The Food and Drug Administration (FDA) has approved Furoscix® (furosemide injection) 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 a pH-neutral formulation of furosemide designed for subcutaneous (SC) administration via a wearable, single-use, pre-programmed on-body infusor for outpatient self-administration. The on-body infusor delivers an 80mg dose of Furoscix, of which 30mg is administered over the first hour followed by 12.5mg per hour for the subsequent 4 hours. 

The treatment is not indicated for emergency situations or in patients with acute pulmonary edema. Furoscix is not for chronic use and should be replaced with oral diuretics as soon as practical.

In patients with NYHA Class II-III congestive heart failure, subcutaneous infusion of Furoscix demonstrated 99.6% bioavailability (90% CI, 94.8-104.8) with a median Tmax of 4 hours relative to 80mg intravenous furosemide (two 40mg bolus doses separated by 120 minutes).

Additionally, in the FREEDOM-HF study (ClinicalTrials.gov Identifier: NCT03458325), the Company evaluated the admission avoidance and overall economic impact associated with management of worsening heart failure using Furoscix outside the hospital in patients initially presenting to the emergency department. Findings from the study showed a highly statistically significant reduction in 30-day heart failure-related costs in patients who received Furoscix compared with the comparator arm.

“Chronic heart failure affects as many as 7.2 million adults in the US. Their congestion often worsens over time, and when oral diuretics start to lose their effectiveness, enhanced diuresis is necessary. Up until now, this level of treatment has only been available in hospitals, clinics or acute care settings, but this FDA approval allows people to self-administer subcutaneous furosemide in the comfort of their home,” said John Tucker, President and CEO of scPharmaceuticals. 

Furoscix is supplied as a single-dose 80mg/10mL prefilled cartridge for subcutaneous infusion co-packaged with 1 on-body infusor. The product is expected to launch in the first quarter of 2023.

References

  1. Update – 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. scPharmaceuticals Inc. October 10, 2022. Accessed October 11, 2022. https://www.globenewswire.com/news-release/2022/10/10/2531118/0/en/UPDATE-scPharmaceuticals-Announces-FDA-Approval-of-FUROSCIX-furosemide-injection-the-First-and-Only-Self-administered-Subcutaneous-Loop-Diuretic-for-the-At-home-Treatment-of-Conges.html
  2. Furoscix. Package insert. scPharmaceuticals Inc.; 2022. Accessed October 11, 2022. https://www.furoscix.com/wp-content/uploads/2022/10/prescribing-information.pdf