The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for Furoscix® (scPharmaceuticals) as an outpatient alternative for the treatment of worsening heart failure due to congestion.
Furoscix is an investigational, proprietary, pH-neutral formulation of furosemide designed for subcutaneous administration via a wearable, preprogrammed on-body drug delivery system for outpatient self-administration.
The NDA for Furoscix was initially accepted for filing by the FDA in November 2017 under the 505(b)(2) regulatory pathway. In June 2018, the Agency issued a Complete Response Letter (CRL) to the Company indicating the need for additional human factors studies and device modifications.
Following the CRL, the Company completed an additional human factors validation study of the Furoscix on-body infusor, which included 60 patients, healthcare providers and caregivers, to assess whether it could be used safely and effectively. Results of the study showed a user success rate of 99%. Additionally, the Company completed drug stability testing as well as additional device testing, which showed that the on-body delivery system maintained adherence to the skin of the abdomen.
“We believe we have successfully addressed the questions and concerns previously raised by the agency in its 2018 Complete Response Letter and we look forward to working with the agency during its review process,” said John Tucker, President and CEO of scPharmaceuticals. “If approved, we believe Furoscix has the potential to benefit patients and payers alike and provide physicians a new tool in the battle to treat worsening heart failure.”
A Prescription Drug User Fee Act (PDUFA) target date of December 30, 2020 has been set for this application.
For more information visit scpharmaceuticals.com.
1. scPharmaceuticals announces FDA acceptance of FUROSCIX® new drug application resubmission. https://www.businesswire.com/news/home/20200727005117/en/scPharmaceuticals-Announces-FDA-Acceptance-FUROSCIX%C2%AE-New-Drug. Published July 27, 2020. Accessed July 28, 2020.
2. scPharmaceuticals receives complete response letter from the FDA for FUROSCIX®. https://www.globenewswire.com/news-release/2018/06/13/1520957/0/en/scPharmaceuticals-Receives-Complete-Response-Letter-from-the-FDA-for-FUROSCIX.html. Published June 13, 2018. Accessed July 28, 2020.