FDA Approves Heart Failure Therapy that Provides an Alternative to Hospital Treatment

The FDA has approved scPharmaceuticals’ Furoscix (furosemide injection) to treat adult patients with congestion due to fluid overload in chronic heart failure. It uses a proprietary formulation of furosemide delivered via an On-Body Infusor and delivers an 80-mg dose that is an equivalent of IV diuresis.

Furoscix enables subcutaneous administration at home by the patient or a caregiver with the use of the On-Body Infusor, which was developed using West Pharmaceutical Services SmartDose technology. Once the pre-filled cartridge is inserted into the pre-programmed infusor and attached to the abdomen, the device is activated to deliver the 80-mg dose over five hours.

Company officials said Furoscix will be launched in the first quarter of 2023, but indicated no information is available on the cost of the therapy. Medicare D will be the predominant payer segment for Furoscix, and a spokesperson said the company is focused on seven priority payer/PBM targets representing >85% of the Medicare lives payer landscape: United Health, Humana, CVS/Aetna, ESI/Cigna, Centene/WellCare, Anthem and Kaiser.

“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,” 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, said 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.”

The approval is based on a study in which Furoscix demonstrated 99.6% bioavailability and eight-hour urine output of 2.7 L, which was similar to patients who receive intravenous furosemide.

Another study sponsored by scPharmaceuticals examined the cost of treatment at home versus the cost of inpatient treatment. The study enrolled 90 patients, 24 in the Furoscix group and 66 in the comparator group, and found that mean 30-day heart-failure-related costs were $17,753 lower in the Furoscix treated group ($2,920) versus the comparator group ($20,673). The study, however, didn’t include the cost of Furoscix.

Furoscix is not indicated for use in emergency situations or in patients with acute pulmonary edema.