FDA Approves Furosemide Injection for At-Home Treatment of Congestion in Chronic Heart Failure

The US Food and Drug Administration (FDA) has approved furosemide injection 80 mg/ 10 mL (FUROSCIX) for the at-home treatment of congestion in patients with chronic heart failure.

Announced on October 10 in a statement from scPharmaceuticals, the approval adds to the armamentarium available for prescribers managing worsening heart failure, a disease that impacts more than 6 million Americans and costs more than $30 billion in care annually.

The first and only self-administered subcutaneous loop diuretic for at-home treatment of congestion in chronic heart failure, the proprietary furosemide solution is administered in subcutaneous doses via a wearable, pre-programmed delivery system, called the On-Body Infusor, placed on the patient’s body.

“This marks a tremendous opportunity to improve the at-home management of worsening congestion in patients with heart failure who display reduced responsiveness to oral diuretics and require administration of intravenous diuretics, which typically requires admission to the hospital,” said William T. Abraham, MD, Professor of Internal Medicine, Physiology and Cell Biology at The Ohio State University and scPharmaceuticals Board member, in the aforementioned statement. “The FDA’s approval of FUROSCIX is significant and will allow patients to be treated outside of the hospital setting, and I look forward to incorporating it into my own practice as quickly as possible.” 

The furosemide solution targets heart failure-related congestion by reducing fluid overload in adult patients with NYHA Class II and III chronic heart failure who do not require hospitalization but also have not had full response to oral diuretics. As such, it will be available for outpatient use.

Data from the phase 2 AT HOME-HF Pilot study—a multicenter, randomized trial assessing subcutaneous furosemide 80 mg/10 mL versus standard care in 51 patients with chronic heart failure with congestion uncontrolled by diuresis—showed a 37% reduced risk of heart failure hospitalization among treated patients compared to standard-care patients at 30 days.

In key secondary endpoints, furosemide was associated with greater reductions in mean patient body weight from baseline to day 3 (2.8 vs 0.8; P = .035), as well as improvements in pulmonary-related metrics including mean 5-item dyspnea score improvement from baseline to day 3 (-0.5 vs 0.1; P = .019).

The data, presented at the Heart Failure Society of America (HFSA) 2022 Annual Meeting in Washington, DC last week, signaled a new opportunity to manage heart failure in pre-hospitalized patients.

“This small study points to a possible new way to treat patients with heart failure exacerbation without hospitalization,” said Marvin Konstam, MD, professor of medicine at Tufts University School Medicine, said in his AT HOME-HF presentation at HFSA 2022. “The AT-HOME HF study, with limited statistical power, generated a directional favorable primary end point which was not statistically significant.”

Konstam added the findings support a “cohesive message with statistical significance across body weight, dyspnea scores, and functional capacity, with an analogous trend in health-related quality of life.”

In their release, scPharmaceuticals noted furosemide injection is not indicated for use in emergency situations or in patients with acute pulmonary edema. Additionally, furosemide injection 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.