SeDare Nasal Spary
A revolutionary way to treat pediatric and adult pain is just a spray away.
SUFentanil/Ketamine nasal spray, solution
60 mcg/mL + 60 mg/mL (green cap) · 90 mcg/mL + 90 mg/mL (purple cap)
Enhanced analgesic and opioid exposure sparing effect
Sufentanil is a potent synthetic opioid often used in the management of severe pain. When used alongside ketamine, it provides a more robust pain management solution than either agent alone. This combination allows for lower opioid exposure to achieve a similar reduction in pain, resulting in a high success rate of completed procedures.1,3,8,9,10
Respiratory impact
Ketamine has been shown to be a respiratory stimulant that increases inspiratory flow, minute ventilation and upper airway dilator muscle. These properties make ketamine advantageous for preserving breathing and airway patency during anesthesia and ICU sedation.4,5,6,7 In simulations, minimum minute ventilation at the proposed posology was 93.2% (82.8%/97.8%), with 0.04% of children below the 70% critical threshold. Matching the same 30 minute pain reduction with sufentanil alone requires around three-fold higher exposure and places 11.3% below that threshold.9
Improved safety profile
The lower dose of ketamine in the fixed combination mitigates the risk of ketamine-induced hallucinations, confusion, and dissociative effects while providing adequate analgesia. This advantage is particularly important in pediatric settings.2, 3, 12
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. Administered through a metered-dose nasal spray device, Sedare offers a needle-free approach that does not require intravenous access, infusion equipment, or the time and resources associated with establishing an IV line.
Designed for use in acute-care settings, Sedare provides clinicians with a convenient intranasal administration option when rapid, practical drug delivery is important.
Sedare is a compounded preparation supplied by an FDA-registered 503B outsourcing facility and manufactured in accordance with applicable current Good Manufacturing Practice (cGMP) requirements. Each lot undergoes quality testing, including testing for sterility, bacterial endotoxins, and potency.
- Patented Formulation: Sterile compounded ketamine + sufentanil preparation
- Compounded by: By a FDA Registered 503B Manufacturer 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
fits in the practice
Emergency Department
Intranasal delivery allows analgesia to begin at triage or at the bedside without waiting for an IV (not a line), which matters most in patients with difficult IV access and in children who are distressed by an IV start.
EMS & Pre-Hospital Care
A metered nasal pump can be carried, stored, and administered without infusion equipment, in settings where establishing intravenous access is impractical.
Burn Dressing Changes
Where vascular access may be limited by the injury itself and changes are repeated daily or more often
Laceration Repair
Pediatric urgent care centers
Fracture Reduction
Orthopedic offices
Wound Debridement
Wound care centers
Abscess Incision and Drainage
Incision and drainage of an abscess in a general surgeon’s office.
About Us
Ventis Pharma Corporation strives to become a world leader in advancing pain management solutions. Our innovative, long-acting, low-toxicity formulations are designed to reduce surgical pain and treat chronic pain conditions safely and effectively. By making our formulations cost-effective and available throughout the world, we can improve the quality of life for all patients. Endura-KT is cost-efficient and may provide an effective alternative to opioids.
Patents
Countries have granted or are currently reviewing patents
Global Presence
Ventis Pharma has received patents, and has patents pending, in more than 40 countries. With the help of Enduracaine™, we can provide superior analgesic solutions to patients undergoing more than 350 million surgeries a year.
Cost-effective
Delivering cost-effective formulations globally
Who is Ventis Pharma?
Ventis Pharma is dedicated to providing healthcare professionals with high-quality compounded preparations produced under Section 503B of the Federal Food, Drug, and Cosmetic Act.
Dental Solutions
Products that meet the clinical needs of oral and maxillofacial practitioners
Supporting Dental Professionals with Advanced Compounded Solutions
Our Dental Division focuses on offering products that meet the clinical needs of oral and maxillofacial practitioners seeking consistent quality and dependable performance.
1. Assouline, B., Tramèr, M.R., Kreienbühl, L. and Elia, N., 2016. Benefit and harm of adding ketamine to an opioid in a patient-controlled analgesia device for the control of postoperative pain. PAIN, 157(12), pp.2854-2864.
2. Study 0201: Nielsen, B.N., Friis, S.M., Rømsing, J., Schmiegelow, K., Anderson, B.J., Ferreirós, N., Labocha, S. and Henneberg, S.W., 2014. Intranasal sufentanil/ketamine analgesia in children. Pediatric Anesthesia, 24(2), pp.170-180.
3. Registry Study 0203: Henneberg, S.W., 2023. A registry study of pharmacovigilance of intranasal sufentanil and S-ketamine in a paediatric cohort (1-17 years), PDC 01-0203: Clinical Study Report. Copenhagen University Hospital.
4. Mildh, L., Taittonen, M., Leino, K. and Kirvelä, O., 1998. The effect of low-dose ketamine on fentanyl-induced respiratory depression. Anaesthesia, 53(10), pp.965-970.
5. Suleiman, A., Santer, P., Munoz-Acuna, R., et al., 2022. Effects of Ketamine Infusion on Breathing and Encephalography in Spontaneously Breathing ICU Patients. Journal of Intensive Care Medicine, 38(3), pp.299-306.
6. Eikermann, M., Grosse-Sundrup, M., Zaremba, S., et al., 2012. Ketamine activates breathing and abolishes the coupling between loss of consciousness and upper airway dilator muscle dysfunction. Anesthesiology, 116(1), pp.35-46.
7. Mion, G. and Villevieille, T., 2013. Ketamine pharmacology: an update. CNS Neuroscience & Therapeutics, 19(6), pp.370-380.
8. Study 0205. Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and the Fixed Combination after Impacted Mandibular Third Molar Extraction.
9. Study 0207 & 0208. A population PK model combining adult and paediatric data, used to support the proposed dosage regimens. Incl. Addendum to the PDC 01-0207 and PDC 01-0208 reports with additional population PK modelling results and simulation of effects and side effects, Occams 2115, 10 June 2026.
10. Galili, S.F., Nikolajsen, L. and Papadomanolakis-Pakis, N., 2023. Subanaesthetic single-dose ketamine as an adjunct to opioid analgesics for acute pain management in the emergency department. BMJ Open, 13(3), p.e066444.
11. Study 0204: Bioavailability study of intranasal sufentanil/ketamine fixed combination in healthy volunteers [Clinical Study Report], 2022.
12. Study 0206: Pharmacokinetic study of intranasal sufentanil/ketamine fixed combination in children 1-17 years of age undergoing elective surgical procedures, PDC 01-0206, 2023.
13. Study 0202: Open-label, prospective study to assess the safety, tolerability, analgesic effect and feasibility of intranasal sufentanil/ketamine in pediatric patients with moderate or severe pain, in an acute care setting, PDC 01-0202: Clinical Study Report v1.0, 03 July 2025.