Medicine Compliance Aid Stability
genericAmdipharm Mercury Co Ltd
Lactation Safety Information
FuroscixChronic heart failure in patients with oedema - micropump patch formulation
Development and Regulatory status
Trial or other data
Nov 15: scPharmaceuticals announce top-line pharmacokinetics and pharmacodynamics results from a pivotal registrational PII/III. scPharmaceuticals initiated the randomised pivotal trial in April 2015 to assess the pharmacokinetics and bioavailability of single doses of its subcutaneous furosemide product, compared to intravenous bolus doses of furosemide USP, in patients with chronic heart failure (NCT02329834; scP-01-002). The trial enrolled 16 patients in the US, and was completed in October 2015. The company had received inputs from the US FDA, through in-person meetings and correspondence, for conduct of the trial .
Oct 14: scPharmaceuticals complete a PII study that assessed the pharmacodynamics and pharmacokinetics of subcutaneously administered formulation of furosemide compared with an orally administered formulation, in patients with heart failure having chronic fluid overload (NCT02350725; EudraCT2014-002546-49; SCP01-001). This randomised, open-label study enrolled 10 patients in the Netherlands .