Benzinga | Sep 10, 2021 08:12AM EDT

scPharmaceuticals Inc. Highlights Presentation Of Late-Breaking FREEDOM-HF Study Data At The Heart Failure Society Of America Annual Scientific Meeting 2021

Data show statistically significant and meaningful reduction in both heart failure-related and overall healthcare costs for patients treated with FUROSCIX(r) versus a historical comparator group



Company on track to resubmit FUROSCIX NDA in the fourth quarter 2021

BURLINGTON, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) -- 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, today 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 StudyPresenter: Daniel Bensimhon, MDSession: Session PV.01 - Poster Viewing Session IDate: Friday, September 10, 2021Time: 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.