scPharmaceuticals Inc. announces results of type A end-of-review meeting with FDA regarding Furoscix, a treatment for edema in patients with heart failure.

scPharmaceuticals Inc. announced that on February 19, 2021, the Company received the official Type A meeting minutes from the FDA regarding the requirements for resubmission of the Furoscix 505(b)(2) New Drug Application (NDA) following the Complete Response Letter (CRL) received on December 3, 2020. The outstanding questions are primarily focused on Pre-Approval Inspections and bench testing. The Company will run additional modified bench tests on aged commercial units of the West Pharmaceutical Services, Inc.’s SmartDose Gen II on-body infusor. The FDA is not requiring modifications to the device nor is it requiring the company to perform additional clinical studies to demonstrate the safety and efficacy of Furoscix.The Company still anticipates the need for Pre-Approval Inspections of the West Pharmaceutical Services’ facility in Scottsdale, Arizona, the Sharp Packaging Services’ facility in Allentown, Pennsylvania and the third-party manufacturer of the off-the-shelf alcohol swabs. John Tucker, Chief Executive Officer of scPharmaceuticals, stated: “We are pleased to have had a very productive meeting with the FDA to discuss key elements of the CRL. We have developed a plan that we believe will address the FDA’s outstanding questions and will conduct the modified bench testing which we anticipate will allow us to resubmit our FUROSCIX NDA in the third quarter of this year. “In parallel, our Phase III FREEDOM clinical trial is progressing well. This trial is evaluating overall and heart failure-related costs for subjects treated with Furoscix for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for less than or equal to 72 hours following hospitalization. If positive, we believe these data will demonstrate compelling clinical and pharmacoeconomic benefits of FUroscix, as a potential intervention for worsening heart failure patients pre- and post-discharge,” 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..