|View printer-friendly version|
“As we look forward to our upcoming
Commercial Preparedness Activities
To prepare for the launch of FUROSCIX, if approved, the Company has made key additions to its commercial team, including vice presidents of marketing, sales and market access. In addition, recruitment for the Company’s field sales team is ongoing and remains closely aligned with currently anticipated regulatory timelines.
12 Month Drug Stability Data
The Company has submitted twelve-month drug stability data to the
Heart Failure Society of America (HFSA) Virtual Annual
scPharmaceuticals participated in three virtual poster presentations at the HFSA Virtual Annual Scientific Meeting 2020. Posters included:
FUROSCIX Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure - (FREEDOM-HF)
• The methods for an ongoing, interventional clinical trial evaluating the economic impact of treating patients who present to the emergency department with worsening heart failure due to congestion with FUROSCIX outside the hospital setting are described.
Heart Failure Related Costs and Health Care Resource Utilization Following an
Emergency Department(ED) Visit for Worsening Heart Failure: A Claims Data Analysis
• Patients hospitalized for less than 72 hours after presenting to the ED for worsening heart failure (WHF) have average 30-day all-cause and heart failure related costs of
$19,560and $14,283, respectively.
• Patients presenting to the ED for WHF and not hospitalized have 30-day all-cause and heart failure related outpatient costs of
$6,401and $5,034, respectively.
Successful Validation of a Wearable, On-Body Infusor for
Subcutaneous Administration of FUROSCIXin Heart Failure Patients, Caregivers, and Health Care Practitioners
• Patients with heart failure, caregivers and health care providers followed the Instructions for Use (IFU) to safely and effectively operate the On-Body Infusor for FUROSCIX where-by no patterns of use errors were observed in both trained and untrained participants.
Key Opinion Leader Webinar
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® (furosemide injection) for subcutaneous administration is currently under development for the treatment of congestion due to fluid overload in adult patients with worsening
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
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 expected timing of the FDA’s review of the FUROSCIX NDA, the potential timing of, and the Company’s expected progress towards, the advancement of the Company’s device verification, research and validation studies, the Company’s planned efforts to prepare for commercialization of FUROSCIX and the success of such commercialization, and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved. 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 risk of 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, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, the timing of the FDA’s review of the Company’s FUROSCIX NDA and other operations. 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 its Annual Report on Form 10-K for the year ended
scPharmaceuticals Inc., 781-301-6706
Source: scPharmaceuticals Inc.