CLINICAL TRIALS PROFILE FOR NAROPIN

All Clinical Trials for Naropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00562627 ↗	Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty	Completed	Asker & Baerum Hospital	Phase 4	2007-11-01	Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge. The aim of this study is to: 1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty. 2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.
NCT00573963 ↗	Efficacy of the Transversus Abdominus Plane (TAP) Block for Post-Cesarean Delivery Analgesia	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2007-12-01	The purpose of this study is to determine if patients having the transversus abdominal place (TAP) block at the end of a cesarean delivery have less pain in the post-delivery period than those who do not. Freezing medication is injected between the layers of muscle on either side of the belly, to freeze the nerves that carry pain stimuli from an abdominal wound. This technique has been useful for many abdominal operations, and has recently been studied in cesarean sections, however more information is needed.
NCT00603083 ↗	Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia	Completed	Vejle Hospital	Phase 4	2008-01-01	The purpose of this study is to determine whether the investigator standardized pain treatment plus local pain treatment is more effective than the investigator standardized pain treatment plus placebo in total hip arthroplasty.
NCT00702416 ↗	Ultrasound Guidance for Interscalene Brachial Plexus Block	Completed	University of Parma	Phase 4	2008-05-01	This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery. The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation. The aim of this study is to define which technique is better in terms of time to onset of anesthesia.
NCT00724035 ↗	Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery	Completed	University of Parma	Phase 4	2008-05-01	This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques. Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery. The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.
NCT00868348 ↗	A Comparison of Naropin and Ketorolac for Postoperative Analgesia After Total Knee Arthroplasty	Completed	University of Aarhus	Phase 4	2009-05-01	The purpose of this study is to determine wether ketorolac is effective in the treatment of postoperative pain after total knee arthroplasty
NCT00987441 ↗	Epidural Labor Analgesia and Infant Neurobehavior	Completed	Nanjing Medical University	N/A	2009-09-01	Infant neurobehavior alteration is predictor of later intelligence development. Many factors would influence or are associated with infant neurobehavior, of which exist or appear during perinatal period. Neuraxial, especially epidural, analgesia to date is the most effective method in relieving labor pain. Although previous studies showed that opioid used in epidural analgesia for labor pain can affect newborn neurobehavior negatively in a dose-escalation associated manner, whether epidural analgesia itself would produce unpredictable effect on newborn neurobehavior is still unknown. Hereby the investigators designed this trial to investigate the hypothesis that epidural analgesia for labor pain control itself would not produce negative effect on infant neurobehavior.

Clinical Trial Conditions for Naropin

Condition Name

Condition Name for Naropin
Intervention	Trials
Pain, Postoperative	24
Postoperative Pain	16
Pain	16
Shoulder Pain	5

Condition MeSH

Condition MeSH for Naropin
Intervention	Trials
Pain, Postoperative	47
Osteoarthritis	12
Fractures, Bone	9
Osteoarthritis, Knee	7

Clinical Trial Locations for Naropin

Trials by Country

Trials by Country for Naropin
Location	Trials
United States	77
Denmark	14
Canada	14
China	9
Singapore	4

Trials by US State

Trials by US State for Naropin
Location	Trials
Ohio	7
Florida	6
North Carolina	5
Massachusetts	5
New York	5

Clinical Trial Progress for Naropin

Clinical Trial Phase

Clinical Trial Phase for Naropin
Clinical Trial Phase	Trials
Phase 4	71
Phase 3	20
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Naropin
Clinical Trial Phase	Trials
Completed	93
Recruiting	19
Withdrawn	15

Clinical Trial Sponsors for Naropin

Sponsor Name

Sponsor Name for Naropin
Sponsor	Trials
Boston Children's Hospital	6
Boston Children’s Hospital	5
Duke University	5

Sponsor Type

Sponsor Type for Naropin
Sponsor	Trials
Other	215
Industry	12
U.S. Fed	5

Naropin (Ropivacaine): Clinical Trials, Market Analysis, and Projections

Introduction to Naropin (Ropivacaine)

Naropin, also known as ropivacaine, is a local and regional anesthetic widely used in surgical procedures and for short-term pain management, including postoperative and labor pain. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Recent Clinical Trials

Cali Biosciences' CPL-01 Study

Cali Biosciences has been conducting significant research on an extended-release version of ropivacaine, known as CPL-01. This Phase 2b clinical trial, part of the MERIT studies (Management of post-op pain and Evaluation of Reduction In Therapeutic opioids), aims to evaluate the efficacy and safety of CPL-01 in treating post-operative pain and reducing opioid use.

• Key Findings: The trial demonstrated an excellent dose-response for efficacy, with subjects receiving CPL-01 showing a significant reduction in pain and opioid use compared to those receiving placebo or the standard Naropin®. Specifically, opioid use was cut in half, and approximately two-thirds of the CPL-01 subjects required no opioids after the first 72 hours post-operation[1][5].

PainReform's PRF-110 Study

PainReform has also been conducting a Phase 3 clinical trial for PRF-110, an oil-based, extended-release formulation of ropivacaine. This study focuses on post-surgical pain management in bunionectomy patients.

