FDA approves first injectable furosemide for self-administration by CHF patients

It is well known that congestion due to worsening heart failure is one of the most common causes of hospital admissions in patients over 65.Therefore there is an area of considerable unmet need for both patients and the health care system for easy to administer home treatment.

The US Food and drug administration has approved first injectable furosemide (Furoscix) formulation for subcutaneous self-administration by patients with congestive heart failure.

FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. FUROSCIX is the first and only FDA-approved subcutaneous loop diuretic that delivers IV equivalent diuresis at home via the FUROSCIX Infusor.

"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. "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 U.S."

IV equivalence was established in a clinical study in which FUROSCIX demonstrated 99.6% bioavailability (90% CI: 94.8%-104.8%) and 8-hour urine output of 2.7 L which was similar to subjects receiving intravenous furosemide. FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX.

"As we move towards commercialization, we have compiled a body of evidence demonstrating the value proposition of FUROSCIX across healthcare stakeholders," said John Mohr, Pharm.D., Senior Vice President, Clinical Development and Medical Affairs 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."

FUROSCIX enables subcutaneous administration at home by the patient or a caregiver with the use of the FUROSCIX On-Body Infusor. The On-Body Infusor for FUROSCIX was developed utilizing West Pharmaceutical Services' proprietary SmartDose®1 On-Body Drug Delivery technology. Once the pre-filled cartridge is inserted into the pre-programmed single-use On-Body Infusor for FUROSCIX and attached to the abdomen, the device is activated with the press of a button to deliver an 80-mg dose over five 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 T. Abraham, M.D., Professor of Internal Medicine (Cardiology), Physiology and Cell Biology and College of Medicine Distinguished Professor at The Ohio State University and scPharmaceuticals Board member. "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® (furosemide injection) 80 mg/10 mL for subcutaneous use

INDICATIONS AND LIMITATIONS OF USE

FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure.

FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX.

IMPORTANT SAFETY INFORMATION

FUROSCIX 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.

Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.

Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.

In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital.

Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued.

Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.

In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment. 

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