CLINICAL TRIALS PROFILE FOR ULTIVA

505(b)(2) Clinical Trials for ULTIVA

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 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 Combination	NCT03089905 ↗	A Study to Compare the Long-term Outcomes After Two Different Anaesthetics	Recruiting	Children's Hospital of Philadelphia	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	Erasmus Medical Center	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	Flinders Medical Centre	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	Great Ormond Street Hospital for Children NHS Foundation Trust	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.

All Clinical Trials for ULTIVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00567957 ↗	Remifentanil for General Anesthesia in Preeclamptics	Unknown status	Istanbul University	Phase 4	2008-02-01	The purpose of this study is to determine whether remifentanil use in preeclamptic patients may blunt hemodynamic response to intubation during general anesthesia for cesarean section.
NCT00611195 ↗	Remifentanil and Laryngeal Reflex Responses in Pediatric Patients With URI	Completed	Thomas Erb	Phase 4	2008-01-01	To describe respiratory and laryngeal responses to laryngeal stimulation during propofol anesthesia in children with upper airway infections. To determine whether the co-administration of remifentanil blunts these reflex responses. To test whether the co-administration of remifentanil results in a significant reduction of apnea with laryngospasm in these patients. Hypotheses: I: In children with a URI undergoing anesthesia with propofol, the incidence of apnea and laryngospasm after controlled stimulation is expected to occur 2.5 times more frequently than in children without URI (20 vs. 8%). II: The incidence of apnea and laryngospasm is diminished after administration of remifentanil.
NCT00693160 ↗	Effect of Spinal Ketorolac After Acute Opioid Exposure	Terminated	National Institute of General Medical Sciences (NIGMS)	Phase 2	2007-12-01	This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller): 1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream? 2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
NCT00693160 ↗	Effect of Spinal Ketorolac After Acute Opioid Exposure	Terminated	Wake Forest School of Medicine	Phase 2	2007-12-01	This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller): 1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream? 2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
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.
NCT00615472 ↗	Intravenous Versus Inhalational Anesthesia in Parkinson's Disease	Terminated	Columbia University	N/A	2003-10-01	Parkinson's disease is a common progressive degenerative disease affecting 3% of all patients over the age of 65. Given their age and frailty, these patients frequently require surgical procedures with general anesthesia. However, after surgery, patients with Parkinson's disease have longer hospital stays and a greater chance of not returning to independent living compared to age-matched controls (Berman MF, unpublished data). In part, this is due to a higher rate of post-operative delirium, which had an incidence of 60% in this population in one study. There is anecdotal evidence from neurologists specializing in movement disorder suggesting that there is also significant deterioration in parkinsonian motor symptoms and cognition lasting for months or years following surgery and anesthesia. The basis for this deterioration is unknown. We hypothesize that these problems are caused by particular medications used during inhaled anesthesia for surgical procedures.

Clinical Trial Conditions for ULTIVA

Condition Name

Condition Name for ULTIVA
Intervention	Trials
Anesthesia	15
Pain	8
Drug Usage	4
Surgery	3

Condition MeSH

Condition MeSH for ULTIVA
Intervention	Trials
Hyperalgesia	5
Myocardial Ischemia	3
Coronary Artery Disease	3
Pain, Postoperative	3

Clinical Trial Locations for ULTIVA

Trials by Country

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−

Trials by Country for ULTIVA
Location	Trials
Korea, Republic of	19
United States	16
Turkey	12
Sweden	7
Norway	7

Trials by US State

+

−

Trials by US State for ULTIVA
Location	Trials
New York	2
Massachusetts	2
Texas	2
Oregon	2
Ohio	2

Clinical Trial Progress for ULTIVA

Clinical Trial Phase

Clinical Trial Phase for ULTIVA
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	5
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ULTIVA
Clinical Trial Phase	Trials
Completed	70
Unknown status	12
Recruiting	8

Clinical Trial Sponsors for ULTIVA

Sponsor Name

Sponsor Name for ULTIVA
Sponsor	Trials
Ajou University School of Medicine	8
Region Örebro County	4
KK Women's and Children's Hospital	4

Sponsor Type

Sponsor Type for ULTIVA
Sponsor	Trials
Other	174
Industry	6
NIH	1

ULTIVA (Remifentanil): Clinical Trials, Market Analysis, and Projections

Introduction to ULTIVA

ULTIVA, known chemically as remifentanil, is a potent, short-acting synthetic opioid analgesic drug. It is widely used in clinical settings for anesthesia and pain management due to its rapid onset and short duration of action.

Clinical Trials and Efficacy

Pharmacokinetics and Pharmacodynamics

ULTIVA is rapidly metabolized by nonspecific blood and tissue esterases, which ensures a quick onset and offset of its analgesic effects. Clinical trials have shown that ULTIVA has a rapid blood-brain equilibration half-time of approximately 1 minute and a terminal elimination half-life of 10 to 20 minutes, although the effective biological half-life is much shorter, ranging from 3 to 10 minutes[1].

Anesthesia and Pain Management

In several clinical trials, ULTIVA has been evaluated for its efficacy in various anesthesia settings. It has been used in monitored anesthesia care, general anesthesia, and as a primary agent for the induction of anesthesia, although it is recommended to use it in conjunction with other agents due to its potential to cause apnea, muscle rigidity, and tachycardia[1].

