The drug is indicated for congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure and is contraindicated for use in emergency situations or in patients with acute pulmonary oedema
Furoscix treats congestion related to chronic heart failure. (Credit: jesse orrico on Unsplash)
scPharmaceuticals, a US-based company focused on infused therapies, has secured the US Food and Drug Administration (FDA) approval for Furoscix to treat a type of heart failure.
Furoscix is a unique formulation of furosemide, which can be administered at home by the patient or a caregiver, using an On-Body Infusor that delivers a fixed dose of 80mg.
The drug is indicated for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.
The treatment is not advised for use in emergency situations or in patients with acute pulmonary oedema, said the company.
According to scPharmaceuticals, Furoscix is the first and only subcutaneous loop diuretic approved in the US, which delivers IV equivalent diuresis at home through an Infusor.
The On-Body Infusor for Furoscix was developed using West Pharmaceutical Services’ unique SmartDose On-Body drug delivery technology.
The system requires a pre-filled cartridge to be inserted into the pre-programmed single-use On-Body Infusor that is attached to the abdomen and is activated with the press of a button.
scPharmaceuticals president and chief executive officer John Tucker said: “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.
“We are preparing to optimise commercialisation 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 $5.9bn addressable market in the US.”
In a separate development, scPharmaceuticals has signed a binding term sheet with funds managed by Oaktree Capital Management (Oaktree) to secure a $100m debt facility.
The US drug maker intends to use the loan, along with cash on hand, to repay its debt under its existing loan and security agreement and to support the launch of Furoscix.
The potential transaction is subject to the execution of definitive agreements, which are expected to be signed by mid-October, and customary closing conditions.