CT001 (SedareRX™)
is a non-invasive intranasal formulation under development for administration by qualified healthcare professionals in controlled medical settings. The formulation combines two well-characterized analgesic agents that have long clinical histories of use in pediatrics and adults when administered by injection.
The intranasal formulation is being prepared by an FDA registered 503B Outsourcing Facility for use in acute and procedural pain management where needle-free administration may offer workflow and patient comfort advantages. The goal of this initiative is to provide clinicians with an additional option for pain management protocols, particularly in situations where intravenous access may be challenging or impractical.
The SeDare RX product is the subject of clinical evaluation by EMA in Europe, where hospital-based studies have explored its use in pediatric acute and procedural settings. These studies have focused on parameters such as administration feasibility, patient and caregiver preference, and observed tolerability.
Important Disclaimer: The clinical trial data presented on this website were generated during historical product development programs. This information does not constitute claims about the performance, safety, or efficacy of the compounded preparation available through our 503B facility. The compounded preparation is not FDA-approved and does not have an approved indication. This information is intended for healthcare professionals only to support education about compounded preparations made under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Clinical Information Sheet
Compounded Ketamine + Sufentanil Formulation
Prepared in an FDA-Registered 503B Outsourcing Manufacturing Facility
Sedare, Product Overview
Product Description
- Patented Formulation: Sterile compounded ketamine + sufentanil preparation
- Compounded by: STAQ Pharma an FDA-registered 503B outsourcing facility, compliant with cGMP
- Sterility & Quality: Each lot undergoes full sterility, endotoxin, and potency testing
- Stability: Beyond-use dating (BUD) established through validated stability studies
- Packaging: Nasal Spray, 2ml in two strengths based on patients’ weight
- Ordering: Available to only licensed practitioner or ordered for hospital/office use
Key Differentiators
- Consistent supply from a registered 503B facility – prepared under cGMP processes
- Rigorous quality controls and Certificates of Analysis (COAs) available
- Formulated to support hospital protocols for multimodal pain management strategies and for physician’s use.
Clinical Background for (Prescriber Audience)
Rationale for Combination (from literature)
Ketamine: Published literature describes ketamine as an NMDA receptor antagonist that has been studied in perioperative and acute pain settings. Research has documented opioid-sparing properties associated with ketamine use. [1) Assouline, B., Tramèr, M. R., Kreienbühl, L., & Elia, N. (2016). Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain: systematic review and meta-analyses of randomized controlled trials with trial sequential analyses. Pain, 157(12), 2854–2864. 2) Bell, R. F., Dahl, J. B., Moore, R. A., & Kalso, E. (2018). Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database of Systematic Reviews, (11), CD004603. 3) Brinck, E. C., Tiippana, E., Heesen, M., Bell, R. F., Straube, S., Moore, R. A., Kontinen, V. (2018). Perioperative intravenous ketamine for acute postoperative pain in adults. Cochrane Database Syst Rev. 12(12):CD012033. 4) Galili, S. F., Nikolajsen, L., & Papadomanolakis-Pakis, N. (2023). Subanaesthetic single-dose ketamine as an adjunct to opioid analgesics for acute pain management in the emergency department: a systematic review and meta-analysis. BMJ Open, 13(3), e066444.5) Cohen, B., Talmy, T., Gelikas, S., Radomislensky, I., Kontorovich-Chen, D., Cohen, B., Benov, A., Avital, G. (2022). Opioid sparing effect of ketamine in military prehospital pain management—a retrospective study. J Trauma Acute Care Surg. 93(2S Suppl 1):S71-S77. 6) Abdelfattah, M., Abdelbaser, I., Awad, K. A., Atallah, A. M., Sanad, M., Sayedalahl, M. (2024). Effect of Low-dose Ketamine Infusion on Opioid Consumption in Children Undergoing Open Cardiac Surgery: A Randomized Controlled Double-Blind Study. J Cardiothorac Vasc Anesth. 38(10):2349-2355. 7) Anghelescu, D. L., Ryan, S., Wu, D., Morgan, K. J., Patni, T., Li, Y. (2022). Low-dose ketamine infusions reduce opioid use in pediatric and young adult oncology patients. Pediatr Blood Cancer. 69(9):e29693.]
Sufentanil
Published literature describes sufentanil as a potent opioid analgesic that has been studied for its adjunctive role in pain management protocols. [ 8) Bovill, J. G., Sebel, P. S., Blackburn, C. L., Oei-Lim, V., Heykants, J. J. (1984). The pharmacokinetics of sufentanil in surgical patients. Anesthesiology. 61(5):502-6. 9) Blancher, M., Maignan, M., Clapé, C., Quesada, J-L., Collomb-Muret, R., Albasini, F., et al. (2019). Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med 16(7): e1002849.]
