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  • sc Pharmaceuticals Inc. announces receipt of writt...

sc Pharmaceuticals Inc. announces receipt of written minutes from type C meeting with the FDA regarding development of Furoscix for the treatment of heart failure

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Published:2nd Jul 2021
scPharmaceuticals Inc. announced that on June 30, 2021 the Company received the minutes from its Type C meeting with the 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 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.”

Furoscix is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via the patented Infusor, a wearable, pre-programed drug delivery system that is applied to the abdomen for subcutaneous drug administration. Furoscix is under review by the FDA for treatment of edema, or fluid overload, in patients with heart failure. The pivotal studies included a pharmacokinetic study that demonstrated 99.6% bioavailability and comparable urine output with subcutaneous infusion of Furoscix compared to an IV bolus of furosemide and a clinical validation and product design study that demonstrated usability and performance of the Infusor. Furoscix has the potential to provide an outpatient alternative to IV furosemide for the treatment of worsening heart failure due to edema that would typically require hospitalization..

Condition: Heart Failure
Type: drug

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