CLINICAL TRIALS PROFILE FOR FAMOTIDINE AND IBUPROFEN

All Clinical Trials for Famotidine And Ibuprofen

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00450216 ↗	Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-03-01	The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00450658 ↗	Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-03-01	The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
NCT00613106 ↗	Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2007-09-01	The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
NCT00984815 ↗	Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 3	2009-09-01	The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
NCT01563185 ↗	Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis	Completed	Pediatric Rheumatology Collaborative Study Group	Phase 4	2012-04-01	The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
NCT01563185 ↗	Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis	Completed	Horizon Pharma Ireland, Ltd., Dublin Ireland	Phase 4	2012-04-01	The primary objective of this Phase 4, multi-center, open-label study is to evaluate the safety and tolerability of DUEXIS in Juvenile Idiopathic Arthritis (JIA) patients aged 10 years to 16 years, 11 months, treated up to 24 weeks. The secondary objectives are to evaluate the PK characteristics of DUEXIS in JIA patients and to evaluate the signs and symptoms of JIA in patients aged 10 years to 16 years, 11 months receiving DUEXIS for up to 24 weeks.
NCT03695172 ↗	Comparison of TAP, Anterior QL, or ESP Block for Elective Cesarean Section	Terminated	Duke University	Phase 4	2019-09-12	The purpose of this prospective single center, randomized study is to determine if ultrasound guided Transversus Abdominis Plane (TAP), Quadratus Lumborum (QL), and Erector Spinae Plane (ESP) blocks decrease opioid consumption in subjects undergoing elective cesarean section.

Clinical Trial Conditions for Famotidine And Ibuprofen

Condition Name

Condition Name for Famotidine And Ibuprofen
Intervention	Trials
Chronic Low Back Pain	2
Chronic Regional Pain Syndrome	2
Chronic Soft Tissue Pain	2
Osteoarthritis	2

Condition MeSH

Condition MeSH for Famotidine And Ibuprofen
Intervention	Trials
Osteoarthritis	2
Nociceptive Pain	2
Low Back Pain	2
Back Pain	2

Clinical Trial Locations for Famotidine And Ibuprofen

Trials by Country

Trials by Country for Famotidine And Ibuprofen
Location	Trials
United States	9

Trials by US State

Trials by US State for Famotidine And Ibuprofen
Location	Trials
Texas	2
Pennsylvania	2
North Carolina	1
Massachusetts	1
Louisiana	1

Clinical Trial Progress for Famotidine And Ibuprofen

Clinical Trial Phase

Clinical Trial Phase for Famotidine And Ibuprofen
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4

Clinical Trial Status

Clinical Trial Status for Famotidine And Ibuprofen
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for Famotidine And Ibuprofen

Sponsor Name

Sponsor Name for Famotidine And Ibuprofen
Sponsor	Trials
Horizon Pharma Ireland, Ltd., Dublin Ireland	5
Pediatric Rheumatology Collaborative Study Group	1
Duke University	1

Sponsor Type

Sponsor Type for Famotidine And Ibuprofen
Sponsor	Trials
Industry	5
Other	2

Famotidine and Ibuprofen: Clinical Trials, Market Analysis, and Projections

Introduction

Famotidine and ibuprofen, combined in the drug Duexis, represent a significant advancement in the treatment of rheumatoid arthritis and osteoarthritis. This combination therapy leverages the anti-inflammatory properties of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and the gastrointestinal protective effects of famotidine, a histamine H2-receptor antagonist.

Clinical Trials and Indications

FDA Approved Indications

Duexis is FDA-approved for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. It is also indicated to decrease the risk of developing upper gastrointestinal ulcers in patients taking ibuprofen for these conditions[1][3][4].

Clinical Trial Outcomes

The clinical trials primarily enrolled patients under 65 years of age without a prior history of gastrointestinal ulcers. These trials demonstrated the efficacy of Duexis in reducing the risk of gastric and duodenal ulcers, which are common adverse effects associated with NSAID use. The trials did not extend beyond six months, highlighting the need for ongoing monitoring and assessment of long-term safety and efficacy[1][3][4].

Contraindications and Precautions

Duexis is contraindicated in patients with known hypersensitivity to ibuprofen or famotidine, those with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, and in the setting of coronary artery bypass graft (CABG) surgery. Patients should be cautious about the risk of serious gastrointestinal adverse events, hepatotoxicity, and hypertension when using this medication[4].

Market Analysis

Current Market Size

The global ibuprofen market, which includes the combination therapy of ibuprofen and famotidine, was valued at $100 million in 2023. The market for ibuprofen-famotidine tablets specifically was approximately $49 million for the 12 months ended December 31, 2023[2][3].

