scPharmaceuticals Inc. Announces Recent Progress on FUROSCIX® and Highlights Corporate Objectives
December 12 2019 - 08:00AM
Business Wire
Successful completion of human factors program
ahead of FUROSCIX NDA resubmission
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.”
About FUROSCIX
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.
About scPharmaceuticals
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.
Forward-Looking Statement
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191212005136/en/
Katherine Taudvin, scPharmaceuticals Inc. 781-301-6706
ktaudvin@scpharma.com
Christopher F. Brinzey, Westwicke, an ICR Company 339-970-2843
chris.brinzey@westwicke.com
scPharmaceuticals (NASDAQ:SCPH)
Historical Stock Chart
From Feb 2024 to Mar 2024
scPharmaceuticals (NASDAQ:SCPH)
Historical Stock Chart
From Mar 2023 to Mar 2024