scPharmaceuticals Gets Heart Failure Drug Approved

FDA has approved scPharmaceuticals’ Furoscix (furosemide injection), described as a proprietary formulation of furosemide delivered via an on-body infusor for treating congestion due to fluid overload in adults with New York Heart Association Class 2/3 chronic heart failure. The company says Furoscix is the first FDA-approved subcutaneous loop diuretic that delivers intravenous (IV)-equivalent diuresis at home using an infusor. It notes that the product is not indicated for emergency situations or in patients with acute pulmonary edema.

“IV equivalence was established in a clinical study in which Furoscix demonstrated 99.6% bioavailability (90% CI: 94.8%-104.8%) and eight-hour urine output of 2.7 L which was similar to subjects receiving intravenous furosemide,” scPharmaceuticals says. The on-body infusor was developed using West Pharmaceutical Services’ proprietary SmartDose On-Body Drug Delivery technology, it adds.