Ketamine + Sufentanil Combination
Published literature has documented the clinical use of ketamine and sufentanil in combination for analgesia. [ 10) Gottschalk, A., Freitag, M., Steinacker, E., Kreissl, S., Rempf, C., Staude, H. J., et al. (2008). Pre-incisional epidural ropivacaine, sufentanil, clonidine, and (S)+-ketamine does not provide pre-emptive analgesia in patients undergoing major pancreatic surgery. Br J Anaesth. 100(1):36-41. 11) Raza, S. M., Masters, R. W., Zsigmond, E. K. (1989). Haemodynamic stability with midazolam-ketamine-sufentanil analgesia in cardiac surgical patients. Can J Anaesth. 36(6):617-23. 12) Roelofse, J. A., Shipton, E. A., de la Harpe, C. J., Blignaut, R. J. (2004). Intranasal sufentanil/midazolam versus ketamine/midazolam for analgesia/sedation in the pediatric population prior to undergoing multiple dental extractions under general anesthesia: a prospective, double-blind, randomized comparison. Anesth Prog. 51(4):114-21. 13) Abrams, R., Morrison, J. E., Villasenor, A., Hencmann, D., Da Fonseca, M., Mueller, W. (1993). Safety and effectiveness of intranasal administration of sedative medications (ketamine, midazolam, or sufentanil) for urgent brief pediatric dental procedures. Anesth Prog. 40(3):63-6.
Multimodal Analgesia
Published literature supports multimodal analgesic approaches as strategies that may be considered in pain management protocols. [ 1) Assouline, B., Tramèr, M. R., Kreienbühl, L., & Elia, N. (2016). Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain: systematic review and meta-analyses of randomized controlled trials with trial sequential analyses. Pain, 157(12), 2854–2864.]
Summary of Clinical Studies for SeDare RX
*This information is provided for educational purposes only. This compounded preparation is not FDA-approved. Clinical decisions should be based on the independent judgment of the prescriber.
Study | Key Findings |
PDC 01-0201 (Nielsen et al., 2014) Procedural Pain Study N=50 pediatric patients (ages 1-17 years) | Open-label study examining procedural pain in hospital setting. Study documented procedural pain intensity scores and pharmacokinetic profiles in pediatric patients receiving intranasal sufentanil/ketamine. |
PDC 01-0202 Pivotal Pediatric Study N=155 pediatric patients (ages 1-17 years) | Open-label, multicenter study (7 sites: UK, Spain). Study documented that 88% of patients reported a Pain Intensity Score ≤4 after 30 min and 86.2% of participants achieved ≥50% pain reduction at 30 minutes and 92.8% at 60 minutes. Overall median pain reduction at 30 minutes was 75%. Study included 23.9% of participants who received a second dose. |
PDC 01-0203 (Nielsen et al 2024) Observational Registry N=1,057 total pediatric patients; n=300 combination (ages 1-17 years) | Real-world observational data from routine clinical practice. Study documented that median sufentanil dose was 38% lower when combined with ketamine compared to sufentanil monotherapy, while achieving similar pain intensity score reductions. |
PDC 01-0206 Procedural Pain Study N=25 pediatric patients (ages 1-17 years) | Open-label study examining procedural pain scenarios in children ages 1-17 years undergoing painful elective surgical procedures. Study documented that all subjects reached analgesic levels of sufentanil with median duration above threshold of 154 minutes. |
PDC 01-0206 Procedural Pain Study N=25 pediatric patients (ages 1-17 years) | Open-label study examining procedural pain scenarios in children ages 1-17 years undergoing painful elective surgical procedures. Study documented that all subjects reached analgesic levels of sufentanil with median duration above threshold of 154 minutes. |
PDC 01-0208 Modeling/Simulation Study | Pharmacokinetic/pharmacodynamic modeling and simulation study. Study used population modeling to predict efficacy endpoints for pediatric patients across different weight categories. Model simulations predicted 84% would achieve ≥50% pain reduction at 30 minutes, with an overall 82% median pain reduction at 30 min. In absence of ketamine, simulation estimated that sufentanil exposure would need to be tripled to achieve similar effect |
PDC 01-0205 Adult Dental Study N=220 adults (18-55 years) | Double-blind, randomized, placebo-controlled study examining acute postoperative pain following dental surgery. Pharmacokinetic/pharmacodynamic modeling from this study documented an opioid-sparing effect of ketamine, with modeling indicating that sufentanil exposure would need to be increased by 50-100% in the absence of ketamine to achieve similar analgesic effects. |
(Full reference list available on request)
*503B Disclosure Statement:
Sedare is compounded by an FDA-registered 503B Outsourcing Manufacturing Facility. Sedare is prepared under Section 503B of the Federal Food, Drug, and Cosmetic Act. Sedare is for use by licensed healthcare professionals only. Not for patient dispensing. This material is intended for informational and educational purposes only and is not intended as medical advice. Distribution is limited to healthcare facilities ordering directly from an FDA-registered 503B Outsourcing Facility. STAQ Pharma, a 503B facility operates under current Good Manufacturing Practice (cGMP) standards and is routinely inspected by the FDA and State Board of Pharmacy. This compounded preparation is not approved by the U.S. Food and Drug Administration (FDA).
LONG-LASTING
Paradigm shift in
regional anesthesia
SAFE
COST-EFFECTIVE
Trusted partner
As the developer of certain patented formulations, Ventis Pharma has provided RX the license to manufacture the Endura-KT formulation under its FDA 503B Outsourcing facility. RX is a licensed FDA 503B Outsourcing Facility where all products are manufactured in the USA according to FDA CGMP regulations
