FDA Approves Self-administered, SubQ Furosemide Preparation

October 12, 2022

The US Food and Drug Administration (FDA) has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with chronic heart failure (HF) and volume overload, the company has announced.

The product is indicated for use with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use subcutaneous administration device, which affixes to the abdomen.

The infuser is loaded by the patient or caregiver with a prefilled cartridge and is programmed to deliver Furoscix 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg, scPharmaceuticals said in a press release on the drug approval.

Furosemide, a loop diuretic and one of the world's most frequently used drugs, is conventionally given intravenously in the hospital or orally on an outpatient basis.

The company describes its furosemide preparation, used with the infuser, as "the first and only FDA-approved subcutaneous loop diuretic that delivers IV-equivalent diuresis at home." It has been shown to "produce similar diuresis and natriuresis compared to intravenous furosemide."

"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 IV diuretics, which typically requires admission to the hospital," William T. Abraham, MD, says in the press release.

The FDA approval "is significant and will allow patients to be treated outside of the hospital setting," said Abraham, of Ohio State University, Columbus, and an scPharmaceuticals board member, in the release.

The Furoscix indication doesn't cover emergent use or use in acute pulmonary edema, nor is it meant to be used chronically "and should be replaced with oral diuretics as soon as practical," the company states.

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