Growth Drivers

The market is driven by several key factors:

• Rising Prevalence of Chronic Diseases: The increasing incidence of arthritis, cardiovascular conditions, and other chronic diseases is driving the demand for pain management solutions. Arthritis, in particular, affects a significant portion of the population, with 47.3% of adults diagnosed with the condition[2][5].
• Accessibility and Awareness: The high adoption of ibuprofen as an over-the-counter (OTC) pain relief medication and its reputation for quick and reliable pain relief contribute to market growth[2].
• Healthcare Infrastructure: Well-developed healthcare infrastructure, especially in regions like North America, supports the market expansion[2].

Market Projections

The global ibuprofen market is projected to reach $213.6 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.9% from 2024 to 2033. Another forecast suggests the market will reach $111.41 million by 2031, growing at a CAGR of 2.40% from 2024 to 2031, though this figure may be more conservative or based on different market segments[2][5].

Market Segmentation

By Application

The ibuprofen market, including the combination with famotidine, is segmented into various applications:

• Rheumatoid Arthritis and Osteoarthritis: This segment is expected to hold the largest revenue share due to the increasing demand for effective analgesic and anti-inflammatory treatments for these conditions[5].
• Cancer, Pain/Fever/Dysmenorrhea, Inflammatory Diseases, and Headache: These segments also contribute significantly to the market, reflecting the versatile use of ibuprofen in managing various types of pain and inflammation[5].

Key Market Players

The market for ibuprofen and its combinations, including Duexis, involves several key players:

• Abbott Laboratories
• Perrigo Company Plc
• Solara Active Pharma Sciences Ltd
• Biocause Inc
• Shandong Xinhua Pharmaceutical Co Ltd
• Pfizer Inc.
• Hubei Biocause Pharmaceutical Co Ltd
• Strides Pharma Science Ltd
• IOL Chemicals and Pharmaceutical Ltd
• BASF SE[2].

Adverse Events and Safety Considerations

The most common adverse reactions to ibuprofen and famotidine tablets include nausea, diarrhea, constipation, upper abdominal pain, and headache. Serious adverse events such as gastrointestinal bleeding, ulceration, and perforation can occur, especially in elderly patients and those with a prior history of peptic ulcer disease or GI bleeding[3][4].

Conclusion

The combination of famotidine and ibuprofen in Duexis offers a valuable treatment option for patients with rheumatoid arthritis and osteoarthritis by providing both pain relief and gastrointestinal protection. The market for this combination is driven by the increasing prevalence of chronic diseases and the high adoption of ibuprofen for pain management. As the market continues to grow, it is crucial for healthcare providers and patients to be aware of the potential benefits and risks associated with this medication.

Key Takeaways

• Clinical Trials: Duexis has been shown to be effective in reducing the risk of gastrointestinal ulcers in patients taking ibuprofen for rheumatoid arthritis and osteoarthritis.
• Market Growth: The global ibuprofen market, including the combination with famotidine, is projected to grow significantly due to the rising prevalence of chronic diseases and the high adoption of ibuprofen.
• Safety Considerations: Patients should be aware of the potential adverse events, including gastrointestinal bleeding and hepatotoxicity.
• Market Segmentation: The market is segmented by application, with rheumatoid arthritis and osteoarthritis being the largest revenue-generating segments.
• Key Players: Several pharmaceutical companies are involved in the production and distribution of ibuprofen and its combinations.

FAQs

What are the FDA-approved indications for Duexis?

Duexis is FDA-approved for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing upper gastrointestinal ulcers in patients taking ibuprofen for these conditions[1][3][4].

What are the common adverse reactions to ibuprofen and famotidine tablets?

The most common adverse reactions include nausea, diarrhea, constipation, upper abdominal pain, and headache[3].

What is the projected market size for the global ibuprofen market by 2033?

The global ibuprofen market is projected to reach $213.6 million by 2033, growing at a CAGR of 7.9% from 2024 to 2033[2].

Which segment is expected to hold the largest revenue share in the ibuprofen market?

The segment for rheumatoid arthritis and osteoarthritis is expected to hold the largest revenue share due to the increasing demand for effective analgesic and anti-inflammatory treatments for these conditions[5].

What are the contraindications for using Duexis?

Duexis is contraindicated in patients with known hypersensitivity to ibuprofen or famotidine, those with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs, and in the setting of coronary artery bypass graft (CABG) surgery[4].

Sources

1. Delaware First Health - CP.PMN.120 Ibuprofen/Famotidine (Duexis) Clinical Policy.
2. Allied Market Research - Ibuprofen Market Statistics, Growth Drivers | Forecast - 2033.
3. PR Newswire - Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of Duexis.
4. FDA - DUEXIS (ibuprofen and famotidine) Label.
5. Verified Market Research - Ibuprofen Market Size, Share, Scope, Trends, Growth & Forecast.