CLINICAL TRIALS PROFILE FOR REMIFENTANIL HYDROCHLORIDE

505(b)(2) Clinical Trials for remifentanil hydrochloride

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
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Baylor College of Medicine	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Boston Children's Hospital	Phase 3	2017-08-10	There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Formulation	NCT02307721 ↗	Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	St. Olavs Hospital	Phase 1/Phase 2	2014-12-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.
New Formulation	NCT02307721 ↗	Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use	Completed	Norwegian University of Science and Technology	Phase 1/Phase 2	2014-12-01	Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil.

All Clinical Trials for remifentanil hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209872 ↗	Optimal Multimodal Analgesia in Abdominal Hysterectomy	Unknown status	Hvidovre University Hospital	Phase 4	2005-10-01	The purpose of this study is to test the current standard of care (SOC) treatment for abdominal hysterectomy with a group receiving SOC minus epidural analgesia plus additional perioperative analgesics in terms of postoperative abilities, postoperative nausea and vomiting (PONV), pain and discharge time from the PACU (post-anaesthesia care unit).
NCT00162591 ↗	Bispectral Index as an Analgesia Monitoring in Severely Ill Patient: Effect of Remifentanyl	Unknown status	Assistance Publique - Hôpitaux de Paris	N/A	2004-10-01	The aim of this protocol is to study the prophylactic effect of remifentanil on bispectral index variation during a nociceptive stimuli.
NCT00158873 ↗	Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects	Completed	GlaxoSmithKline	Phase 4	2004-09-01	The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.
NCT00202722 ↗	Remifentanil as Intravenous Patient-controlled Analgesia (IVPCA) During Labour	Completed	Sorlandet Hospital HF	Phase 4	2004-01-01	Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

Clinical Trial Conditions for remifentanil hydrochloride

Condition Name

Condition Name for remifentanil hydrochloride
Intervention	Trials
Anesthesia	86
Pain	39
Postoperative Pain	38
Pain, Postoperative	28

Condition MeSH

Condition MeSH for remifentanil hydrochloride
Intervention	Trials
Pain, Postoperative	76
Hyperalgesia	22
Postoperative Nausea and Vomiting	17
Vomiting	15

Clinical Trial Locations for remifentanil hydrochloride

Trials by Country

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Trials by Country for remifentanil hydrochloride
Location	Trials
Korea, Republic of	125
China	104
United States	63
France	49
Turkey	41

Trials by US State

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−

Trials by US State for remifentanil hydrochloride
Location	Trials
Ohio	10
Illinois	8
New York	7
California	6
Texas	6

Clinical Trial Progress for remifentanil hydrochloride

Clinical Trial Phase

Clinical Trial Phase for remifentanil hydrochloride
Clinical Trial Phase	Trials
Phase 4	292
Phase 3	52
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for remifentanil hydrochloride
Clinical Trial Phase	Trials
Completed	408
Recruiting	97
Unknown status	86

Clinical Trial Sponsors for remifentanil hydrochloride

Sponsor Name

Sponsor Name for remifentanil hydrochloride
Sponsor	Trials
Yonsei University	35
Ajou University School of Medicine	23
Seoul National University Hospital	16

Sponsor Type

Sponsor Type for remifentanil hydrochloride
Sponsor	Trials
Other	910
Industry	48
U.S. Fed	5

Remifentanil Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Remifentanil hydrochloride is a potent, short-acting opioid analgesic widely used in anesthesia and pain management during surgical procedures. This article provides an update on clinical trials, market analysis, and projections for this drug.

Clinical Trials and Safety Profile

Current Trials and Studies

While specific details on ongoing clinical trials for remifentanil hydrochloride are not extensively available in the sources, it is known that clinical trials typically involve several phases, including screening, treatment, recovery, and follow-up phases. These trials are crucial for evaluating the safety and efficacy of the drug in various clinical settings[4].

Safety and Efficacy

Remifentanil hydrochloride has a well-documented safety profile, but it requires careful dosing and monitoring to mitigate risks such as respiratory depression, particularly during initiation and titration. It is contraindicated for epidural or intrathecal administration and in patients with hypersensitivity to remifentanil. The drug also poses risks when used with concomitant benzodiazepines or other CNS depressants, and in patients with increased intracranial pressure, brain tumors, head injury, or impaired consciousness[1].

Market Analysis

Market Size and Growth

The remifentanil hydrochloride market is anticipated to experience significant growth over the next decade. According to Introspective Market Research, the market size was valued at USD 280.09 million in 2023 and is projected to reach USD 337.7 million by 2032, growing at a CAGR of 2.10% from 2024-2032[5].

