NDAOPHTHALMICSOLUTION/DROPS
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
6
Data completeness
6/8 — Strong
ACUVAIL (ketorolac tromethamine) by AbbVie is anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. First approved in 2009.
Drug data last refreshed 3h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACUVAIL is a ketorolac tromethamine ophthalmic solution approved in 2009 for ocular pain and inflammation. It is a nonsteroidal anti-inflammatory drug (NSAID) that works by inhibiting prostaglandin biosynthesis. The product is administered as eye drops to patients requiring post-operative or allergic ocular pain management.
$0.174MPart D
PeakStable
3.1 years to LOEProduct is in peak lifecycle stage with modest Medicare utilization; brand team likely focused on maintaining market share in a competitive ophthalmology segment.
Mechanism of Action
anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Started Mar 2013
78 enrolled
Back Pain
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Started Mar 2013
83 enrolled
Back Pain
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Started Dec 2010
129 enrolled
Rhinitis, Allergic, SeasonalConjunctivitis, Allergic
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Started Aug 2010
10 enrolled
Must be PRK Candidate
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Started Oct 2009
126 enrolled
Cataracts
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.