ScPharmaceuticals finally wins FDA nod for its on-body infusor for congestive heart failure

After five years and two unsuccessful attempts, scPharmaceuticals has finally pushed its on-body infusor for congestive heart failure across the FDA finish line.

With the approval, Furoscix becomes the first self-administered, subcutaneous loop diuretic for those with worsening HF. The infusor delivers generic furosemide, which relieves fluid retention and swelling that accompanies HF and other conditions such as liver and kidney disease.    

The at-home device provides the equivalent of what a patient would receive by way of IV at a hospital, the company said. There are more than 7 million people with HF in the U.S. and many are prone to hospitalization for congestion as they have become resistant to oral diuretics.

ScPharmaceuticals will launch Furoscix 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.,” CEO John Tucker said in a Monday release.

Clinical study of Furoscix showed 99.6% bioavailability equivalence with IV, the company said, with a similar diuretic profile, as measured by urine production and sodium excretion.

The SmartDose delivery technology was developed by West Pharmaceutical Services. It consists of a pre-filled cartridge, inserted into a single-use infusor, which attaches to the abdomen. The device is activated by the press of a button, delivering an 80 mg dose over five hours.

The company believes the product could change the “paradigm of how heart failure patients with congestion are treated and has the potential to become a new standard of care,” said John Mohr, the organization’s clinical development and medical affairs chief said.

The endorsement comes after considerable trial and error; scPharmaceuticals originally sought approval for the product in 2017, but that attempt was knocked back as the FDA demanded modifications to the device and additional validation studies. Then in 2020, the company received a second complete response letter that cited manufacturing issues and questions about testing and labeling.