scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX® Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease
FDA approves scPharmaceuticals' supplemental New Drug Application to expand the FUROSCIX indication to include the treatment of edema in adult patients with chronic kidney disease, including nephrotic syndrome
FUROSCIX is expected to be available for chronic kidney disease patients in April 2025
BURLINGTON, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH) (the "Company"), a pharmaceutical company committed to revolutionizing cardiorenal healthcare through patient-centric innovations, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).
"We are thrilled to announce that the FDA has approved the sNDA for FUROSCIX, expanding the indication to include the treatment of edema in patients with chronic kidney disease. This milestone marks a significant step forward for the FUROSCIX franchise and underscores our commitment to addressing unmet needs of cardiorenal patients," said John Tucker, Chief Executive Officer of scPharmaceuticals. "In anticipation of this approval, we have taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. We are excited to introduce FUROSCIX to nephrologists and are focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload."
"Expanding the FUROSCIX indication to include patients with chronic kidney disease will provide a much-needed additional tool for clinicians to utilize in our management of fluid overload," stated Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana (NANI). "Utilizing FUROSCIX can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia."
INDICATION
FUROSCIX® (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation, or medical adhesives.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
Please see the full Prescribing Information (www.furoscix.com/prescribing-information.pdf) and Instructions for Use (www.furoscix.com/instructions-for-use.pdf).
About scPharmaceuticals
At scPharmaceuticals, we are powered by passion, driven by patient care. Our Mission is focused on advancing cardiorenal care through innovative, integrated treatments that address unmet patient needs.
Our goal is to become the foremost advocate for patient-centric cardiorenal care, driving global health improvements through specialized, multidisciplinary approaches. scPharmaceuticals is expanding its reach, offering integrated therapies and products that address diverse healthcare needs and potentially improve the lives of our patients. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential of our products to treat edema in CKD patients, advance patient care and reduce healthcare costs for patients, and the market recognition of FUROSCIX; and the timing of any of the foregoing. 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, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates; risks related to the receipt of regulatory approval for our product candidates; risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved; risks related to our history of operating losses, we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability; we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts; the terms of our credit facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; and the risk that global economic factors and uncertainties will impact the Company's operations. For a discussion of these and 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 sections entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission's website at www.sec.gov, 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.
Katherine Miranda
scPharmaceuticals Inc., 781-301-6869
[email protected]
Investors:
Nick Colangelo
Gilmartin Group, 339-225-1047
[email protected]
