scPharmaceuticals Announces Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion

Rhea-AI Summary

scPharmaceuticals Inc. (Nasdaq: SCPH) announces positive feedback from the FDA for potential expansion of FUROSCIX® indication to include NYHA Class IV heart failure patients. Additionally, the company has received U.S. patents for alternate furosemide formulations, enabling the development of additional subcutaneous administration options and potential clinical utility in new indications.

Positive

• Positive feedback from the FDA for potential expansion of FUROSCIX® indication is a significant achievement, indicating the company's commitment to advancing patient care and addressing unmet medical needs.
• Issuance of U.S. patents for alternate furosemide formulations provides scPharmaceuticals with intellectual property protection, enabling the development of additional product candidates and potential life cycle management strategies for FUROSCIX®.
• Initiation of IND enabling studies for potential product candidates demonstrates the company's proactive approach to product development and regulatory compliance.

Negative

• None.

Company also announces issuance of key patents covering development of alternate formulations of furosemide

BURLINGTON, Mass., Aug. 01, 2023 (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 the Company has received positive Type C meeting feedback from the US Food and Drug Administration (FDA) regarding the potential expansion of the FUROSCIX® indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients. FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

“We are very pleased with the outcome of our recent Type C meeting with the FDA, and believe this paves the way for potential expansion of the FUROSCIX indication to allow for use in NYHA Class IV patients,” stated John Tucker, Chief Executive Officer of scPharmaceuticals. “We estimate that as many as 10% of all heart failure patients are Class IV, and a meaningful percentage of these – as many as 40% - may benefit from FUROSCIX. To that end, we plan to file for Class IV indication expansion by the end of this year.”

The Company also announced today the issuance of U.S. patents covering concentrated formulations of furosemide. This enables the possibility of developing additional furosemide formulations for subcutaneous administration that will provide clinicians with additional dosing flexibility.

The Company has completed initial solubility and stability studies on multiple formulations described in the patent properties, has identified potential product candidates, and commenced IND enabling studies. scPharmaceuticals has additional U.S. patent applications pending that cover various methods of use of such or similar formulations of furosemide for treatment of congestion in patients with heart failure and edema in patients with kidney disease. The Company is also pursuing similar patent protection outside of the United States.

“This additional intellectual property protection is key to our long-term FUROSCIX life cycle management strategy, as it allows for the development of alternate formulations of furosemide that could offer greater dosing flexibility to physicians treating heart failure patients and also creates the potential for development of furosemide formulations that may have clinical utility in new indications, including potentially chronic kidney disease,” concluded Mr. Tucker.

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 potential expansion of the FUROSCIX indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients, the possibility of developing additional furosemide formulations, and our pursuit of patent protection outside of the United States. 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 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 receipt of regulatory approval for any of our product candidates or, if approved, the successful commercialization of such products, risks related to manufacturing and quality assurances processes, risks related to our ability to protect our intellectual property and proprietary technology, and the risk that global economic factors and uncertainties, including as a result of the COVID-19 pandemic, 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, 2022 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 Taudvin
scPharmaceuticals Inc., 781-301-6706
ktaudvin@scpharma.com

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

FAQ

What is the indication of FUROSCIX®?

FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure.

What is the significance of the FDA's feedback?

The FDA's feedback indicates a potential expansion of FUROSCIX® indication to include NYHA Class IV heart failure patients, representing a significant opportunity for scPharmaceuticals.

What is the purpose of the U.S. patents on furosemide formulations?

The U.S. patents enable the development of alternate furosemide formulations, providing greater dosing flexibility to physicians treating heart failure patients and creating potential clinical utility in new indications.

What are the safety considerations for FUROSCIX®?

FUROSCIX® is contraindicated in patients with anuria, hypersensitivity to furosemide or medical adhesives, and in patients with hepatic cirrhosis or ascites. It may cause fluid, electrolyte, and metabolic abnormalities, among other adverse reactions.