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

Company advancing plans to expand the FUROSCIX franchise to include an 80mg/1ml auto-injector as an additional delivery system designed to provide greater flexibility to heart failure patients

Agency confirms no additional clinical data required to pursue label expansion of FUROSCIX into chronic kidney disease (CKD)

BURLINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), 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 the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives.

The Company today announced FDA feedback from a Type C meeting pertaining to the development of an 80mg/1mL auto-injector intended to provide an additional option to the on-body infusor for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization.

The Company expects that an auto-injector, if successfully developed and approved, would reduce manufacturing costs compared to the current on-body infusor and confer environmental advantages. scPharmaceuticals plans to report data from a pivotal pharmacokinetic (PK) study in first half of 2024, and, if successful, targets submitting a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024.

The Company also announced today feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics.

“We are very pleased to have reached alignment with the FDA on the advancement of these two very important long-term growth initiatives for our company,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We believe the development of an auto-injector, designed to administer a subcutaneous injection of our proprietary, concentrated furosemide formulation, represents a new potential treatment alternative that could further increase the appeal of FUROSCIX among both treating physicians and their patients while significantly lowering our costs. We look forward to announcing pivotal PK data and submitting a sNDA next year.”