- The U.S. Food and Drug Administration (FDA) approved scPharmaceuticals ( NASDAQ: SCPH ) Furoscix's to treat congestion due to fluid overload in adults with New York Heart Association Class 2/3 chronic heart failure.
- Furoscix, a proprietary formulation of furosemide delivered via an On-Body Infusor, is the first and only FDA-approved subcutaneous loop diuretic which delivers IV equivalent diuresis at home via the Furoscix Infusor, the company said in an Oct. 10 press release.
- In a study Furoscix showed 99.6% bioavailability and produced similar diuresis and natriuresis compared to intravenous furosemide, scPharmaceuticals noted.
- Furoscix is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of the drug, the company added.
- The commercial launch is planned for Q1 2023 by scPharmaceuticals.
- In a separate release, the company said it signed an agreement for a $100M debt facility .
- SCPH -6.83% to $4.64 premarket
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FDA approves scPharmaceuticals Furoscix to treat congestion in heart failure