scPharmaceuticals Announces Positive Feedback from Two FDA Meetings on Key Long-Term Growth Initiatives - Seite 2

“It is estimated that 12-15 million Americans are aware that they have kidney disease and 50% of patients with CKD do not have a diagnosis of heart failure. With fluid overload being one of the most common complications in CKD, which worsens with disease progression, we believe FUROSCIX could be beneficial to patients with CKD who have worsening symptoms due to fluid overload and are not responding to oral loop diuretics. We plan to advance FUROSCIX as we work towards our goal of introducing a new treatment option to CKD patients with edema as efficiently as possible.”

In August, scPharmaceuticals announced the issuance of U.S. patents covering concentrated formulations of furosemide. The Company has completed initial solubility and stability studies on multiple formulations described in the patent properties, has identified potential product candidates, and commenced Investigational New Drug Application enabling studies. scPharmaceuticals has additional U.S. patent applications pending that cover various methods of use of such or similar formulations of furosemide for treatment of congestion in patients with heart failure and edema in patients with kidney disease. The Company is also pursuing similar patent protection outside of the United States.

FUROSCIX (furosemide injection) 80 mg/10mL for subcutaneous use

FUROSCIX is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

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 FUROSCIX.

IMPORTANT SAFETY INFORMATION

FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide or medical adhesives and in patients with hepatic cirrhosis or ascites.

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital.