BURLINGTON, Mass. - 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, announced that data from its recently-completed FREEDOM-HF clinical trial will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2021. In the FREEDOM-HF study, heart failure (HF) patients with mild to moderate volume overload (despite oral diuretic use) and treated with subcutaneous FUROSCIX were successfully managed in the outpatient setting resulting in significantly reduced HF-related and overall healthcare costs through reduction of HF-related hospitalizations and rehospitalizations.
'We are pleased to present these very compelling results from the FREEDOM-HF study at this year's HFSA meeting,' stated John Tucker, chief executive officer of scPharmaceuticals. 'In this study, there was a highly statistically significant and meaningful cost savings associated with treating HF patients with FUROSCIX. These data provide a strong pharmacoeconomic case for the broad adoption of FUROSCIX as a viable HF treatment pre-admission or post-discharge, if approved by the Food and Drug Administration (FDA).
Following our Type-C meeting with the FDA in June, we are aligned with the agency on the regulatory path forward, are well financed with more than $90 million on hand as of June 30, 2021, and remain on track to re-submit our New Drug Application (NDA) in the fourth quarter of this year.'
FREEDOM-HF was a prospective clinical trial evaluating 30-day heart failure-related and overall costs of treating congestion in patients with chronic HF. Patients were treated with FUROSCIX, the Company's investigational product, post-discharge from the emergency department compared to a historical comparator group that was managed in the hospital setting.
The HFSA Annual Scientific Meeting 2021 is being held virtually and in a hybrid format in Denver, Colorado from September 10-14, 2021. A copy of the poster can be accessed under the News and Events section of the Company's website.
Late-breaking HFSA Poster Presentation Details and Data:
Title: Significantly Reduced Healthcare Costs with Home FUROSCIX Versus in Hospital IV Diuresis: Results from the FREEDOM-HF Study
Presenter: Daniel Bensimhon, MD
Session: Session PV.01 - Poster Viewing Session I
Date: Friday, September 10, 2021
Time: 6:36-6:46pm MT (8:36-8:46pm ET)
90 subjects were enrolled in the study, 24 in the FUROSCIX group and 66 in the comparator group.
Comparators were hospitalized for ?72 hours and were selected from a claims database matched to seven variables associated with HF-related hospitalization and severity. Baseline patient characteristics (key matching variables) were similar between the study groups, as were the incidence of co-morbidities and HF medication use.
FUROSCIX utilization led to a statistically significant reduction in 30-day HF-related and overall healthcare costs.
Mean 30-day HF-related costs were $17,753 lower in the FUROSCIX treated group ($2,920) versus the comparator group ($20,673, p-value