Benzinga | Jul 1, 2021 08:04AM EDT

scPharma Reports Receipt Of Written Minutes From Type-C Meeting With FDA Related To Development Of FUROSCIX

FDA and Company in alignment on the path forward

No additional clinical data or device modifications required at this time

FUROSCIX NDA resubmission targeted for Q4 2021

BURLINGTON, Mass., July 01, 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 on June 30, 2021 the Company received the minutes from its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the requirements for resubmission of the FUROSCIX New Drug Application (NDA).

Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, the Company is moving forward with its original plan to conduct the required bench testing for the West Pharmaceutical Services' (West) SmartDose(r) Gen II on-body drug delivery system that is used to deliver FUROSCIX to heart failure patients. Importantly, the FDA has not requested modifications to the device.

"We are pleased with the outcome of our Type C meeting, and subsequent receipt of the meeting minutes, as this represents an important step forward as we continue to advance FUROSCIX toward potential commercialization," stated John Tucker, chief executive officer of scPharmaceuticals. "In June, West resumed making the commercial devices that will be used for the required bench testing, and subject to the completion of the Device Master File (DMF) by West, we are targeting the resubmission of our NDA in the fourth quarter of this year and anticipate a six-month review by the FDA."

"At the same time, we recently completed enrollment in our FREEDOM-HF study and anticipate topline data in July. The results, if positive, can potentially demonstrate significant cost savings from treating congestion in patients with heart failure with FUROSCIX outside of the hospital setting. We are looking forward to better understanding the potential pharmacoeconomic impact of FUROSCIX within this patient population, and the promise of reducing the burden of heart failure."

scPharmaceuticals ended the first quarter of 2021 with cash, cash equivalents, restricted cash and investments of $96.5 million. The Company believes its cash, cash equivalents, restricted cash and investments are sufficient to fund operations into 2023, unchanged from prior guidance.