CLINICAL TRIALS PROFILE FOR IBUPROFEN LYSINE

All Clinical Trials for IBUPROFEN LYSINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03180879 ↗	Ibuprofen Bioavailability Study	Completed	Simbec Research	Phase 1	2017-04-10	This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
NCT03180879 ↗	Ibuprofen Bioavailability Study	Completed	Reckitt Benckiser Healthcare (UK) Limited	Phase 1	2017-04-10	This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.
NCT02974361 ↗	Impact of Excipients on Pharmacokinetics of OXPzero(TM) Ibuprofen	Completed	Oxford Pharmascience Ltd	Phase 1	2016-12-01	This study is to help development of a new version of Ibuprofen, called Ibuprofen-LDH. Ibuprofen-LDH will be used as a treatment for muscular pains, headache, fever etc. This new version of ibuprofen is expected to produce fewer stomach/intestine related side effects when compared to many existing marketed formulations of Ibuprofen. This study is split into 3 parts. Part A is a 7 way crossover, Part B is a maximum of a 6 way crossover and Part C is a maximum of a 4 way crossover. The size of Parts B & Part C and allocated interventions will be confirmed after review of data from Parts A and/or B respectively. A total of 30 subjects will take part in the study; 10 per study part. The key objective is to assess the pharmacokinetics properties of Ibuprofen-LDH, with and without a selection of different excipients. The pharmacokinetic properties will include how quickly the drug is absorbed into the bloodstream and also the maximum concentration of drug that reaches the bloodstream.
NCT02452450 ↗	Ibuprofen and Paracetamol Pharmacokinetic Study	Completed	Simbec Research	Phase 1	2014-01-01	The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.
NCT02452450 ↗	Ibuprofen and Paracetamol Pharmacokinetic Study	Completed	Reckitt Benckiser Healthcare (UK) Limited	Phase 1	2014-01-01	The purpose of this study was to determine rates of absorption of Ibuprofen and Paracetamol formulations.
NCT00440804 ↗	Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA	Completed	Farmacon	Phase 3	2002-12-01	The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.

Clinical Trial Conditions for IBUPROFEN LYSINE

Condition Name

Condition Name for IBUPROFEN LYSINE
Intervention	Trials
Healthy	1
Healthy Subjects	1
Healthy Volunteer Study	1
Patent Ductus Arteriosus	1

Condition MeSH

Condition MeSH for IBUPROFEN LYSINE
Intervention	Trials
Ductus Arteriosus, Patent	1

Clinical Trial Locations for IBUPROFEN LYSINE

Trials by Country

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−

Trials by Country for IBUPROFEN LYSINE
Location	Trials
United Kingdom	2

Clinical Trial Progress for IBUPROFEN LYSINE

Clinical Trial Phase

Clinical Trial Phase for IBUPROFEN LYSINE
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	4

Clinical Trial Status

Clinical Trial Status for IBUPROFEN LYSINE
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for IBUPROFEN LYSINE

Sponsor Name

Sponsor Name for IBUPROFEN LYSINE
Sponsor	Trials
Reckitt Benckiser Healthcare (UK) Limited	3
Simbec Research	2
Farmacon	1

Sponsor Type

Sponsor Type for IBUPROFEN LYSINE
Sponsor	Trials
Industry	7

Ibuprofen Lysine: Clinical Trials, Market Analysis, and Projections

Introduction

Ibuprofen lysine, a soluble form of the non-steroidal anti-inflammatory drug (NSAID) ibuprofen, has been gaining attention for its potential in various medical applications. This article will delve into the recent clinical trials, market analysis, and projections for ibuprofen lysine.

Clinical Trials: Efficacy and Safety

Acute Pain Management

A recent clinical study compared the efficacy of ibuprofen lysine with ibuprofen in managing acute pain. The study involved 351 patients, with 141 receiving ibuprofen lysine, 139 receiving ibuprofen, and 71 receiving a placebo. The results showed that both ibuprofen lysine and ibuprofen significantly reduced pain compared to the placebo, with no significant difference in efficacy between the two drugs. However, ibuprofen lysine did not demonstrate a faster onset of action compared to ibuprofen[1].

Treatment of Patent Ductus Arteriosus (PDA)

Ibuprofen lysine injection is used to treat PDA in preterm infants. Clinical trials have shown that ibuprofen lysine is effective in closing the ductus arteriosus, with a lower need for rescue therapy compared to placebo. However, the treatment did not significantly impact other outcomes such as the need for ventilator support, oxygenation, or the incidence of complications like necrotizing enterocolitis and intraventricular hemorrhage[3].

