CLINICAL TRIALS PROFILE FOR NAPROXEN

505(b)(2) Clinical Trials for NAPROXEN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01383486 ↗	Self Selection Trial of Naproxen Sodium	Completed	Bayer	Phase 3	2011-07-01	A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
OTC	NCT01365052 ↗	Safety Trial of Naproxen Sodium/ Diphenhydramine	Completed	Bayer	Phase 3	2011-05-01	The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
New Formulation	NCT00945178 ↗	Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers	Terminated	AstraZeneca	Phase 1	2009-08-01	The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.
OTC	NCT00751400 ↗	Naproxen Sodium Extended-Release Actual Use Study	Completed	Pegus Research, Inc.	Phase 3	2008-07-01	The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
OTC	NCT00751400 ↗	Naproxen Sodium Extended-Release Actual Use Study	Completed	Bayer	Phase 3	2008-07-01	The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
OTC	NCT00410995 ↗	Effects of Naproxen on Physical Performance	Terminated	University of Oklahoma	Phase 4	2004-05-01	The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.

All Clinical Trials for NAPROXEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00007189 ↗	Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)	Completed	Johns Hopkins University	Phase 3	2001-01-01	The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
NCT00007189 ↗	Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)	Completed	National Institute on Aging (NIA)	Phase 3	2001-01-01	The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
NCT00007189 ↗	Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)	Completed	University of Washington	Phase 3	2001-01-01	The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
NCT00001955 ↗	Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions)	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	1999-12-01	This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis. Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain. Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth. Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint. All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.
NCT00004845 ↗	A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)	Completed	Alzheimer's Disease Cooperative Study (ADCS)	Phase 2/Phase 3	1969-12-31	The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00004845 ↗	A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)	Completed	National Institute on Aging (NIA)	Phase 2/Phase 3	1969-12-31	The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.

Clinical Trial Conditions for NAPROXEN

Condition Name

Condition Name for NAPROXEN
Intervention	Trials
Osteoarthritis	29
Pain	28
Healthy	22
Migraine Disorders	18

Condition MeSH

Condition MeSH for NAPROXEN
Intervention	Trials
Osteoarthritis	52
Migraine Disorders	37
Osteoarthritis, Knee	33
Pain, Postoperative	20

Clinical Trial Locations for NAPROXEN

Trials by Country

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Trials by Country for NAPROXEN
Location	Trials
Canada	52
United Kingdom	34
Brazil	24
Poland	17
Mexico	15

Trials by US State

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−

Trials by US State for NAPROXEN
Location	Trials
Texas	78
Florida	60
California	60
New York	56
Illinois	50

Clinical Trial Progress for NAPROXEN

Clinical Trial Phase

Clinical Trial Phase for NAPROXEN
Clinical Trial Phase	Trials
Phase 4	83
Phase 3	72
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for NAPROXEN
Clinical Trial Phase	Trials
Completed	243
Not yet recruiting	17
Terminated	17

Clinical Trial Sponsors for NAPROXEN

Sponsor Name

Sponsor Name for NAPROXEN
Sponsor	Trials
GlaxoSmithKline	27
Bayer	26
Pfizer	25

Sponsor Type

Sponsor Type for NAPROXEN
Sponsor	Trials
Industry	213
Other	197
NIH	26

Naproxen: Clinical Trials, Market Analysis, and Projections

Introduction to Naproxen

Naproxen, a non-steroidal anti-inflammatory drug (NSAID), is widely used for treating various pain-related conditions, including arthritis, muscle strain, and menstrual cramps. Here, we will delve into the clinical trials, market analysis, and projections for this versatile medication.

Clinical Trials and Efficacy

Long-Term Treatment of Rheumatoid Arthritis

Clinical studies have demonstrated that naproxen is an effective and well-tolerated drug in the long-term treatment of rheumatoid arthritis. A study involving 42 patients across three controlled clinical trials showed that naproxen was at least as effective as aspirin, with fewer side effects. The trials included a double-blind comparison of aspirin and naproxen, long-term safety and efficacy monitoring, and a short period of double-blind placebo administration to test continued efficacy[1].

Comparative Studies

In these trials, naproxen was found to be superior in terms of both efficacy and tolerability. For instance, the incidence and severity of side effects were less with naproxen compared to aspirin. This makes naproxen a preferred option for patients requiring long-term management of rheumatoid arthritis[1].

