a key milestone in expanding patient options and improving care. By delivering treatment in under 10 seconds, the [autoinjector] has the potential to transform how adults with CHF or CKD manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall health care costs,” Michael Castagna, PharmD, CEO at MannKind Corporation, said in a news release. “We are excited about the opportunity to bring this innovation forward and empower patients with greater convenience and control in their treatment journey.”¹

REFERENCES

1. Mannkind. MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow™ Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease. News release. December 1, 2025. Accessed December 3, 2025. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental-new

2. McGovern G. FDA Approves Expansion for Furosemide Injection to Treat Edema In Patients With CKD. Pharmacy Times. March 6, 2025. Accessed December 3, 2025. https://www.pharmacytimes.com/view/fda-approves-expansion-for-furosemide-injection-to-treat-edema-in-patients-with-ckd

3. GlobeNewswire. scPharmaceuticals Announces Positive Topline Study Results for SCP-111 (Furosemide 80 mg/1 mL) Autoinjector. News release. August 12, 2024. Accessed December 3, 2025. https://www.globenewswire.com/news-release/2024/08/12/2928204/0/en/scPharmaceuticals-Announces-Positive-Topline-Study-Results-for-SCP-111-Furosemide-80-mg-1-mL-Autoinjector.html

4. Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers. ClinicalTrials.gov identifier: NCT06167707. Updated June 27, 2024. Accessed December 3, 2025. https://clinicaltrials.gov/study/NCT06167707