FDA Approves Furosemide Injection for Congestion in Patients with Chronic Heart Failure

The FDA has approved furosemide injection 80 mg/10 mL (Furoscix; scPharmaceuticals) for the at-home treatment of congestion in patients with chronic heart failure. The drug’s proprietary formulation of furosemide is administered via a delivery system called an On-Body Infusor.

The treatment is indicated for congestion caused by fluid overload in adult patients with New York Heart Association (NYHA) Class II/III chronic heart failure. The FDA action adds to the available options for providers managing worsening heart failure, which affects more than 6 million Americans and costs more than $30 billion annually in care costs, according to scPharmaceuticals.

“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 scPharmaceuticals board member William T. Abraham, MD, professor of Internal Medicine, Physiology and Cell Biology at The Ohio State University, in a press release. “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.”

Furoscix, the first and only self-administered subcutaneous loop diuretic for congestion associated with chronic heart failure, is administered in subcutaneous doses with a wearable, pre-programmed delivery system placed on the patient’s body.

Furoscix treats congestion associated with heart failure by lowering fluid overload in patients with NYHA Class II and III chronic heart failure who do not require hospitalization but have not experienced a full response to oral diuretics.

In the multicenter, randomized, phase 2 AT HOME-HF pilot study, subcutaneous furosemide 80 mg/10 mL was compared with standard care in 51 patients with chronic heart failure with congestion uncontrolled by diuresis. The trial showed a 37% lower risk of heart failure hospitalization among patients in the investigational cohort vs patients in the standard care cohort at 30 days.

Key secondary endpoints showed furosemide leads to greater declines in mean patient body weight from baseline to day 3 (2.8 vs 0.8; P = .035) and improvements in pulmonary-related metrics, including improved mean 5-item dyspnea score from baseline to day 3 (-0.5 vs 0.1; P = .019).

Furosemide injection is not indicated for use in emergency situations or in patients with acute pulmonary edema. The drug 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.

“Congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65, and today’s approval of Furoscix represents an important treatment advancement for the over 7 million heart failure patients in the US that will be able to self-administer IV equivalent diuresis at home,” said John Tucker, president and chief executive officer of scPharmaceuticals, in the release. “We are preparing to optimize commercialization efforts to offer Furoscix to patients in the first quarter of next year with the goal of driving rapid patient adoption to meet the needs of the $5.9 billion addressable market in the US.”

Reference

scPharmaceuticals Announces FDA Approval of FUROSCIX® (furosemide injection), the First and Only Self-administered, Subcutaneous Loop Diuretic for the At-home Treatment of Congestion in Chronic Heart Failure. scPharmaceuticals. News release. October 10, 2022. https://scpharmaceuticalsinc.gcs-web.com/news-releases/news-release-details/scpharmaceuticals-announces-fda-approval-furoscixr-furosemide