FDA approves scPharmaceuticals’ on-body infusor for congestive heart failure

The US Food and Drug Administration (FDA) has approved scPharmaceuticals’ Furoscix (furosemide injection) for the treatment of congestion due to fluid overload among adults with chronic heart failure, the company announced.

With the approval, Furoscix becomes the first and only FDA-approved subcutaneous loop diuretic for the at-home treatment of congestion in heart failure.

The infusor enables subcutaneous administration at home by the patient or a caregiver. 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 80mg dose over five hours.

“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 US that will be able to self-administer IV equivalent diuresis at home,” said John Tucker, president and chief executive officer of scPharmaceuticals.

The at-home device delivers the equivalent of what a patient would receive by way of IV at a hospital, the company said. This was established in a clinical study in which Furoscix demonstrated 99.6% bioavailability and eight-hour urine output of 2.7L which was similar to subjects receiving intravenous furosemide.

Tucker also outlined the company’s plans to optimise commercialisation efforts to offer Furoscix to patients in the first quarter of 2023 with the goal of “driving rapid patient adoption to meet the needs of the $5.9bn addressable market in the US”.

John Mohr, Pharm.D, senior vice president, clinical development and medical affairs of scPharmaceuticals, said the product could “shift the treatment paradigm of how heart failure patients with congestion are treated and has the potential to become a new standard of care”.

“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,” Mohr said.

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