First subcutaneous furosemide approved by US Food and Drug Administration

By Dr. Oliver Jones

Key points:

  • scPharmaceuticals claims first-ever approval for subcutaneous furosemide formulation in US markets
  • Novel formulation offers promise for expanded community treatment of heart failure and hospital admission avoidance

scPharmaceuticals announced this week that the US Food and Drug Administration had approved its first-in-class subcutaneous furosemide injection Furoscix®, delivered via an “on-body infusor”.

The novel formulation delivers 80mg furosemide in a 10mL cartridge, and gained approval for treatment of congestion or fluid overload in New York Heart Association Class II/III chronic heart failure – though not in emergencies or acute pulmonary oedema.

In their press release, scPharmaceuticals claimed 99.6% bioavailability and average 8-hour urine output of 2.7 litres, based on clinical studies.

Professor William T. Abraham, M.D., an scPharmaceuticals board member, argued that “This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of intravenous diuretics, which typically requires admission to the hospital.”

Commercial launch is planned for Q1 2023 in US markets.

Read more at the scPharmaceuticals press release: