Clinical Information
The clinical rationale is that pairing a potent short-acting opioid with a sub-dissociative dose of ketamine allows meaningful analgesia at lower opioid exposure than opioid alone. Two separate kinds of evidence support that. In the adult controlled trial, matched on measured drug exposure, the combination delivered analgesia comparable to sufentanil alone at approximately 2.7-fold lower sufentanil exposure. In the pediatric registry, an observational record of routine care, median sufentanil doses were 38 percent lower when S-ketamine was added. The first is an exposure-controlled finding; the second is an observed dosing pattern.
Pivotal Efficacy: Study PDC 01-0202
88%
reached pain score of 4 or less within 30 minutes
54%
reached that threshold by 15 minutes
75%
median pain reduction at 30 minutes
85.7%
median pain reduction at 60 minutes
Pivotal Results from the PDC 01-0202 Study
Analgesic Effect and Tolerability of a Novel Sufentanil/Ketamine Nasal Spray (CT001) in Pediatric Acute Pain: Pivotal Results from the PDC 01-0202 Study Validating a Model-Informed Approach
Primary Endpoint Painscores
Primary Endpoint at 15 min
(n=82/152)
Primary Endpoint at 30 min
(n=134/152)