CLINICAL TRIALS PROFILE FOR ZORVOLEX

All Clinical Trials for ZORVOLEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03949673 ↗	Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip	Terminated	Teva Pharmaceutical Industries, Ltd.	Phase 2	2019-04-08	The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).
NCT03949673 ↗	Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip	Terminated	Regeneron Pharmaceuticals	Phase 2	2019-04-08	The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).
NCT03304379 ↗	Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip	Completed	Teva Pharmaceutical Industries, Ltd.	Phase 3	2017-10-26	The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: - To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip - To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
NCT03304379 ↗	Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip	Completed	Regeneron Pharmaceuticals	Phase 3	2017-10-26	The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: - To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip - To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

Clinical Trial Conditions for ZORVOLEX

Condition Name

Condition Name for ZORVOLEX
Intervention	Trials
Osteoarthritis, Hip	2
Osteoarthritis, Knee	2

Condition MeSH

Condition MeSH for ZORVOLEX
Intervention	Trials
Osteoarthritis	2
Osteoarthritis, Knee	2
Osteoarthritis, Hip	2

Clinical Trial Locations for ZORVOLEX

Trials by Country

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Trials by Country for ZORVOLEX
Location	Trials
United States	47
United Kingdom	13
Poland	7

Trials by US State

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−

Trials by US State for ZORVOLEX
Location	Trials
Texas	2
South Carolina	2
Pennsylvania	2
Ohio	2
New York	2

Clinical Trial Progress for ZORVOLEX

Clinical Trial Phase

Clinical Trial Phase for ZORVOLEX
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ZORVOLEX
Clinical Trial Phase	Trials
Completed	1
Terminated	1

Clinical Trial Sponsors for ZORVOLEX

Sponsor Name

Sponsor Name for ZORVOLEX
Sponsor	Trials
Teva Pharmaceutical Industries, Ltd.	2
Regeneron Pharmaceuticals	2

Sponsor Type

Sponsor Type for ZORVOLEX
Sponsor	Trials
Industry	4

ZORVOLEX (Diclofenac): Clinical Trials, Market Analysis, and Projections

Introduction

ZORVOLEX, a nonsteroidal anti-inflammatory drug (NSAID) developed by Iroko Pharmaceuticals, has been a significant player in the treatment of mild to moderate acute pain and osteoarthritis pain. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Phase III Clinical Trials for Acute Pain

The FDA approval of ZORVOLEX for the treatment of mild to moderate acute pain was based on a randomized, multicentre, double-blind, placebo-controlled, parallel-arm phase III clinical study. This study enrolled 428 patients with moderate to severe pain following surgical bunionectomy. Patients were randomly administered ZORVOLEX 18mg or 35mg three times a day, celecoxib 400mg loading dose followed by 200mg twice daily, or placebo. The primary endpoint was the combined differences in pain intensity over 0 to 48 hours, measured using the visual analog scale (VAS). The results showed significant pain relief in patients treated with ZORVOLEX compared to placebo[1].

Phase III Clinical Trials for Osteoarthritis

For osteoarthritis pain, Iroko Pharmaceuticals conducted several clinical trials. A 12-week, double-blind, placebo-controlled phase III study involved 202 patients with osteoarthritis pain of the knee or hip. This study assessed the efficacy and safety of ZORVOLEX 35mg twice daily. The most frequent adverse reactions included diarrhoea, headache, nausea, and upper respiratory tract infection[3].

A longer-term, 52-week, open-label phase III study evaluated ZORVOLEX in 601 patients with knee or hip osteoarthritis. Patients received ZORVOLEX 35mg either twice or three times daily. The study found that ZORVOLEX was generally well tolerated and improved health-related quality of life (HRQOL) in patients. Common adverse events included upper respiratory tract infection, headache, and urinary tract infection[4].

Market Analysis

Current Market Position

ZORVOLEX is part of the broader non-opioid pain treatment market, which is experiencing significant growth. The global non-opioid pain treatment market was estimated at USD 45.32 billion in 2024 and is projected to grow at a CAGR of 7.69% from 2025 to 2030[2].

Insurance Coverage and Regulatory Support

Insurance companies are increasingly expanding coverage for non-opioid pain management therapies, recognizing their long-term benefits and cost savings compared to opioids. This trend is expected to boost the market for drugs like ZORVOLEX. For example, the inclusion of ZYNRELEF (bupivacaine and meloxicam) in Medicare's payment systems highlights the growing support for non-opioid pain relief options[2].

Market Projections

Growth Drivers

The non-opioid pain treatment market is driven by several factors, including the rising approval and launch of new medications, increased insurance coverage, and a growing awareness of the risks associated with opioid use. The injectable segment, in particular, is expected to experience lucrative growth due to new product launches and approvals[2].

Competitive Landscape

ZORVOLEX, with its unique SoluMatrix Fine Particle Technology, which reduces the particle size of diclofenac to approximately 20 times smaller than its original size, offers faster dissolution and potentially better efficacy. This technology, combined with the drug's low-dose formulation, positions ZORVOLEX favorably in the market[4].

Long-Term Safety and Quality of Life

Long-Term Studies

The 12-month, open-label phase III study on ZORVOLEX in patients with osteoarthritis demonstrated that the drug was generally well tolerated and improved HRQOL. Patients reported clinically meaningful improvements in the Physical Component Score of the Short Form-36 (SF-36v2) health-related quality of life assessment tool[4].

Adverse Events

While ZORVOLEX has shown a favorable safety profile, common adverse events include upper respiratory tract infection, headache, and urinary tract infection. Serious adverse events, such as myocardial infarction and gastrointestinal ulcer, were rare and not considered related to the study medication[4].

Key Takeaways

• Clinical Efficacy: ZORVOLEX has demonstrated significant pain relief in clinical trials for both acute pain and osteoarthritis.
• Market Growth: The non-opioid pain treatment market is projected to grow at a CAGR of 7.69% from 2025 to 2030, driven by new product approvals and increased insurance coverage.
• Long-Term Safety: ZORVOLEX has shown a favorable long-term safety profile and improves health-related quality of life in patients with osteoarthritis.
• Competitive Advantage: The unique SoluMatrix Fine Particle Technology of ZORVOLEX offers faster dissolution and potentially better efficacy.

FAQs

What is ZORVOLEX used for?

ZORVOLEX is used for the treatment of mild to moderate acute pain and osteoarthritis pain in adults[1].

What is the dosage of ZORVOLEX for acute pain?

The dosage for mild to moderate acute pain is 18mg or 35mg orally three times daily[4].

What is the unique technology behind ZORVOLEX?

ZORVOLEX uses SoluMatrix Fine Particle Technology, which reduces the particle size of diclofenac to approximately 20 times smaller than its original size, leading to faster dissolution[4].

What were the common adverse events reported in clinical trials of ZORVOLEX?

Common adverse events included upper respiratory tract infection, headache, and urinary tract infection[4].

Is ZORVOLEX covered by insurance?

Insurance companies are increasingly expanding coverage for non-opioid pain management therapies, including ZORVOLEX, recognizing their long-term benefits and cost savings compared to opioids[2].

Sources

1. Clinical trials on Zorvolex. Clinical trials arena.
2. Non-opioid Pain Treatment Market | Industry Report, 2030. Grand View Research.
3. Zorvolex (Diclofenac Capsules): Side Effects, Uses, Dosage. RxList.
4. Iroko Pharmaceuticals Release: New Long-Term Safety And Quality Of Life Data Reported For ZORVOLEX® In Osteoarthritis Patients. BioSpace.