TIVORBEX, a nonsteroidal anti-inflammatory drug (NSAID) developed by Iroko Pharmaceuticals, has made significant strides in the treatment of mild to moderate acute pain in adults. This article provides a comprehensive overview of TIVORBEX's clinical trials, market analysis, and future projections.
Understanding TIVORBEX
TIVORBEX (indomethacin) is an FDA-approved NSAID designed to treat mild to moderate acute pain in adults. It utilizes proprietary SoluMatrix Fine Particle Technology™, which reduces the particle size of indomethacin to approximately 20 times smaller than its original size[1].
Mechanism of Action
TIVORBEX works by inhibiting the cyclooxygenase (COX-1 and COX-2) pathway, providing relief from inflammation and pain[9]. The reduced particle size increases the surface area, leading to faster dissolution and potentially quicker pain relief.
Clinical Trials Overview
The FDA approval of TIVORBEX was based on two pivotal Phase 3 clinical trials involving patients with post-surgical acute pain[1][9].
Study Design
Both trials were randomized, double-blind, and multicentre studies. They enrolled a total of 835 patients experiencing significant post-surgical pain[9].
Dosage and Administration
Patients were administered one of the following:
- TIVORBEX 20 mg three times daily
- TIVORBEX 40 mg twice daily
- TIVORBEX 40 mg three times daily
- Placebo
Key Findings
"About half as many opioid-containing rescue medication tablets were used in the TIVORBEX arms compared to the placebo group over 48 hours."[1]
This significant reduction in opioid use highlights TIVORBEX's potential as a valuable treatment option for acute pain management.
Efficacy Results
Both clinical studies demonstrated that TIVORBEX was effective in reducing pain intensity compared to placebo[9].
Pain Intensity Reduction
Patients receiving TIVORBEX at all tested dosages (20 mg three times daily, 40 mg twice daily, and 40 mg three times daily) showed significant improvement in pain relief compared to those receiving placebo[1].
Onset of Action
The median time to onset of pain relief was under one hour for patients randomized to TIVORBEX[2], indicating rapid effectiveness.
Safety Profile
Common Adverse Reactions
The most frequent adverse events occurring in at least 5% of patients in TIVORBEX or placebo treatment groups were[3]:
- Edema
- Nausea
- Headache
- Dizziness
- Vomiting
- Hematoma
- Constipation
Cardiovascular Risk
As with other NSAIDs, TIVORBEX may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke[1]. This risk may increase with duration of use and in patients with cardiovascular disease or risk factors.
Market Analysis
Current Market Size
The global Axial Spondyloarthritis (axSpA) market, which includes treatments like TIVORBEX, was valued at USD 5.2 billion in 2021[6].
Market Projections
The axSpA market is expected to reach USD 10.1 billion by 2032, growing at a CAGR of 6.86% during the forecast period of 2022 to 2032[6].
Regional Analysis
North America currently holds the largest market share in the global axSpA market[7]. However, Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029)[7].
Competitive Landscape
Key Players
Major companies operating in the axSpA market include[7]:
- Janssen Biotech
- AbbVie
- UCB
- Amgen
- Novartis Pharmaceuticals Corporation
TIVORBEX's Position
TIVORBEX, as a lower-dose NSAID, offers a unique selling proposition in the crowded pain management market. Its ability to provide effective pain relief while potentially reducing opioid use positions it favorably among competitors.
Future Outlook
Market Drivers
Several factors are expected to drive the growth of the axSpA market, including:
- Increasing prevalence of axSpA
- Growing awareness about the condition
- Advancements in diagnostic techniques
- Introduction of novel therapies
Challenges
Despite the positive outlook, the market faces challenges such as:
- High cost of biologics
- Stringent regulatory requirements
- Side effects associated with long-term use of NSAIDs
Impact on Pain Management
TIVORBEX's approval at lower dosage strengths than traditional indomethacin products aligns with FDA recommendations to use NSAIDs at the lowest effective dose for the shortest possible duration[1].
Opioid Use Reduction
The significant reduction in opioid rescue medication use observed in TIVORBEX clinical trials suggests its potential in addressing the ongoing opioid crisis[1].
Patient Access and Reimbursement
Increasing healthcare spending and favorable reimbursement policies are expected to improve patient access to treatments like TIVORBEX, potentially driving market growth[6].
Research and Development Pipeline
While specific information about TIVORBEX's ongoing research is limited, the broader axSpA market is seeing continuous R&D efforts to develop more effective and safer treatments.
Global Market Trends
The therapeutic market for acute pain in the seven major markets (7MM) was valued at USD 1,962.02 million in 2017[10]. The United States accounted for the largest share, followed by Germany among EU-5 countries.
Regulatory Landscape
TIVORBEX received FDA approval in February 2014[5]. Its development aligns with FDA and professional organizations' recommendations for lower-dose NSAID options in pain management.
Key Takeaways
- TIVORBEX, a lower-dose NSAID, has demonstrated efficacy in treating mild to moderate acute pain in adults.
- Clinical trials showed significant pain relief and reduced need for opioid rescue medication compared to placebo.
- The global axSpA market, which includes treatments like TIVORBEX, is projected to reach USD 10.1 billion by 2032.
- North America currently leads the market, but Asia-Pacific is expected to show the highest growth rate.
- TIVORBEX's lower dosage aligns with FDA recommendations and may help address the opioid crisis.
- The drug's unique formulation using SoluMatrix Fine Particle Technology™ offers potential advantages in onset and duration of action.
- As with all NSAIDs, TIVORBEX carries cardiovascular risks that need to be considered in treatment decisions.
FAQs
-
What makes TIVORBEX different from other NSAIDs?
TIVORBEX uses proprietary SoluMatrix Fine Particle Technology™, which reduces the particle size of indomethacin, potentially leading to faster dissolution and absorption.
-
How effective is TIVORBEX in reducing opioid use?
Clinical trials showed that patients using TIVORBEX required about half as many opioid-containing rescue medication tablets compared to the placebo group over 48 hours.
-
What are the main side effects of TIVORBEX?
Common side effects include edema, nausea, headache, dizziness, vomiting, hematoma, and constipation.
-
How does TIVORBEX fit into the current pain management landscape?
TIVORBEX offers a lower-dose NSAID option for acute pain management, aligning with FDA recommendations to use the lowest effective dose of NSAIDs.
-
What is the projected market growth for treatments like TIVORBEX?
The global axSpA market, which includes treatments like TIVORBEX, is expected to grow at a CAGR of 6.86% from 2022 to 2032, reaching USD 10.1 billion by 2032.
Sources cited:
- https://www.biospace.com/iroko-pharmaceuticals-announces-new-results-from-solumatrix-and-0174-nsaid-portfolio-in-acute-pain-and-osteoarthritis
- https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204768Orig1s000SumR.pdf
- https://www.rxlist.com/tivorbex-drug.htm
- https://www.fiercepharma.com/pharma/iroko-pharmaceuticals-receives-fda-approval-for-tivorbex%E2%84%A2
- https://www.sphericalinsights.com/reports/axial-spondyloarthritis-axspa-market
- https://www.mordorintelligence.com/industry-reports/global-axial-spondyloarthritis-market
- https://www.clinicaltrialsarena.com/projects/tivorbex-indomethacin-for-the-treatment-of-acute-pain/
- https://www.prnewswire.com/news-releases/global-acute-pain-market-insights-epidemiology-and-market-forecast-to-2028-300927702.html
