scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease

Rhea-AI Summary

scPharmaceuticals Inc. (Nasdaq: SCPH) announced that the FDA has accepted their Supplemental New Drug Application (sNDA) to expand FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has set a PDUFA target action date of March 6, 2025.

Key points:

• No additional clinical studies needed for indication expansion
• CKD affects more than 1 in 7 U.S. adults
• Estimated $3 billion addressable market
• Company preparing to deploy additional commercial resources if sNDA is approved

FUROSCIX is currently indicated for treating congestion due to fluid overload in adult patients with NYHA Class II and III chronic heart failure.

Positive

• FDA acceptance of sNDA for FUROSCIX indication expansion to include CKD patients
• No additional clinical studies required for indication expansion
• Potential to address an estimated $3 billion market
• Opportunity to improve lives of CKD patients, affecting more than 1 in 7 U.S. adults

Negative

• PDUFA target action date set for March 6, 2025, indicating a lengthy review process
• Approval of sNDA not guaranteed, posing potential risk to expansion plans
• Additional commercial resources may be required if sNDA is approved, potentially increasing expenses

Financial Analyst

The FDA's acceptance of scPharmaceuticals' sNDA for FUROSCIX is a significant milestone with potential financial implications. The expansion to include CKD patients could substantially increase FUROSCIX's market reach, addressing an estimated $3 billion market. This represents a considerable growth opportunity for scPharmaceuticals, potentially boosting future revenues.

However, investors should note that the PDUFA date is set for March 6, 2025, indicating a lengthy review process. This extended timeline may impact short-term stock performance and requires patience from investors. The lack of need for additional clinical studies is a positive factor, potentially reducing costs and accelerating the approval process.

While the news is promising, it's important to consider that FDA approval is not guaranteed. The company's ability to demonstrate an adequate PK and PD bridge to the listed drug will be critical. Investors should monitor the review process closely and be prepared for potential volatility around the decision date.

Medical Research Analyst

The potential expansion of FUROSCIX to include CKD patients is scientifically significant. CKD affects more than 14% of U.S. adults, representing a substantial patient population. The ability to treat fluid overload in these patients with a subcutaneous injection could be a game-changer in managing their condition.

From a research perspective, the FDA's acceptance without requiring additional clinical studies is noteworthy. This suggests confidence in the existing data and the pharmacokinetic/pharmacodynamic (PK/PD) bridging strategy. However, the success of this approach will depend on the robustness of the PK/PD data presented in the sNDA.

It's important to note that while FUROSCIX could provide a new treatment option for CKD patients, its safety profile in this population will be scrutinized. The existing contraindications and warnings, particularly those related to electrolyte imbalances and renal function, will be especially relevant for CKD patients. The FDA's review will likely focus on these aspects to ensure the benefit-risk profile remains favorable in this more vulnerable population.

Market Research Analyst

The potential expansion of FUROSCIX into the CKD market represents a significant opportunity for scPharmaceuticals. With CKD affecting over 1 in 7 U.S. adults, the addressable market is substantial. The company's estimate of a $3 billion market opportunity seems plausible, given the high prevalence of fluid overload episodes in CKD patients.

However, market penetration will depend on several factors. The subcutaneous delivery method of FUROSCIX could be a key differentiator, potentially offering improved convenience over traditional IV furosemide. This could drive adoption among both patients and healthcare providers, particularly in outpatient settings.

Competition in this space should be considered. While FUROSCIX offers a novel delivery method, it will still compete with established treatments. The company's commercial strategy, including pricing and reimbursement plans, will be important in capturing market share. The mention of deploying additional commercial resources suggests scPharmaceuticals is preparing for a significant market push if approved.

Investors should also consider the broader trends in kidney care, including the shift towards home-based and value-based care models. FUROSCIX's potential to reduce hospitalizations could align well with these trends, potentially driving adoption and reimbursement support.

FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025

BURLINGTON, Mass., July 25, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), 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 the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.

In Type D meeting feedback provided by the FDA last year, the agency confirmed that no additional clinical studies would be needed to expand the indication, provided that the Company is able to demonstrate an adequate pharmacokinetic (PK) and pharmacodynamic (PD) bridge to the listed drug, furosemide injection, 10 mg/mL.

“The potential expansion of the FUROSCIX indication to include CKD could support a key long-term growth initiative for our Company, and an opportunity to improve the lives of CKD patients as CKD affects more than 1 in 7 U.S. adults and is characterized by frequent episodes of fluid overload.¹” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We look forward to the review of our application by the FDA and are preparing to deploy additional commercial resources, if our sNDA is approved, to efficiently address what we estimate to be a $3 billion addressable market.”

FUROSCIX^® (furosemide injection) 80 mg/10mL for subcutaneous use

FUROSCIX^® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX.

IMPORTANT SAFETY INFORMATION

FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide or medical adhesives and in patients with hepatic cirrhosis or ascites.

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.

In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued.

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.

The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf.

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. 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 accepted for filing sNDA by the FDA, the potential for FUROSCIX to treat edema due to fluid overload in patients with chronic kidney disease and the potential indication expansion of FUROSCIX, including any necessary regulatory approvals and timing thereof, the applicable PDUFA date, and the potential market opportunity for FUROSCIX to treat such patients. 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, we are heavily dependent on the success of our product candidates and our approved product, FUROSCIX, the risk of any unforeseen delays or setbacks in the commercialization of FUROSCIX, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the risks associated with the enrollment and timely completion of clinical trials; the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; if we fail to produce FUROSCIX in the volumes that we require on a timely basis, we may face delays in our commercialization efforts; if we are unable to expand our sales and marketing capabilities or continue to enter into agreements with third parties to market and sell FUROSCIX, we may be unable to generate any revenue; we have a limited operating history and no history of commercializing pharmaceutical products, which may make it difficult to evaluate the prospects for our future success; 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; and our success depends on our ability to manufacture, or the ability of third parties to deliver, sufficient quantities of supplies, components and drug product for commercialization of FUROSCIX or any of our product candidates, if approved, including our ability to monitor quality control issues related to the production of FUROSCIX and on-body infusors in the volumes that will be required on a timely basis. 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
kmiranda@scpharma.com

Investors:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com

¹ Kidney Disease Statistics for the United States, National Institute of Diabetes and Digestive and Kidney Diseases, May 2023, https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

FAQ

What is the new indication scPharmaceuticals is seeking for FUROSCIX?

scPharmaceuticals is seeking to expand FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD).

When is the PDUFA target action date for scPharmaceuticals' sNDA for FUROSCIX?

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025 for scPharmaceuticals' sNDA for FUROSCIX.

What is the current indication for FUROSCIX (SCPH)?

FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

What is the estimated market size for the expanded indication of FUROSCIX (SCPH)?

scPharmaceuticals estimates the addressable market for the expanded indication of FUROSCIX to be approximately $3 billion.