FDA Offers Positive Feedback on Expansion of Heart Failure Drug to Class IV Indication: A Breakthrough in Treating Advanced Heart Failure

scPharmaceuticals Inc. (Nasdaq: SCPH), a revolutionary pharmaceutical company dedicated to improving the delivery of infused therapies, advancing patient care and reducing healthcare costs, has just received great news from the FDA. Following a successful Type C meeting, the Company is one step closer to receiving the expansion of the FUROSCIX® indication – this will now allow its usage in New York Heart Association (NYHA) Class IV heart failure patients! FUROSCIX has already been approved for NYHA Class II and Class III chronic heart failure. This is a tremendous achievement that could go a long way in providing reliable relief and quality care for more patients.

scPharmaceuticals is thrilled with the outcome of their recent Type C meeting with the FDA that paves the way for potential expansion of the FUROSCIX indication to NYHA Class IV patients. With this potential expansion, up to 10% of all heart failure patients, with a meaningful percentage of 40%, may benefit from FUROSCIX. scPharmaceuticals plan to file for the Class IV indication expansion by the end of this year.

The Company is proud to announce the issuance of U.S. patents for concentrated formulations of furosemide, allowing for the potential development of new furosemide formulations to be administered via subcutaneous injection – offering clinicians greater dosing flexibility in their treatment plans.

scPharmaceuticals has recently completed initial solubility and stability studies on multiple formulations described in its patent properties, identifying promising product candidates and initiating IND enabling studies. The Company also has multiple patent applications pending in the US and beyond, protecting the use of furosemide in treating heart failure-related congestion and kidney disease-related edema. With these promising developments, scPharmaceuticals is striving to make significant headway in treating a variety of conditions.

With this new intellectual property protection, we are furthering our FUROSCIX life cycle management strategy to develop alternate formulations of furosemide that provide expansive dosing flexibility for treating heart failure patients. Moreover, these advancements open up exciting opportunities to explore new indications, potentially chronic kidney disease, highlighting the promise and potential of furosemide.

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

FUROSCIX® is the perfect solution for treating congestive heart failure in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. It can help to remove excess fluid buildup in the body, relieving congestion in a safe and effective manner. The On-Body Infusor will deliver an 80mg dose of FUROSCIX, making it a perfect choice for those not requiring immediate relief from acute pulmonary edema. Stop congestion in its tracks with FUROSCIX today!


FUROSCIX is a powerful medication, and it is not for everyone. Those with anuria, a history of hypersensitivity to furosemide or medical adhesives, or those with cirrhosis or ascites of the liver should steer clear of this potent drug. If you have any of the preceding conditions, it is important to consult with your health care professional to ensure safe treatment.

Furosemide may lead to various changes in fluid balance, electrolyte balance and metabolism. To ensure the best outcome, regular monitoring must be done and these may include measuring serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid levels. This is especially important in those on a higher dose, those without enough oral electrolyte intake, and in the elderly.

Diuresis, if excessive, can be detrimental, leading to a dangerous drop in blood volume, causing the circulatory system to collapse and potentially putting seniors at a higher risk of vascular thrombosis or embolism. Dehydration can occur as a result, making it important to be aware of and mindful of diuresis in elderly patients.

Changes to fluid and electrolyte levels can quickly lead to extreme complications such as hepatic encephalopathy and coma in those suffering from hepatic cirrhosis and ascites. As such, swift and proper treatment should always begin in the hospital setting.

Furosemide can cause a host of dangerous conditions, such as dehydration and azotemia, which can be particularly hazardous to those with severe progressive renal disease. If these symptoms become worse while taking this diuretic, it is important to pause treatment and discontinue it altogether.

Furosemide has been reported to cause tinnitus and cause hearing impairment or even deafness, particularly when injected quickly, taken in high doses, combined with aminoglycoside antibiotics or ethacrynic acid, or taken by those with severe renal impairment or hypoproteinemia. Fortunately, in some cases, the hearing impairment or deafness can be reversed, but caution is recommended when considering the use of this medication.

For patients experiencing severe urinary retention caused by bladder emptying disorders, prostatic hyperplasia, or urethral narrowing, furosemide administration can initially worsen symptom severity, so close monitoring is essential during the early stages of treatment. The drug increases the production of urine, resulting in heightened retention complications that can be potentially dangerous.

The administration of FUROSCIX in clinical trials was often accompanied by adverse reactions such as site and skin reactions, including erythema, bruising, edema, and soreness at the injection site. These negative reactions were often quite visible and unexpected.

About scPharmaceuticals

scPharmaceuticals is revolutionizing the healthcare world with innovative solutions that simplify treatments and improve health outcomes. By investing in research and strategic partnerships, the Company is committed to unveiling groundbreaking products that eliminate cost barriers and make subcutaneous, self-administration of IV-strength treatments for select acute conditions accessible to all. Pioneering more effective and efficient healthcare solutions, scPharmaceuticals is a leader the industry based in Burlington, MA.

Forward-Looking Statement

FUROSCIX is poised to make an impact on the treatment of heart failure, and our team is actively working to expand its current indication to include use in New York Heart Association (NYHA) Class IV patients. Additionally, we are actively pursuing patent protection outside the United States and looking into developing additional FUROSCIX formulations. While there are risks associated with this endeavor, including delays or setbacks in commercialization or the potential inability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, we understand the potential of FUROSCIX to improve lives and are determined to see it through, even amid the challenges of the COVID-19 pandemic.

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