Exhibit 99.1
scPharmaceuticals Inc. Announces Results of Type A End-of-Review Meeting with FDA Regarding FUROSCIX® NDA
No additional clinical efficacy, PK or safety data required
December 31, 2020 cash, cash equivalents, restricted cash and investments estimated to be $105 million, sufficient to fund operations through potential FUROSCIX® approval and launch and into 2023
BURLINGTON, Mass. – February 23, 2021 – 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 February 19, 2021, the Company received the official Type A meeting minutes from the U.S. Food and Drug Administration (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 3 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,” Mr. Tucker concluded.
