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

In this article:
  • The FDA has approved scPharmaceuticals Inc's (NASDAQ: 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.

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