Comparative Studies

Studies comparing ULTIVA to other opioids like alfentanil and fentanyl have shown that ULTIVA results in fewer responses to intubation and intraoperative stimuli, although it may cause a higher incidence of hypotension. For example, in one study, doubling the infusion rate of ULTIVA before major surgical stress decreased the incidence of signs of light anesthesia significantly[1].

Intubation and Neuromuscular Blockers

A randomized trial compared the effect of ULTIVA versus neuromuscular blockers on successful intubation without major complications. The results indicated that while ULTIVA was effective, it was inferior to neuromuscular blockers in achieving successful intubation on the first attempt without major complications[4].

Market Analysis

Global Opioids Market

The global opioids market, which includes ULTIVA, was valued at $22.74 billion in 2023 and is expected to grow to $26.78 billion by 2034, with a CAGR of 1.5% from 2024 to 2034. The market is driven by the critical role opioids play in managing post-surgical pain, severe trauma, and other medical conditions[2].

Remifentanil Hydrochloride Market

Specifically, the remifentanil hydrochloride market, which is the active ingredient in ULTIVA, was valued at $280.09 million in 2023 and is projected to reach $337.7 million by 2032, growing at a CAGR of 2.10% from 2024 to 2032. North America dominates this market due to its robust healthcare infrastructure and advanced technological capabilities[5].

Market Segments

• Geographical Distribution: North America leads the market, followed by the Asia-Pacific region, which is expected to expand at the fastest CAGR during the forecast period[2][5].
• Application: The pain relief segment holds a significant market share, but the anesthesia segment is expected to grow at the fastest CAGR over the projected period[2].
• Route of Administration: The injectable segment holds the highest revenue share, with the oral segment anticipated to expand at a CAGR of 2.5% over the predicted period[2].
• Distribution Channel: Retail pharmacies lead the market, with a significant market share[2].

Key Insights

• The neurosurgery segment holds the largest share of the remifentanil hydrochloride market, accounting for 57.64% in 2023[5].
• The market is driven by the demand for effective pain management solutions, particularly in surgical settings where ULTIVA's rapid onset and short duration are crucial.

Projections and Future Outlook

Market Growth

The remifentanil hydrochloride market is expected to continue growing, driven by advancements in pain management and the increasing need for effective analgesics in surgical and post-surgical care. The CAGR of 2.10% from 2024 to 2032 indicates a steady and predictable growth trajectory[5].

Technological Advancements

The use of Target Controlled Infusion (TCI) with approved infusion devices incorporating the Minto PK model is expected to enhance the precision and safety of ULTIVA administration. This technology allows for better titration of the drug to optimize analgesia without delaying recovery[3].

Regulatory and Legal Developments

Recent developments, such as Teva's nationwide opioids settlement, highlight the ongoing regulatory scrutiny and legal considerations surrounding opioid use. However, these settlements also indicate a commitment to ensuring the safe and responsible use of opioids like ULTIVA[2].

Key Takeaways

• Rapid Onset and Offset: ULTIVA is characterized by its rapid onset and short duration of action, making it highly effective in clinical settings.
• Clinical Efficacy: Clinical trials have demonstrated ULTIVA's efficacy in various anesthesia settings, though it is often used in conjunction with other agents.
• Market Growth: The remifentanil hydrochloride market is projected to grow at a CAGR of 2.10% from 2024 to 2032, driven by demand in surgical and post-surgical care.
• Technological Advancements: The use of TCI and advanced infusion devices is expected to enhance the safety and efficacy of ULTIVA administration.
• Regulatory Considerations: Ongoing regulatory and legal developments emphasize the need for responsible use and distribution of opioids.

FAQs

What is ULTIVA used for?

ULTIVA (remifentanil) is used for anesthesia and pain management due to its rapid onset and short duration of action. It is particularly effective in surgical settings.

How is ULTIVA metabolized?

ULTIVA is rapidly metabolized by nonspecific blood and tissue esterases, which ensures a quick onset and offset of its analgesic effects.

What are the key market segments for ULTIVA?

The key market segments include geographical distribution (led by North America), application (with a significant share in pain relief and anesthesia), and route of administration (with injectable being the highest revenue share).

What is the projected market growth for remifentanil hydrochloride?

The remifentanil hydrochloride market is projected to grow from $280.09 million in 2023 to $337.7 million by 2032, with a CAGR of 2.10% from 2024 to 2032.

How does ULTIVA compare to other opioids in clinical trials?

ULTIVA has been shown to result in fewer responses to intubation and intraoperative stimuli compared to other opioids like alfentanil and fentanyl, although it may cause a higher incidence of hypotension.

What technological advancements are enhancing ULTIVA administration?

The use of Target Controlled Infusion (TCI) with approved infusion devices incorporating the Minto PK model is enhancing the precision and safety of ULTIVA administration.

Sources

1. FDA Label for ULTIVA: "ULTIVA (remifentanil hydrochloride) for injection" - FDA.
2. Opioids Market Size: "Opioids Market Size to Worth Around USD 26.78 Billion by 2034" - Biospace.
3. Australian Public Assessment Report for Remifentanil: "Australian Public Assessment Report for remifentanil (as hydrochloride)" - TGA.
4. Effect of Remifentanil vs Neuromuscular Blockers: "Effect of Remifentanil vs Neuromuscular Blockers During Rapid Sequence Intubation" - JAMA.
5. Remifentanil Hydrochloride Market: "Remifentanil Hydrochloride Market To Reach USD 337.7 Million by 2032" - Introspective Market Research.