SPRIX (ketorolac tromethamine)
SPRIX helps adult patients manage moderate to moderately severe pain that is intense enough to require opioid-level relief. It is used for short-term care, specifically for periods of five days or less. This medication provides a potent nonsteroidal anti-inflammatory option for those needing significant pain management for brief durations.
How SPRIX Works
This medication works by blocking the COX-1 and COX-2 enzymes, which reduces the body's production of prostaglandins, thromboxanes, and prostacyclin. Since prostaglandins normally sensitize nerves to pain and drive inflammation, lowering their levels in peripheral tissues helps reduce pain and swelling.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-05-14
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
SPRIX Approval History
What SPRIX Treats
1 indicationsSPRIX is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
SPRIX Boxed 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 Contraindicatio...
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 Contraindications ( 4 ) and Warnings and Precautions ( 5.1 ) ]. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [ see Warnings and Precautions ( 5.2 ) ]. WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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 ( 5.1 ) SPRIX ® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery ( 4 , 5.1 ) NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events ( 5.2 )
SPRIX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SPRIX
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
37 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05324358 | NTM-001-CT001 | Ph 3 | suspended | Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy |
| NCT06513208 | HP-00109853 | Ph 4 | recruiting | Ketorolac Effects on Post-operative Pain and Lumbar Fusion |
| NCT05641363 KETODOSE | KETODOSE20221107 | Ph 3 | completed | Comparison of Ketorolac at Three Doses in Children With Acute Pain |
| NCT03913702 results posted | UTMB IRB #: 18-0156 | Ph 2 | terminated | Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement |
| NCT03453541 | 4923 | Ph 4 | terminated | Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy |
| NCT04733326 | CairoU0 | Ph 1 | completed | Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial. |
| NCT06395428 | WMed-2024-1032 | Ph 4 | recruiting | Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department |
| NCT06160778 KETOAPP | 23-0952 | Ph 3 | recruiting | Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain |
| NCT04666701 | EMS1319 - ESCÓCIA | Ph 2 | withdrawn | Efficacy and Safety of Escócia Association in the Treatment of Acute Pain |
| NCT05382546 | NTM-001-AHC001 | Ph 1 | completed | A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects |
| NCT04439396 | 19-387 | Ph 1 | completed | Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use |
| NCT04554862 | M419 | Ph 4 | completed | The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block |
| NCT04939987 | IRB00074034 | Ph 2, Ph 3 | withdrawn | Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy |
| NCT04444830 | 19.1351 | Ph 4 | withdrawn | Sprix for Postoperative Pain Control Following Gynecologic Surgery |
| NCT01471899 | CTRGEMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT01471886 | CTREMS0611 | Ph 3 | completed | Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment |
| NCT02902770 results posted | 2016-03-09 | Ph 4 | completed | Intravenous Lidocaine and Ketorolac for Pain Management |
| NCT02923687 | AZadUMS-P/190/D | Ph 2 | completed | Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain |
| NCT03410212 IANB | IR.IAU.DENTAL.REC.1396,31 | Ph 2 | completed | Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain |
| NCT02658149 results posted | 2015-422 | Ph 4 | completed | Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty |
| NCT02313675 results posted | PRO14110464 | Ph 4 | completed | Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries |
| NCT03007381 KANGAROO | KANGAROO | Ph 4 | withdrawn | Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn |
| NCT02638831 | DRL_RUS/PMS/2012/KETG | Ph 4 | completed | Ketorol Gel in Gonarthrosis and Low Back Pain |
| NCT02729285 | 2014MEKY042 | Ph 4 | completed | Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery |
| NCT02601911 | AzadUMS P/66/D | Ph 2 | completed | Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection |
| NCT02614118 | AZadUMS-P/139/D | Ph 2 | completed | Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain |
| NCT02536430 | AZadUMS-P/212/D | Ph 2 | completed | Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block |
| NCT01819610 | 1SPR11001 | Ph 3 | completed | Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures |
| NCT00907114 | HJM 1667/09.03.24 | Ph 2 | completed | Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy |
| NCT01596166 EDMigraine-4 | EDMIGR-004-01 | Ph 4 | completed | Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department |
| NCT01542190 | 0018014600011 | Ph 4 | completed | Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery |
| NCT02000401 | 0703-2012-SPRIX | Ph 4 | completed | Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain |
| NCT01365624 results posted | ROX 2007-02 | Ph 1 | completed | Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects |
| NCT01436032 | N1539-05 | Ph 3 | terminated | Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery |
| NCT01291472 | 3214 2011-000367-27 | Ph 4 | completed | Disposition of Intravenous Ketorolac |
| NCT01015235 | KAI-1678-002 | Ph 2 | completed | Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain |
| NCT01021761 results posted | 2009 0199 | Ph 4 | completed | A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SPRIX FDA Label Details
Indications & Usage
FDA Label (PDF)SPRIX is indicated for the treatment of Pain.
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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment