scPharmaceuticals Announces Positive Results from Pivotal Trial of its Novel Subcutaneous Furosemide Formulation in Patients with Heart Failure

LEXINGTON, Mass.,  scPharmaceuticals, Inc. today 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.

scPharmaceuticals reports the following results:

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.

Furosemide is the most widely used injectable cardiovascular drug with approximately 30M units administered in the US alone.  With rare exception, furosemide injections are given intravenously by inserting a cannula in a vein of the hand or forearm.  Placing an IV cannula, unlike phlebotomy, is an invasive procedure that may only be performed by certified healthcare professionals, such as nurses, EMT and physicians.  Subcutaneous administration is easier, less painful, and can often be performed by patients, caregivers and non-certified healthcare professionals such as medical assistants. 

"These results confirm that we can achieve "IV-like" diuresis with subcutaneous administration of the novel furosemide formulation," said Pieter Muntendam, MD, President and CEO of scPharmaceuticals. "One in three Medicare dollars is spent on patients with heart failure with close to 60% of this for inpatient care.  This novel option would facilitate more prompt diuresis management to avoid hospital admissions or finish treatments at home to reduce length of stay."

"Addressing unsustainable health care costs requires innovative, cost-saving technologies that better manage and treat common, serious, and expensive medical conditions," said Leonard Schaeffer, a member of the scPharmaceuticals Board of Directors, founding Chairman and CEO of WellPoint (now Anthem), and previous Administrator of the Health Care Financing Administration (HCFA – now CMS). "Payers are targeting high-cost conditions, such as heart failure, where there is opportunity to improve care. scPharmaceuticals' subcutaneous furosemide product is being developed in response to the incentives to treat heart failure patients more promptly and efficiently in lower cost care settings."

"Over the past 50 years, improvements in heart failure management have been incremental, not transformative," said Bertram Pitt, MD, Professor of Medicine Emeritus at the University of Michigan and co-founder of scPharmaceuticals.  "The demonstration that the subcutaneous administration of furosemide can mimic the effects of IV administration enables a new care model for effective prevention and treatment of fluid overload outside high-cost care centers.  When adopted, this could markedly reduce hospital admissions and readmissions for heart failure thereby increasing patient satisfaction and reducing health care costs."

scPharmaceuticals is in an advanced stage of developing its drug-device combination product that is subject to FDA's 505(b)(2) NDA review and approval procedure prior to introduction.  scPharmaceuticals expects to submit the NDA in mid-2016.  International regulatory filings are anticipated for the second half of 2016.

Source: scPharmaceuticals, Inc