• Initial Results: The initial analysis showed statistically significant pain reduction over placebo during the first 48 hours post-surgery. However, data incoherence for the subsequent 24-hour period has raised concerns about the complete efficacy profile and potential regulatory impacts[4].

Market Analysis

Current Market Trends

The ropivacaine market has been influenced by several factors, including the COVID-19 pandemic and demographic changes.

• Pandemic Impact: The pandemic led to a significant decline in surgical procedures, resulting in decreased demand for ropivacaine. This disruption in surgical activities and supply chain issues further exacerbated the decline in sales[2].

• Demographic Factors: The increasing geriatric population, particularly in regions like North America and Asia Pacific, is driving the demand for surgeries and subsequently for anesthetics like ropivacaine. This demographic shift is expected to continue supporting market growth[2].

Regional Market Share

• North America: This region holds the largest share of the ropivacaine market due to the high number of surgeries, including cesarean sections, and favorable reimbursement policies. These factors contribute to the increased adoption of ropivacaine among patients[2].

• Asia Pacific: This region is anticipated to register a considerable growth rate due to the growing geriatric population, increased awareness about the advantages of ropivacaine, and rising healthcare expenditure[2].

Market Projections

Future Growth

Despite the challenges posed by the pandemic, the ropivacaine market is expected to grow in the coming years.

• Increasing Surgical Procedures: The rise in major surgeries such as cardiovascular and general surgeries will drive the demand for anesthetic injections like ropivacaine[2].

• Regulatory Approvals: Key players are focusing on receiving regulatory approvals for introducing new anesthetic formulations, which will increase the availability and adoption of ropivacaine[2].

• Extended-Release Formulations: The development of extended-release formulations like CPL-01 and PRF-110 is expected to enhance the market by offering prolonged pain relief and reducing opioid dependency[1][4].

Competitive Landscape

The market for ropivacaine is competitive, with several key players involved.

• Major Players: Companies such as Pfizer Inc., AstraZeneca, Aspen Pharmacare, Akorn Operating Company LLC, and Nephron Pharmaceuticals Corporation are prominent in the market. These companies are continuously working on improving their products and obtaining regulatory approvals to expand their market share[2].

Safety and Efficacy

Pharmacokinetics and Safety

The safety profile of ropivacaine, especially in its extended-release forms, has been a focus of recent studies.

• CPL-01 Safety: The pharmacokinetics of CPL-01 have supported its safety, with a lower maximum concentration (Cmax) compared to Naropin®, reducing the risk of cardiac toxicity. The study also reported common post-surgical adverse events but none related to CPL-01[5].

• PRF-110 Safety: The initial part of the PRF-110 trial met all safety requirements, including plasma concentration levels, allowing the study to proceed to the next phase[4].

Expert Insights

Dr. Todd Bertoch, an anesthesiologist involved in the trials, highlighted the significance of the results from the CPL-01 study: "These results are incredibly exciting, and say to me that, with successful completion of this Phase II study, Cali Biosciences is leading the way to produce the first long-acting ropivacaine for patients."[5]

Key Takeaways

• Clinical Trials: Recent trials by Cali Biosciences and PainReform show promising results for extended-release ropivacaine formulations in reducing post-operative pain and opioid use.
• Market Trends: The market is recovering from pandemic-related declines, driven by increasing surgical procedures and a growing geriatric population.
• Regional Growth: North America and Asia Pacific are key regions for market growth due to high surgical rates and favorable healthcare policies.
• Safety and Efficacy: Extended-release formulations have demonstrated a favorable safety profile and significant pain reduction.

FAQs

What is the current status of Cali Biosciences' CPL-01 clinical trial?

Cali Biosciences has announced successful results in its Phase IIb study of CPL-01, showing significant pain reduction and reduced opioid use compared to placebo and standard Naropin®[1][5].

How has the COVID-19 pandemic affected the ropivacaine market?

The pandemic led to a decline in surgical procedures, resulting in decreased demand and sales of ropivacaine. Supply chain disruptions further exacerbated this decline[2].

What are the key regions driving the growth of the ropivacaine market?

North America and Asia Pacific are the primary regions driving market growth due to high surgical rates and favorable healthcare policies[2].

What are the benefits of extended-release ropivacaine formulations?

Extended-release formulations like CPL-01 and PRF-110 offer prolonged pain relief and reduce the need for opioids, enhancing patient care and safety[1][4].

Who are the major players in the ropivacaine market?

Key players include Pfizer Inc., AstraZeneca, Aspen Pharmacare, Akorn Operating Company LLC, and Nephron Pharmaceuticals Corporation[2].

Sources

1. CenExel Research: "Cali Biosciences Initiates Phase 2b Study of Long-Acting Ropivacaine for Non-Opioid Treatment of Post-Operative Pain"[1].
2. Fortune Business Insights: "Ropivacaine Market Size, Industry Share | Forecast, 2032"[2].
3. IndustryARC: "Local Anesthesia Drugs Market Share, Size and Industry Growth"[3].
4. StockTitan: "PainReform Announces Initial Topline Data for PRF-110 Phase 3 Clinical Trial"[4].
5. BioSpace: "Cali Biosciences Announces Successful Results in Phase IIb Study of Long-Acting Ropivacaine (CPL-01) for Non-Opioid Treatment of Post-Operative Pain"[5].