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Sprix
Sprix, developed by the University of Louisville, is a marketed drug with a key composition patent expiring in 2028. The drug's market position and primary indication are not specified, but it holds a competitive advantage due to its patent protection. The primary risk is the potential increase in competition post-patent expiry in 2028.
At a glance
| Generic name | Sprix |
|---|---|
| Also known as | Intranasal Ketorolac, SPRIX (intranasal ketorolac tromethemine) |
| Sponsor | University of Louisville |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [ see Warnings and Precautions ( 5.1 ) ]. SPRIX ® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contra
Common side effects
- Nasal discomfort
- Rhinalgia (nasal pain)
- Increased lacrimation
- Throat irritation
- Oliguria
- Rash
- Bradycardia
- Decreased urine output
- Increased ALT and/or AST
- Hypertension
- Rhinitis
Serious adverse events
- Bleeding at operative site
- Hematoma at operative site
- GI ulceration
- GI perforation
- Postoperative bleeding
- Acute renal failure
- Anaphylactic reactions
- Anaphylactoid reactions
- Liver failure
- Hepatitis
Key clinical trials
- Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction (PHASE2, PHASE3)
- The Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA (NA)
- Comparison of Pain Reduction in Painful Chronic Wounds With and Without Fat Grafting (NA)
- Low-Dose Short-Term Ketorolac to Reduce Chronic Opioid Use in Orthopaedic Polytrauma Patients (PHASE4)
- NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis (PHASE3)
- Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries (NA)
- Anesthetics and Analgesics in Children
- INflammatory MediatorS in the PathophysIology of Diabetic REtinopathy Study (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sprix CI brief — competitive landscape report
- Sprix updates RSS · CI watch RSS
- University of Louisville portfolio CI