FUROSCIX® is an investigational, proprietary formulation of furosemide that is designed to be administered by subcutaneous infusion via a wearable on-body, drug delivery system. It is being evaluated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization.

Given the current landscape for the management of congestion in patients with heart failure, we saw an opportunity to investigate an alternative approach to treatment and began exploring the possibility of delivering furosemide subcutaneously via an on-body infusor.

FUROSCIX® is not approved for use by any regulatory agency. The FUROSCIX Prescription Drug User Fee Act (PDUFA) date is December 30, 2020.

Leveraging subcutaneous on-body delivery technology.

FUROSCIX® pairs our investigational formulation of furosemide with West Pharmaceutical Services, Inc.’s SmartDose® Generation II (Gen. II) on-body drug delivery system.

The SmartDose1 Gen. II device is being evaluated as a fully integrated, single-use subcutaneous drug delivery system with a pre-filled cartridge, a pre-programmed drug delivery profile, and visual, tactile, and audible feedback alarms.

1 SmartDose® and the external product configuration of West’s SmartDose® drug delivery platform are the intellectual property of West Pharmaceutical Services, Inc. or one of its subsidiaries, in the United States and other countries.