SeDare™ Nasal Spray
Intranasal sufentanil and ketamine, fixed combination
Sedare™ (CT001) is a fixed-dose combination of sufentanil and ketamine formulated as an intranasal spray for the management of moderate-to-severe acute pain. Delivered through a metered-dose nasal spray device, Sedare requires no intravenous access, needles, or infusion equipment.
Sedare is a compounded preparation supplied by an FDA-registered 503B outsourcing facility and produced in accordance with applicable current Good Manufacturing Practice (cGMP) requirements. Each lot undergoes quality testing, including testing for sterility, bacterial endotoxins, and potency.
Dosing Information
The target dose is 0.5 micrograms per kilogram sufentanil with 0.5 milligrams per kilogram ketamine, delivered by weight band as a single dose of two to four actuations of the 60/60 strength, or two to three actuations of the 90/90 strength, with a second dose if needed. Two strengths exist so that the same product can be dosed by weight across a wide range of patient sizes without changing the delivery volume beyond what the nasal cavity will hold.
Source: Dosing and presentation figures as stated to the Food and Drug Administration under pre-Investigational New Drug application 157772 and recorded in the minutes of the Type B pre-IND meeting of January 24, 2022; device configuration per Study PDC 01-0206.
60 mcg/mL SUFentanil +
60 mg/mL Ketamine
Label and cap color: Green
90 mcg/mL SUFentanil +
90 mg/mL Ketamine
Label and cap color: Purple