Corstasis Therapeutics Inc. announced on September 15,2025 that the U.S. Food and Drug Administration (FDA) has approved ENBUMYST™ (budesonide nasal spray). The medication is indicated for treating edema associated with congestive heart failure (CHF) and liver/kidney disorders, including adult nephrotic syndrome.

Edema and fluid overload remain the primary causes of hospitalization and readmission in patients with congestive heart failure, cirrhosis, and chronic kidney disease. According to U.S. treatment data, 6.7 million Americans are estimated to have heart failure, with fluid overload leading to over one million annual hospitalizations and costing billions in healthcare expenditures. While oral loop diuretics may be limited by gastrointestinal absorption issues and delayed onset, intravenous (IV) therapy often requires hospitalization or infusion settings – a practice associated with higher resource utilization rates and increased medical costs.

Bumetanide, a potent loop diuretic, primarily acts on the ascending limb of the renal medulla to inhibit sodium and chloride reabsorption. This mechanism enhances excretion of sodium, chloride, and potassium, thereby inducing significant diuresis. It is commonly used to treat edema-related conditions such as congestive heart failure, cirrhosis, and kidney diseases. The Bumetanide Nasal Spray enables patients to self-administer non-oral loop diuretic therapy through nasal mucosa in outpatient settings.

The RSQ-777-02 trial was conducted from December 2023 to April 2024 at the Orange County Research Center and presented as the latest scientific achievement at the 2024 American Heart Association (AHA) Scientific Meeting. The study involved 68 adults aged 18 to 55 with no prior heart failure or risk of developing it. Participants received bumetanide in all three administration routes (nasal spray, oral medication, and intravenous injection) in randomized sequences. Demographics showed 66.2% male participants, with 60.3% Caucasian, 27.9% Black, and 10.3% Asian. Additionally, 32.4% were classified as Hispanic or Latino.

The study found that the nasal spray demonstrated comparable safety and tolerability to oral and intravenous administration, with no significant nasal irritation. Researchers noted a 27% difference in absorption rates between bumetanide's nasal spray and intravenous forms compared to the oral pill formulation (over 40%), indicating these routes offer more stable delivery. Additionally, the nasal spray resulted in similar urine output levels compared to oral and intravenous administration of bumetanide.

Analysis demonstrates that bumetanide nasal spray exhibits effective absorption and good tolerability, with consistent side effects compared to other administration methods. It shows fewer treatment-related adverse events (TEAEs) than oral formulations. The nasal spray maintains urinary output and blood concentration levels comparable to oral and intravenous bumetanide, while demonstrating 33% faster absorption rates.

According to these data, intravenous bumetanide demonstrates faster absorption than oral and nasal formulations, while nasal administration shows quicker onset in urinary sodium excretion. Additionally, for each participant who ultimately received all three bumetanide formulations, nasal and intravenous routes exhibited more stable absorption compared to oral administration. Overall, the absorption variability for nasal and intravenous bumetanide was 27%, whereas oral formulation showed>40% variability. This indicates that nasal and intravenous routes are more stable, and nasal spray formulations have an advantage over oral ones in self-administration at home.

The most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, low blood pressure, nausea and encephalopathy (in patients with pre-existing liver disease).

ENBUMYST introduces a novel self-administered outpatient diuretic therapy that may bridge the gap between oral and intravenous diuretics. Corstasis is scheduled to launch ENBUMYST in the U.S. during the fourth quarter of 2025 and is developing a robust market access strategy featuring real-world outcome data and payer partnerships to accelerate adoption and coverage. Given the high prevalence of heart failure and chronic kidney disease, along with unmet demand for therapies that reduce costly hospitalizations and readmissions, this innovation is projected to unlock a multi-billion dollar market opportunity annually.

Ref:https://www.businesswire.com/news/home/20250915243998/en/Corstasis-Therapeutics-Announces-FDA-Approval-of-ENBUMYST-bumetanide-nasal-spray-for-the-Treatment-of-Edema-Associated-with-Congestive-Heart-Failure-Liver-Disease-and-Kidney-Disease

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