NKCC2

SCP-111 Autoinjector achieved primary pharmacokinetic and secondary pharmacodynamic endpoints The autoinjector is being developed to deliver a subcutaneous injection of furosemide as an alternative option to the FDA approved FUROSCIX on-body infusor presentation Company targeting Supplemental New Drug Application (sNDA) submission to the FDA by year-end 2024 Aug. 12, 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 positive topline results from the pharmacokinetic (PK) study of SCP-111, an investigational, low volume, pH neutral formulation of furosemide administered via an autoinjector as an alternative to the current on-body infusor used with FUROSCIX. The objectives of the study were to estimate the bioavailability and describe the PK and pharmacodynamics (PD) of SCP-111 (furosemide 80 mg/1 mL) administered as a subcutaneous injection via an autoinjector compared with the equivalent dose of furosemide administered as two 40mg IV injections administered over 1-to-2 minutes, two hours apart and to describe the safety and tolerability of the SCP-111 injection. SCP-111 demonstrated a bioavailability of 107.3% (90% CI: 103.9 - 110.8), achieving the 90% confidence interval limit of 80 to 125 percent Participants that received SCP-111 had similar urine output, urinary sodium excretion and urinary potassium excretion at 6, 8 and 12 hours compared to IV furosemide Participants reported a median pain score of 0 across all time points assessed The most common adverse events with SCP-111 were localized to the injection site and systemic adverse events were consistent with those reported in the prescribing information for intravenous and oral furosemide “With these positive topline data now in-hand, we continue to work towards our targeted submission of an sNDA to the FDA by the end of this year,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “If approved, we believe administration of furosemide via an autoinjector would provide treatment flexibility to cardiologists and heart failure specialists and their patients.” This study was an open-label, single-center, single-dose, randomized, two-way crossover study in twenty-one healthy volunteers, ranging in age from 45 to 80. Each subject completed the screening, baseline, treatment, and follow-up phases. Subjects were randomly assigned in a 1:1 ratio to one of two treatment sequences (IV furosemide followed by SCP-111 via the autoinjector, or vice versa). scPharmaceuticals plans to submit the full data set from this study for future presentation at a medical meeting or publication. scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com. The content above comes from the network. if any infringement, please contact us to modify.