FDA Approves scPharmaceuticals' Self-Administered Med For Congestion in Chronic Heart Failure

The FDA has approved scPharmaceuticals Inc's SCPH Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for congestion due to fluid overload in heart failure patients.
Furoscix is not indicated for emergencies or in patients with acute pulmonary edema. Furoscix Infusor will deliver only an 80-mg dose.
The company says Furoscix is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the Furoscix Infusor.
Related: scPharma's Furoscix Can Potentially Cut Hospital Admission/Readmission Costs For Heart Failure Patients.
"We are preparing to optimize commercialization efforts to offer FUROSCIX to patients in the first quarter of next year to drive rapid patient adoption to meet the needs of the $5.9 billion addressable market in the U.S," said John Tucker, President, and CEO.
Concurrently, scPharmaceuticals secured a $100 million secured debt facility from Oaktree Capital Management, L.P.
The company will use the funds and cash on hand to repay indebtedness and execute the launch of Furoscix.
Price Action: SCPH shares are down 7.23% at $4.62 during the premarket session on the last check Monday.