CLINICAL TRIALS PROFILE FOR PENNSAID

All Clinical Trials for Pennsaid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01119898 ↗	Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis	Completed	Mallinckrodt	Phase 2	2010-08-02	Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life. OA can occur in any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.
NCT01202799 ↗	Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel	Completed	Mallinckrodt	Phase 1	2010-09-01	It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject convenience and compliance with a comparable bioavailability, safety and tolerability profile to that of the approved PENNSAID solution administered four times a day (QID).
NCT01350622 ↗	Efficacy of PENNSAID® for Pain Management in the Emergency Department	Withdrawn	Medtronic - MITG	N/A	2011-12-01	The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.
NCT01350622 ↗	Efficacy of PENNSAID® for Pain Management in the Emergency Department	Withdrawn	University of Utah	N/A	2011-12-01	The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.
NCT01350622 ↗	Efficacy of PENNSAID® for Pain Management in the Emergency Department	Withdrawn	Virgil Davis	N/A	2011-12-01	The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.
NCT01508676 ↗	Effects of Pennsaid on Clinical Neuropathic Pain	Completed	Massachusetts General Hospital	N/A	2011-11-01	The purpose of this study is to see if the drug Pennsaid (Diclofenac) can help reduce pain felt by people with chronic nerve pain. The drug will be used 2-4 times each day for 2 weeks. The U.S. Food and Drug Administration (FDA) has approved Pennsaid to treat osteoarthritis (bone pain), but the FDA has not approved Pennsaid to treat neuropathic (nerve) pain. The research study will compare Pennsaid to placebo.
NCT01511939 ↗	Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants	Completed	Arthritis Treatment Center, Maryland	Phase 3	2012-02-01	The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic medications.

Clinical Trial Conditions for Pennsaid

Condition Name

Condition Name for Pennsaid
Intervention	Trials
Osteoarthritis of the Knee	2
Pain	2
Postherpetic Neuralgia	1
Reflex Sympathetic Dystrophy	1

Condition MeSH

Condition MeSH for Pennsaid
Intervention	Trials
Osteoarthritis	3
Osteoarthritis, Knee	2
Emergencies	1
Hemostatic Disorders	1

Clinical Trial Locations for Pennsaid

Trials by Country

Trials by Country for Pennsaid
Location	Trials
United States	17

Trials by US State

Trials by US State for Pennsaid
Location	Trials
Florida	2
Maryland	1
Massachusetts	1
Utah	1
Virginia	1

Clinical Trial Progress for Pennsaid

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Pennsaid
Clinical Trial Phase	Trials
Completed	4
Approved for marketing	1
Withdrawn	1

Clinical Trial Sponsors for Pennsaid

Sponsor Name

Sponsor Name for Pennsaid
Sponsor	Trials
Mallinckrodt	3
Medtronic - MITG	2
Arthritis Treatment Center, Maryland	1

Sponsor Type

Sponsor Type for Pennsaid
Sponsor	Trials
Industry	6
Other	5

PENNSAID (Diclofenac Sodium): Clinical Trials, Market Analysis, and Projections

Introduction

PENNSAID, a topical solution of diclofenac sodium, is a nonsteroidal anti-inflammatory drug (NSAID) specifically designed for the treatment of symptoms associated with osteoarthritis of the knee. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Clinical trials for PENNSAID have demonstrated its efficacy and safety in treating osteoarthritis symptoms. Here are some key findings:

• Efficacy: Studies have shown that PENNSAID is significantly more effective than the vehicle-control solution in reducing pain, improving physical function, and enhancing patient global assessment. The improvement in these efficacy variables ranged from 35% to 46% over baseline values[1].
• Safety: While PENNSAID was well-tolerated, minor skin irritations such as dryness, rash, and paresthesia were reported in some patients. However, there was no significant difference in NSAID-related gastrointestinal tract complaints or dropouts due to adverse effects between the treatment and control groups[1].
• Patient Outcomes: The trials involved a total of 326 patients randomized to receive either PENNSAID or the vehicle-control solution. The discontinuation rate due to lack of effect was higher in the control group (26% vs 17%), and the dropout rate due to adverse events was slightly higher in the PENNSAID group (5% vs 2%)[1].

