scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

FUROSCIX Auto-injector being developed as a complement to the FUROSCIX On-body Infusor

Company anticipates topline data in Q3 2024, followed by a Supplemental New Drug Application (sNDA) by year-end 2024, if successful

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility. If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.

“The development of a low volume furosemide formulation that can be administered subcutaneously via an auto-injector is a potential long-term growth driver for our Company, and we are very pleased to have now enrolled the first participant in this trial,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We anticipate that this will be an efficient study and look forward to topline data in the third quarter that we believe, if successful, would allow us to submit an sNDA to the FDA by year-end.”

“In parallel, we are also advancing two important potential label expansion initiatives with our current On-body Infusor, including NYHA Class IV heart failure, representing approximately 10% of all heart failure patients, and chronic kidney disease, an estimated additional $3 billion market opportunity. Together, we believe these activities, if successful, will allow us to reach more patients in need while generating meaningful and enduring value for our shareholders,” Mr. Tucker concluded.

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.

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