In short, chronic kidney disease involves progressive kidney damage and is primarily characterized by the inability to properly or completely filter blood in the body. As a result, many complications can arise if the disease progresses or is left untreated. Common complications of chronic kidney disease include the following: 

Nephrotic syndrome is unique in its relation to chronic kidney disease because it can either cause the disease or manifest as a result of it. On its own, nephrotic syndrome is a kidney disorder caused by damage to the glomeruli, or the filtering units of the kidneys. This condition is characterized by excessive protein loss in the urine (proteinuria), low blood protein levels (hypoalbuminemia), edema, and high cholesterol levels (hyperlipidemia). Albumin helps anchor fluid in the bloodstream, so with low albumin levels many of these patients experience severe edema.  

The major mechanisms of edema include sodium retention, increased capillary pressure, and hypoalbuminemia, which lead to fluid overload and leakage into interstitial spaces. Edema can often be seen in patients with chronic kidney disease, as the kidneys are unable to effectively eliminate sodium and water from the body. This accumulation of excess body fluid is commonly seen in the lower extremities of patients with chronic kidney disease, but it can also occur in the hands, face, and in extreme cases, the lungs.  

The management of edema in chronic kidney disease is one of the best ways to prevent serious complications, improve patient wellbeing, and slow disease progression. The next few sections will discuss some of the different complications of unmanaged edema and why it is important to treat as soon as possible. 

Furoscix is a subcutaneous injection formulation of the loop diuretic furosemide. This unique formulation comes as a pre-filled, on-body drug delivery system that allows patients to receive continuous furosemide without hospital admission. Furosemide is a commonly used diuretic for treating edema and hypertension, with other dosage forms including tablets, oral liquid, and intravenous solutions.

Furosemide works by inhibiting the Na+/K+/2Cl- co-transporter in the thick ascending limb of the loop of Henle in the kidneys.  

This ion transporter plays a crucial role in the reabsorption of sodium, potassium, and chloride ions from the urine back into the bloodstream. By blocking this transporter, furosemide prevents the reabsorption of these ions, leading to an increase in the excretion of sodium, chloride, water, and other electrolytes like potassium and calcium. Increased urine production reduces fluid buildup and mitigates the risks associated with unmanaged edema. 

Furoscix received its initial FDA approval in October of 2022, with the support of an open-label, crossover study of subcutaneous versus intravenous furosemide. In this clinical study, Furoscix showed equivalence in diuresis and bioavailability compared to IV furosemide, supporting Furoscix as an alternative treatment option for patients that require diuresis but cannot easily access inpatient IV treatment.  

This first wave of approval, however, was only for the indication of chronic heart failure congestion. After submitting a supplemental new drug application (sNDA), the FDA has now further approved Furoscix for treating edema in chronic kidney disease and nephrotic syndrome. 

“Expanding the [furosemide injection] 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,” said Suneel Udani, consulting physician at Nephrology Associates of Northern Illinois and Indiana (NANI). “Utilizing [furosemide injection] can potentially help us keep our patients with heart failure and/or CKD at home while we restore and maintain euvolemia.” 

John Tucker, Chief Executive Officer of scPharmaceuticals, also stated that "In anticipation of this approval, [scPharmaceuticals has] taken strategic steps to ensure a successful launch, including key opinion leader engagement, comprehensive market research, and commercial readiness initiatives. [scPharmaceuticals is] excited to introduce FUROSCIX to nephrologists and [is] focused on providing treatment options to both heart failure and CKD patients experiencing acute fluid overload." 

This new indication approval underscores the pharmaceutical industry’s dedication to filling in the gaps of patient care. Ceuticon champions innovation and is devoted to providing actionable insights that can help professionals lead change in the healthcare industry. By staying up to date on current events like Furoscix’ label expansion, we empower healthcare professionals to utilize new developments for improved patient outcomes.