First-Trimester Abortion-Related Pain

A randomized triple-blinded clinical trial investigated the efficacy of ibuprofen lysine in reducing pain and hemorrhage during first-trimester medical abortions. The study found that ibuprofen lysine significantly reduced pain intensity and bleeding rates compared to the placebo group, making it a viable pharmacological option for managing abortion-related pain and hemorrhage[5].

Market Analysis

Market Size and Forecast

The global ibuprofen lysine market is expected to experience significant growth, with a projected Compound Annual Growth Rate (CAGR) of 3 to 5% from 2023 to 2031. The market size is anticipated to increase substantially, driven by increasing demand in hospitals, drug stores, and other healthcare settings. The market is segmented by application (hospital, drug store, other), product type (vial, pre-filled), and geographical regions (North America, Europe, Asia-Pacific, etc.)[2][4].

Market Dynamics

The market dynamics are influenced by several factors, including drivers such as the growing need for effective pain management and the treatment of PDA in preterm infants. However, restraints such as potential side effects and contraindications in certain patient groups also play a role. The market is further shaped by opportunities like the expansion into new geographical regions and the development of new formulations[2][4].

Key Players

Major players in the ibuprofen lysine market include companies like Lundbeck, which have been instrumental in the development and distribution of ibuprofen lysine products. These companies are profiled in market reports, providing insights into their market entry strategies, product offerings, and competitive landscape[2][4].

Market Projections

Geographical Expansion

The ibuprofen lysine market is expected to grow across various geographical regions, with significant potential in countries like the United States, Canada, Germany, the UK, and several Asian countries. The report highlights the market development in these regions, providing a detailed analysis of the market dynamics and growth prospects[2][4].

Product Segmentation

The market is segmented into different product types, including vials and pre-filled formulations. These segments are expected to grow as healthcare providers seek more convenient and efficient ways to administer the drug. The report provides a thorough overview of the market size and forecast for each product segment[2][4].

Application Segmentation

Ibuprofen lysine is used in various healthcare settings, including hospitals and drug stores. The market analysis indicates that these segments will continue to drive the growth of the ibuprofen lysine market, with hospitals being a major contributor due to the drug's use in treating PDA and other conditions[2][4].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the ibuprofen lysine market. While the pandemic disrupted supply chains and healthcare services, it also highlighted the need for effective pain management and treatment options for various conditions. Market reports provide strategies for companies to deal with the impact of COVID-19, including market entry strategies and adjustments to distribution models[4].

Key Takeaways

• Clinical Efficacy: Ibuprofen lysine has been shown to be effective in managing acute pain, treating PDA in preterm infants, and reducing pain and hemorrhage during first-trimester medical abortions.
• Market Growth: The global ibuprofen lysine market is projected to grow at a CAGR of 3 to 5% from 2023 to 2031, driven by increasing demand in various healthcare settings.
• Market Segmentation: The market is segmented by application, product type, and geographical regions, with significant growth potential in hospitals and drug stores.
• Key Players: Companies like Lundbeck are key players in the market, with strategies focused on market expansion and product development.
• COVID-19 Impact: The pandemic has necessitated strategic adjustments by companies to maintain market growth and address new challenges.

FAQs

What is ibuprofen lysine used for?

Ibuprofen lysine is used for managing acute pain, treating patent ductus arteriosus (PDA) in preterm infants, and reducing pain and hemorrhage during first-trimester medical abortions.

How does ibuprofen lysine compare to ibuprofen in terms of efficacy?

Ibuprofen lysine is comparably effective to ibuprofen in managing acute pain but does not have a faster onset of action.

What are the potential side effects of ibuprofen lysine?

Potential side effects include inhibition of platelet aggregation, bilirubin displacement, and renal function impairment. It can also alter the usual signs of infection and should be used with caution in preterm infants with certain conditions[1][3].

Which companies are major players in the ibuprofen lysine market?

Major players include companies like Lundbeck, which are involved in the development, distribution, and marketing of ibuprofen lysine products[2][4].

How has the COVID-19 pandemic affected the ibuprofen lysine market?

The pandemic has disrupted supply chains but also highlighted the need for effective pain management and treatment options, necessitating strategic adjustments by companies to maintain market growth[4].

Sources

1. Treatment of acute pain: comparison of the efficacy of ibuprofen lysinate and ibuprofen. European Federation for Separation Science.
2. Global Ibuprofen Lysine Market Size And Forecast. Market Research Intellect.
3. Ibuprofen Lysine Injection. FDA.
4. Global Ibuprofen Lysine Market Development Strategy Pre and Post COVID-19. Report Ocean.
5. Efficacy of Ibuprofen Lysine on First-Trimester Abortion-Related Pain. PubMed.