BURLINGTON, Mass.--(BUSINESS WIRE)--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 a progress update on FUROSCIX® including progress on both the drug and device validation, and the successful completion of the human factors program. FUROSCIX is the Company’s lead program for the treatment of congestion in patients with heart failure and the Company remains on track to resubmit the FUROSCIX New Drug Application (NDA) under the current 505(b)(2) approval pathway with the U.S. Food and Drug Administration (FDA) by mid-year 2020.
The Company has successfully completed their human factors validation study of the FUROSCIX On-body Infusor. The validation study included 60 participants including congestive heart failure patients, healthcare providers, and caregivers, who collectively represent the intended users of FUROSCIX. The study was designed to measure eight observational use metrics and included 900 tasks to assess whether the FUROSCIX On-body Infusor can be safely and effectively used. Results from the study demonstrated a user success rate of 99 percent and support the FUROSCIX On-body Infusor’s use within the intended population.
The Company has also progressed the device validation and drug stability testing, which are key components of the FUROSCIX NDA resubmission. The initial phase of the drug stability study was successfully completed with analytical testing of the drug product batches finalized for the initial timepoints. The Company also accomplished a key aspect of the device validation in which 100 percent of patients met all pre-defined end points in a five-hour simulated wear study. Final testing for both the device and drug stability remains on schedule and will be completed prior to the refiling of the FUROSCIX NDA by mid-year 2020.
“We are pleased to have successfully completed the second of two human factors studies and with the excellent progress on the final elements of our regulatory resubmission,” said John Tucker, president and chief executive officer of scPharmaceuticals. “I am pleased with the pace and focus with which we have advanced this effort. The completion of our human factors program and momentum on the drug stability and device validation work are important milestones for scPharmaceuticals as we move forward with our plan to resubmit the FUSROSCIX NDA with the FDA by mid-year 2020.”
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is being developed for treatment of congestion, or fluid overload, in patients with heart failure. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the planned resubmission of the FUROSCIX NDA, including potential timing of, and the Company’s expected progress towards, the resubmission and the advancement of the Company’s device verification and validation studies. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the ability of the FUROSCIX On-body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, and the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the Company’s most recent Annual Report on Form 10-K on file with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.