麻豆传媒

The FDA approved the first furosemide (Furoscix) formulation for subcutaneous self-administration by patients with congestive heart failure, scPharmaceuticals .

The IV-equivalent formulation is indicated for the treatment of congestion due to fluid overload in people with New York Heart Association class II/III chronic heart failure. It is administered at home with use of a single-use Furoscix On-Body Infusor, which involves a pre-filled cartridge containing the loop diuretic that attaches to the patient's abdomen for delivery of an 80-mg dose over 5 hours.

"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 Abraham, MD, of The Ohio State University in Columbus, in the company press release.

According to scPharmaceuticals, a clinical study had found subcutaneous furosemide to be associated with 99.6% bioavailability and an 8-hour urine output of 2.7 L, on par with that from the IV formulation.

Subcutaneous furosemide is not indicated for use in emergency situations or in patients with acute pulmonary edema. It is contraindicated in people with anuria, those with a history of hypersensitivity to furosemide or medical adhesives, and individuals with hepatic cirrhosis or ascites.

Furosemide can cause fluid, electrolyte, and metabolic abnormalities in elderly patients and other groups. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with this diuretic.

Monitoring for serum electrolytes, carbon dioxide, blood urea nitrogen, creatinine, glucose, and uric acid remains important during furosemide therapy.

"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 seven million heart failure patients in the U.S. that will be able to self-administer IV equivalent diuresis at home," said John Tucker, president and chief executive officer of scPharmaceuticals.

"The totality of clinical and pharmacoeconomic data that we have generated to date supports an opportunity to shift the treatment paradigm of how heart failure patients with congestion are treated and has the potential to become a new standard of care," Tucker added in the press release.

The drug manufacturer plans for commercial launch in early 2023.

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