FDA approves subcutaneous, self-administered furosemide for congestion in chronic HF
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scPharmaceuticals Inc. announced the FDA approved its self-administered subcutaneous furosemide injection for the treatment of congestion from fluid overload in adults with NYHA II and III chronic HF.
The new formulation of furosemide (Furoscix) 80 mg is the only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via an on-body infuser attached to the patient’s abdomen, according to a press release issued by the company.
The IV equivalence of subcutaneous furosemide was established in a clinical study in which it demonstrated 99.6% bioavailability (90% CI, 94.8-104.8) and 8-hour urine output of 2.7 L, similar compared with patients receiving IV furosemide, according to the release.
Furosemide is not indicated for emergency situations or for patients with acute pulmonary edema, according to the release.
“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,” William T. Abraham, MD, professor of internal medicine (cardiology), physiology and cell biology and College of Medicine Distinguished Professor at The Ohio State University, who is an scPharmaceuticals board member, said in the release. “The FDA’s approval of FUROSCIX is significant and will allow patients to be treated outside of the hospital setting, and I look forward to incorporating it into my own practice as quickly as possible.”
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