NDAORALTABLET
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
2/8 — Basic
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Bextra (valdecoxib) is a selective COX-2 inhibitor oral tablet approved by the FDA in 2001 for pain and inflammation management. It was developed as part of the coxib class of NSAIDs, offering targeted anti-inflammatory activity. The product is now in late-stage lifecycle with loss of exclusivity approaching.
LOE Approaching
As LOE approaches, the commercial team is likely in defensive/transition mode with reduced headcount and focus on managed care retention rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers
Started Aug 2004
20 enrolled
PainHyperalgesia
A Multicenter, Open Label Trial To Evaluate Pain Relief With Intravenous Followed By Oral Therapy With Parecoxib/Valdecoxib 40 Mg/Day For Treatment Of Post-Laparoscopic Surgery Pain
Started Jun 2004
4 enrolled
Pain, Post Surgical
Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee
Started May 2004
265 enrolled
OsteoarthritisKnee
A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction
Started Mar 2004
328 enrolled
Pain, Postoperative
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction
Started Mar 2004
488 enrolled
Pain
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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.