The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Furoscix® for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization.
Furoscix is an investigational, pH-neutral formulation of furosemide designed for subcutaneous administration via a wearable, pre-programmed on-body drug delivery system for outpatient self-administration.
The NDA submission includes data from the FREEDOM-HF study (ClinicalTrials.gov Identifier: NCT03458325), which evaluated admission avoidance and the overall economic impact associated with management of worsening heart failure using Furoscix outside the hospital in patients initially presenting to the emergency department (ED). The control arm included patients who presented to the ED and were admitted to the hospital for 72 hours or less for the treatment of heart failure with intravenous diuretics.
Results showed a highly statistically significant reduction in 30-day heart failure-related costs in patients who received Furoscix compared with the comparator arm. The mean difference in heart failure-related costs between the 2 groups was $17,753 per study participant (P <.0001), driven primarily by hospitalization costs. Among the 24 patients treated with Furoscix, none required an initial heart failure hospitalization and 95.8% remained out of the hospital for the subsequent 30-day period.
“We believe Furoscix, if approved, will address a significant need along the heart failure care continuum. By providing a new option for the treatment of congestion related to heart failure, all stakeholders – patients, payers and providers – stand to benefit, and there is the potential to generate significant health care system cost savings,” said John Tucker, CEO of scPharmaceuticals. “We look forward to engaging with the FDA and continue to prepare for a successful Q4 2022 commercial launch should Furoscix be approved.”
A Prescription Drug User-Fee Act (PDUFA) target date of October 8, 2022 has been set for the application.
- scPharmaceuticals Inc. announces FDA acceptance of Furoscix® New Drug Application. News release. scPharmaceuticals Inc. May 16, 2022. https://www.globenewswire.com/news-release/2022/05/16/2443686/0/en/scPharmaceuticals-Inc-Announces-FDA-Acceptance-of-FUROSCIX-New-Drug-Application.html
- scPharmaceuticals Inc. announces positive top-line results from FREEDOM-HF study. News release. scPharmaceuticals Inc. July 13, 2021. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-inc-announces-positive-top-line-results