FDA approval of Furoscix, the first and only self-administered, subcutaneous loop diuretic for the at-home treatment of congestion in chronic heart failure
scPharmaceuticals Inc. announced that the FDA has approved Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure
Furoscix is not indicated for emergency situations or in patients with acute pulmonary edema. Furoscix Infusor will deliver only an 80-mg dose. Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor.
IV equivalence was established in a clinical study in which Furoscix demonstrated 99.6% bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L which was similar to subjects receiving intravenous furosemide.
Furoscix enables subcutaneous administration at home by the patient or a caregiver with the use of the Furoscix On-Body Infusor. The On-Body Infusor for Furoscix was developed utilizing West Pharmaceutical Services’ proprietary SmartDose On-Body Drug Delivery technology. Once the pre-filled cartridge is inserted into the pre-programmed single-use On-Body Infusor for Furoscix and attached to the abdomen, the device is activated with the press of a button to deliver an 80-mg dose over five hours.
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