Market Segmentation

The market is segmented by product type, application, distribution channel, and region. The product type segment includes injections and pre-mixed solutions, with injections accounting for the highest market share due to their widespread use in hospitals and surgical centers for anesthesia and pain management. By application, the market is categorized into cardiac surgery, neurosurgery, general surgery, urology, and obstetrics & gynecology, with neurosurgery holding the largest share of 57.64% in 2023[5].

Regional Analysis

North America dominates the remifentanil hydrochloride market due to its robust healthcare infrastructure, advanced technological capabilities, and strong R&D prowess. The region is expected to continue leading the market, followed by the Asia-Pacific region, which is showing rapid growth due to improving healthcare and pain management awareness[5].

Market Drivers and Trends

Increasing Surgical Procedures

The rise in surgical procedures, including minimally invasive surgeries and outpatient procedures, is a key driver of the remifentanil hydrochloride market. This increase is fueled by a growing awareness of pain management solutions and advancements in anesthetic techniques[3].

Advancements in Drug Delivery

Innovation in drug delivery systems and formulation advancements are enhancing the market prospects for remifentanil hydrochloride. These innovations aim to improve stability, reduce medication errors, and optimize the drug's effectiveness[5].

Growing Geriatric Population

A growing geriatric population and a surge in chronic pain conditions are also contributing to the market expansion. This demographic shift increases the demand for effective pain management solutions during surgical procedures[3].

Competitive Landscape

Key Market Players

The remifentanil hydrochloride market is competitive, with several key players focusing on sustaining a competitive environment and increasing their market share. These players are involved in continuous safety and efficacy enhancements, as well as collaborations in drug delivery and formulation advancements[5].

Future Outlook

Innovation and Technology

The future outlook for remifentanil hydrochloride is promising, with ongoing innovations in drug delivery systems and the integration of remote monitoring technologies expected to enhance its clinical application. Collaborative efforts among healthcare providers and pharmaceutical stakeholders are anticipated to propel market dynamics significantly over the coming years[3].

Regulatory Scrutiny

The market is also witnessing enhanced regulatory scrutiny and approval processes, which focus on safety and efficacy. This scrutiny ensures that the drug meets stringent standards, further solidifying its position in the market[3].

Key Takeaways

• Market Growth: The remifentanil hydrochloride market is projected to grow at a CAGR of 2.10% from 2024-2032, reaching USD 337.7 million by 2032.
• Segmentation: The market is segmented by product type (injections and pre-mixed solutions), application (neurosurgery, cardiac surgery, etc.), and region (North America, Asia-Pacific, etc.).
• Drivers: Key drivers include increasing surgical procedures, advancements in anesthetic techniques, and growing awareness of pain management solutions.
• Safety Profile: The drug requires careful dosing and monitoring to mitigate risks such as respiratory depression.
• Innovation: Ongoing innovations in drug delivery systems and formulation advancements are expected to enhance the drug's effectiveness and market prospects.

FAQs

What are the primary uses of remifentanil hydrochloride?

Remifentanil hydrochloride is primarily used as an analgesic component of monitored anesthesia care in adult patients and for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner[1].

What are the common adverse reactions associated with remifentanil hydrochloride?

The most common adverse reactions include respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity[1].

Which region dominates the remifentanil hydrochloride market?

North America dominates the remifentanil hydrochloride market due to its robust healthcare infrastructure, advanced technological capabilities, and strong R&D prowess[5].

What are the key drivers of the remifentanil hydrochloride market growth?

Key drivers include an increasing prevalence of surgical procedures, advancements in anesthetic techniques, and a growing awareness of pain management solutions[3].

What are the contraindications for remifentanil hydrochloride?

Remifentanil hydrochloride is contraindicated for epidural or intrathecal administration and in patients with hypersensitivity to remifentanil[1].

Sources

1. FDA Label: "ULTIVA (remifentanil hydrochloride) for injection" - FDA.
2. FutureWise Research: "Remifentanil Hydrochloride Market Overview" - FutureWise Research.
3. GitHub: "Remifentanil Hydrochloride Market" - GitHub.
4. Lake Clinical Trial: "A Study to Evaluate the Safety and Efficacy of Remifentanil Hydrochloride" - Lake Clinical Trial.
5. Introspective Market Research: "Remifentanil Hydrochloride Market To Reach USD 337.7 Million by 2032" - Introspective Market Research.