scPharmaceuticals, Inc. recently announced positive results from its pharmacokinetic and pharmacodynamics phase 3 pivotal registration trial. The trial in patients with heart failure compared subcutaneous administration of a novel furosemide formulation with intravenous administration of furosemide USP (the commercial reference product). Furosemide is a diuretic; it induces urine output to reduce fluid overload (edema), a hallmark of heart failure. The trial results indicated that the subcutaneous administration of the novel furosemide formulation was as effective as the traditional intravenous administration in getting furosemide into the blood stream, and in achieving diuresis. The subcutaneous administration used a proprietary biphasic delivery profile. The reference treatment was commercial furosemide injection, USP administered intravenously in accordance with its prescribing information.

The cross-over study was designed to provide an accurate estimate of bioavailability after subcutaneous administration. Bioavailability refers to the proportion of the administered dose that can be found in the blood stream. Bioavailability following intravenous administration is considered 100%. FDA reviewed the protocol prior to the start of the study.

This study is part of scPharmaceuticals’ development program for the sc2Wear Furosemide Patch Pump, a proprietary patch pump for subcutaneous administration of the novel furosemide formulation. Subcutaneous administration in this trial used a proprietary biphasic delivery profile. A total of 10mL of the novel furosemide formulation (8mg/mL) was administered over five hours with 30mg in the first hour and 12.5mg/hour for the remaining four hours. The drug was delivered via a very small needle (27G) that penetrates the skin of the abdominal wall. No drug-induced skin-irritation or discomfort was observed. The study details and complete results are expected to be published in a medical journal in 2016.

For results and the remainder of the press release, please go here.