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Label indication FUROSCIX is indicated for the treatment of edema in pediatric patients weighing 43 kg and above and in adult patients adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. FDA label
Also known as Furosemide Injection Solution (SCP-101)
Furosemide · 2 trials · 2 indications
The volume of urine produced in milliliters over the 6 hours after drug delivery will be measured.
Assessment of pain will be conducted upon placement of the subcutaneous (SC) needle, upon activation of SC infusion and periodically during the infusion and post-infusion completion for up to 8 hours after the start of the infusion using a standardized 11 point pain scale. Score will range from 0 to 10, where zero is equivalent to no pain and 10 is equivalent to the worst possible pain.
| Arm | Type | Description |
|---|---|---|
| Furosemide Injection Solution, USP | ACTIVE_COMPARATOR | Single dose determined by Investigator (maximum dose 160mg) administered intravenously by IV bolus over approximately 2 minutes (reference treatment) |
| Furosemide Injection Solution (SCP-101) | EXPERIMENTAL | 80 mg dose administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours (test treatment) |
| Cohort One | EXPERIMENTAL | A bi-phasic delivery over 5 hours |
| Cohort 2a | EXPERIMENTAL | Continuous infusion over 2 hours |
| Cohort 2b | EXPERIMENTAL | Bi-phasic delivery over 2 hours |
| Cohort 3 | EXPERIMENTAL | Continuous infusion over 1 hour. |
| Cohort 4 | EXPERIMENTAL | Continuous infusion over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| Furosemide Injection Solution (SCP-101) | DRUG | - |
| Furosemide Injection Solution, USP | DRUG | - |
| Furosemide 80 mg (8 mg/mL) | DRUG | Furoscix will be administered as a subcutaneous infusion. |
Inclusion Criteria: * An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. * Male and female subjects \> 18 years of age * History of at least 3 months treated heart failure (NYHA class II/III/IV), or recent hospitalization for hea...
Furosemide is a small molecule diuretic being developed by MannKind Corporation for congestive heart failure and heart failure. It is intended to promote diuresis in patients with fluid overload. The development program includes a Phase 2 study comparing subcutaneous furosemide with intravenous furosemide in acute heart failure.
Furosemide targets SLC12A1, also known as the sodium-potassium-chloride cotransporter 2 (NKCC2), and acts as an inhibitor. By inhibiting this transporter in the kidney, furosemide increases excretion of sodium and water, which is the basis of its diuretic effect in heart failure.
MannKind Corporation, ticker MNKD, is developing Furosemide, including subcutaneous and oral formulations, for heart failure. The company is the sponsor of the clinical program, which includes a Phase 2 trial in acute heart failure and a Phase 1 study of a pH-neutral subcutaneous formulation.
Furosemide is in Phase 2 development for heart failure. It is investigational and has not been approved by the FDA for this use. The program includes one completed Phase 2 trial and one completed Phase 1 trial, with no active trials currently listed.
Furosemide has been studied in two completed trials. NCT02579057 was a Phase 2 study comparing subcutaneous versus intravenous furosemide in acute heart failure, enrolling 40 patients. NCT04161482 was a Phase 1 open-label study of a pH-neutral subcutaneous formulation in healthy volunteers, enrolling 39 participants.
Furosemide is also known as Furoscix, SCP-101, and various formulations including oral furosemide tablets (80 mg), furosemide 80 mg (8 mg/mL), furosemide injection USP, and furosemide injection solution. These names refer to the same active ingredient, furosemide, developed by MannKind Corporation.