Adverse Effects and Safety Considerations

• Skin Irritation: Common adverse effects include dryness, rash, and other minor skin irritations, which were reported in approximately 41.5% of patients receiving PENNSAID[1].
• Hematological Effects: PENNSAID does not significantly affect platelet aggregation, bleeding time, or other hematological parameters. However, monitoring is recommended for patients with coagulation disorders or those receiving anticoagulants[4].
• Liver and Renal Function: Mild elevations in liver enzyme tests (AST, ALT) can occur in some patients. It is crucial to monitor liver and renal function tests periodically, especially in patients on long-term treatment[3][4].

Market Analysis

Current Market Position

PENNSAID is part of the broader analgesics market, which is dominated by non-opioid analgesics such as NSAIDs and acetaminophen. The global analgesics market is driven by the increasing prevalence of chronic pain conditions and the growing demand for safer pain management solutions.

• Market Size: The global analgesics market was valued at $47.32 billion in 2023, with non-opioid analgesics accounting for approximately 65% of the market share[5].
• Regional Dominance: North America, particularly the United States, holds the largest share of the global analgesics market due to high incidence rates of chronic pain and a well-developed healthcare infrastructure[5].

Competitive Landscape

The market for analgesics is highly competitive, with several key players including Bausch Health Companies Inc., Amneal Pharmaceuticals LLC, and Apotex Inc. PENNSAID, as a topical NSAID, occupies a niche position within this market, offering a targeted treatment for osteoarthritis symptoms.

Market Projections

Growth Drivers

The growth of the analgesics market, including PENNSAID, is driven by several factors:

• Increasing Chronic Pain Prevalence: The rising incidence of chronic pain conditions such as arthritis and back pain is a significant driver[5].
• Shift to Non-Opioid Solutions: Growing awareness of the risks associated with opioid medications has led to an increased demand for non-opioid pain relief options, including topical NSAIDs like PENNSAID[5].
• OTC Accessibility: The ease of access to over-the-counter pain relief products, including some NSAIDs, contributes to market growth[5].

Future Outlook

The global analgesics market is projected to reach $75.73 billion by 2032, growing at a CAGR of 5.39% from 2024 to 2032. This growth is expected to be fueled by the increasing demand for effective and safer pain management solutions.

• Regional Growth: North America is expected to maintain its dominance, while the Asia-Pacific region is anticipated to experience rapid growth due to urbanization and an aging population[5].

Key Takeaways

• Clinical Efficacy: PENNSAID has demonstrated significant efficacy in reducing pain and improving physical function in patients with osteoarthritis of the knee.
• Safety Profile: While generally well-tolerated, PENNSAID can cause minor skin irritations and requires monitoring for hematological and liver function changes.
• Market Position: PENNSAID is part of the growing analgesics market, driven by the demand for non-opioid pain relief solutions.
• Future Projections: The analgesics market, including PENNSAID, is expected to grow significantly, driven by increasing chronic pain prevalence and a shift towards safer pain management options.

FAQs

Q: What is PENNSAID used for?

A: PENNSAID is used for the treatment of symptoms associated with osteoarthritis of the knee.

Q: What are the common adverse effects of PENNSAID?

A: Common adverse effects include minor skin irritations such as dryness and rash.

Q: How does PENNSAID compare to other pain relief medications?

A: PENNSAID is a topical NSAID, offering targeted relief for osteoarthritis symptoms without the systemic side effects associated with oral NSAIDs.

Q: What is the projected growth of the analgesics market?

A: The global analgesics market is projected to reach $75.73 billion by 2032, growing at a CAGR of 5.39% from 2024 to 2032.

Q: Why is there a shift towards non-opioid analgesics like PENNSAID?

A: The shift is driven by growing awareness of the risks and side effects associated with opioid medications, leading to an increased demand for safer pain management solutions.

Sources

1. JAMA Internal Medicine: Efficacy and Safety of a Topical Diclofenac Solution (Pennsaid) in Patients With Osteoarthritis of the Knee.
2. GlobalData: Net Present Value Model: Pennsaid.
3. Health Canada: PENNSAID® (diclofenac sodium) solution.
4. FDA: PENNSAID (diclofenac sodium) solution.
5. GlobeNewswire: Global Analgesics Market to Hit USD 75.73 Billion by 2032 Amid Rising Chronic Pain Cases and Surge in Non-Opioid Solutions.