Safety Profile

Naproxen has a relatively favorable safety profile. However, like other NSAIDs, it can lead to gastrointestinal adverse events such as GI bleeding, anorexia, and peptic ulcers, although these are reported in less than 1% to 10% of patients. Visual impairment, hypertension, and cardiovascular risks are also potential concerns, though they are generally observed in a small percentage of patients[4].

Market Analysis

Global Market Size and Growth

The global naproxen market is part of the larger NSAIDs market, which was valued at USD 19,551.54 million in 2021. It is expected to grow to USD 31.45 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 5.42% from 2022 to 2030. The naproxen market itself is anticipated to witness significant growth, driven by increasing demand for pain management and anti-inflammatory treatments[5].

Market Segmentation

The naproxen market is segmented based on several criteria, including region, distribution channels, and type of formulation. Key regions contributing to the market include North America, Europe, and the Asia Pacific. Retail pharmacies hold the largest market share, accounting for 46.41% in 2021, due to the increasing number of NSAIDs prescriptions and the rising availability of NSAIDs as over-the-counter drugs[5].

Key Players

The global naproxen market is dominated by several key players, including Teva and Kirsch Pharma GmbH. These companies play a significant role in defining the market competition landscape, SWOT analysis, and development plans for the next few years[2].

Market Projections

Growth Potential

The naproxen market is expected to grow substantially over the forecast period from 2024 to 2031. This growth is driven by factors such as increasing prevalence of chronic pain conditions, aging populations, and the expanding availability of naproxen in various formulations, including non-prescription forms like Aleve[3].

Regional Market Trends

In China, the market size of naproxen is valued at a significant amount and is expected to increase further by 2025, with a notable CAGR. Similar trends are observed in other regions, indicating a global demand for naproxen that is likely to continue growing[2].

Distribution Channels and Pricing

Retail pharmacies remain the primary distribution channel for naproxen, followed by hospitals and online pharmacies. The price trend for naproxen is expected to oscillate due to uncertainties in market demands and the global economy. However, the overall market is poised for continued growth despite these fluctuations[5].

Regulatory Approvals and New Formulations

FDA Approvals

Naproxen was approved by the FDA in 1976, and in January 1994, the FDA granted permission to market naproxen in a non-prescription form. Recently, in 2022, the USFDA approved Naproxen Sodium Softgel Capsules by Strides Pharma, which are used to treat pain or inflammation caused by various conditions, including arthritis and menstrual cramps[3].

New Formulations

The introduction of new formulations, such as naproxen sodium softgel capsules, is expected to enhance market growth. These formulations offer fast-onset pain relief and are preferred when immediate pain management is necessary[4].

Key Takeaways

• Clinical Efficacy: Naproxen is effective and well-tolerated in the long-term treatment of rheumatoid arthritis.
• Market Growth: The global naproxen market is expected to grow significantly, driven by increasing demand for pain management and anti-inflammatory treatments.
• Key Players: Companies like Teva and Kirsch Pharma GmbH dominate the market.
• Distribution Channels: Retail pharmacies hold the largest market share.
• Regulatory Approvals: Recent FDA approvals for new formulations are expected to boost market growth.

FAQs

What is naproxen used for?

Naproxen is used to treat various pain-related conditions, including arthritis, muscle strain, menstrual cramps, and acute pain from other disorders.

Is naproxen safe for long-term use?

Naproxen has been shown to be effective and well-tolerated in long-term clinical trials, but it can have side effects such as gastrointestinal issues and cardiovascular risks.

What are the common side effects of naproxen?

Common side effects include gastrointestinal adverse events, hypertension, and visual impairment, although these are generally observed in a small percentage of patients.

Who are the key players in the naproxen market?

Key players include Teva and Kirsch Pharma GmbH, among others.

What is the projected growth of the naproxen market?

The global naproxen market is expected to grow significantly, with a CAGR of 5.42% from 2022 to 2030, reaching USD 31.45 billion by 2030.

Sources

1. Clinical Experience With Naproxen in Rheumatoid Arthritis - JAMA Network.
2. Global Naproxen Market to Witness a Pronounce Growth During 2025 - OpenPR.
3. Global Anti-Inflammatory Drugs Market Size to Reach USD 250.08 Billion in 2030 - GlobeNewswire.
4. Naproxen - Elsevier Healthcare Hub.
5. Market Analysis and Price Projections for GNP Naproxen Sodium - Drug Patent Watch.