Exhibit 99.1
scPharmaceuticals Inc. Provides Regulatory Update on FUROSCIX®
Type A Post-Action Meeting Minutes Received
BURLINGTON, Mass., October 18, 2018 (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 October 16, 2018, it received minutes from the Type A Post-Action Meeting held on September 24, 2018 between the Company and the U.S. Food and Drug Administration (FDA) to discuss the Company’s New Drug Application (NDA) for FUROSCIX®, scPharmaceuticals’ lead program for the treatment of edema in patients with heart failure. The meeting was scheduled to allow scPharmaceuticals to present new information that the Company believes important in addressing certain issues raised by the FDA in the Complete Response Letter (CRL) received on June 13, 2018, regarding FUROSCIX.
As an outcome of the meeting, the FDA has asked the Company to conduct additional human factors studies and a dose delivery validation study with the recently modified FUROSCIX Infusor. The Company intends to submit requests for Type C meetings with the FDA to determine study protocols. The FDA has not requested any additional clinical trials.
The FDA confirmed the appropriate populations for FUROSCIX are patients with worsening NYHA Class II and III heart failure who display reduced responsiveness to oral diuretics and do not require hospitalization. The FDA has recommended that the label for FUROSCIX, if approved, should state that the FUROSCIX Infusor should not be used as a substitute for IV diuretics for patients who require hospitalization or have been recently discharged.
“We have had productive dialogue with the FDA since receiving the CRL in June and have further clarity following receipt of the minutes from our Type A Post-Action Meeting,” said John Tucker, president and chief executive officer of scPharmaceuticals. “We look forward to working with the FDA to establish the human factors and dose delivery validation protocols and NDA resubmission plan. We remain in a strong financial position with expectedyear-end cash of$80-85 Million, sufficient to complete the human factors and dose delivery validation studies required tore-file FUROSCIX by the end of 2019 and continue with future product and device development.”
About FUROSCIX
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 being developed for treatment of edema, 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 edema.
