CLINICAL TRIALS PROFILE FOR NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

All Clinical Trials for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02654847 ↗	Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2016-01-01	Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac output, which may be a concern in an already compromised fetus. Norepinephrine is commonly used in high concentrations in intensive care and recent studies have suggested that in low concentrations it may be a better alternative to phenylephrine in elective CD, as it does not reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The investigators propose this study to determine the dose that would be effective in 90% of patients (ED90). A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately 6 µg, given that the current phenylephrine bolus dose at the investigators' institution is approximately 100 µg.
NCT02962986 ↗	A Comparison of Intermittent Intravenous Boluses of Phenylephrine and Norepinephrine to Prevent Spinal-induced Hypotension in Cesarean Deliveries	Completed	Samuel Lunenfeld Research Institute, Mount Sinai Hospital	N/A	2017-01-01	Hypotension is a very common complication of spinal anesthesia for cesarean delivery, and can have unwanted side effects on both mother and fetus if not treated promptly. Phenylephrine has been the drug of choice to treat this spinal-induced hypotension. Although phenylephrine is safe to use for this indication, it has been associated with reflex bradycardia and a reduction in cardiac output. Norepinephrine is a potent vasopressor used to treat hypotension in the critical care setting. Recent studies have looked at norepinephrine's use in the obstetric setting, and have shown that it can be used safely and also has favourable hemodynamic properties when compared to phenylephrine, with less bradycardia and less depression of cardiac output. The investigators recently conducted a study to determine the ED90 of norepinephrine, and now plan to compare bolus doses of phenylephrine to norepinephrine for treating hypotension following spinal anesthesia for cesarean section. The investigators hypothesize that norepinephrine, when given as a bolus to prevent post spinal hypotension, will result in around 70% relative decrease in the rate of bradycardia when compared to phenylephrine in patients undergoing elective cesarean delivery under spinal anesthesia.
NCT03328533 ↗	Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery	Completed	Cairo University	Phase 4	2017-11-10	Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery
NCT03706755 ↗	Comparison of Two Doses of Norepinephrine in Preventing Hypotension After Spinal Anesthesia	Completed	University Tunis El Manar	Phase 4	2018-05-03	The purpose of the study is to determine the more effective intravenous bolus of norepinephrine for maintaining blood pressure during a spinal anesthesia for a cesarean delivery with the fewer side effects. Low blood pressure has been shown to decrease uterine perfusion and foetal outcomes during cesarean delivery under spinal anesthesia. For elective or semi-urgent cesarean delivery, all participants will receive spinal anesthesia with a local anesthetic and either sufentanil or fentanyl. This study plans to enroll 124 pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.
NCT05355974 ↗	Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure	Not yet recruiting	Wright State University	Phase 3	2022-06-01	The purpose of this study is to investigate whether protocolized vasopressor use for patients with normal blood pressure undergoing rapid sequence intubation improves hemodynamic parameters and mitigates adverse events. The hypothesis is that use of vasopressors during Rapid Sequence Intubation will prevent substantial decreases in blood pressure when compared to normal intravenous fluids.

Clinical Trial Conditions for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Condition Name

Condition Name for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Intervention	Trials
Hypotension	3
Anesthesia	2
Cesarean Section Complications	2
Norepinephrine	1

Condition MeSH

Condition MeSH for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Intervention	Trials
Hypotension	6
Toxemia	1
Sepsis	1
Biliary Atresia	1

Clinical Trial Locations for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Trials by Country

Trials by Country for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Location	Trials
Canada	3
Tunisia	2
Egypt	2
United States	1
China	1

Trials by US State

Trials by US State for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Location	Trials
Ohio	1

Clinical Trial Progress for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Clinical Trial Phase

Clinical Trial Phase for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
N/A	3

Clinical Trial Status

Clinical Trial Status for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Clinical Trial Phase	Trials
Completed	4
Recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

Sponsor Name

Sponsor Name for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Sponsor	Trials
Samuel Lunenfeld Research Institute, Mount Sinai Hospital	2
Wright State University	1
Kasr El Aini Hospital	1

Sponsor Type

Sponsor Type for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE
Sponsor	Trials
Other	9

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE Market Analysis and Financial Projection

Norepinephrine Bitartrate in 5% Dextrose Injection: Clinical Trials, Market Analysis, and Projections

Introduction

Norepinephrine Bitartrate in 5% Dextrose Injection is a critical medication for managing severe, acute hypotension in adult patients. Recently approved by the U.S. Food and Drug Administration (FDA), this ready-to-use formulation has significant implications for both clinical practice and the pharmaceutical market.

Clinical Trials and Safety Profile

Non-Clinical Studies

The non-clinical studies for Norepinephrine Bitartrate in 5% Dextrose Injection involved extensive testing on rats to evaluate its safety and efficacy. These studies, conducted under Good Laboratory Practice (GLP) compliance, showed that the intravenous administration of the drug at a dose of 74 µg/kg/hr for 14 days was well tolerated in rats. Key findings included minor decreases in body weight gains and food consumption, changes in clinical chemistry, and decreases in spleen weight, which were comparable to the reference article (Levophed)[1].

Lack of Mortality and Adverse Effects

There was no mortality observed due to the test article, and all animals survived to their scheduled sacrifice. The study also found no significant ophthalmic findings or micronucleus induction, indicating no mutagenic potential[1].

Clinical Chemistry and Pathology

The clinical chemistry and pathology results showed changes that were consistent with the effects of norepinephrine but were not significantly different from the reference article. This suggests that the new formulation does not introduce new or unexpected adverse effects[1].

Market Analysis

Product Innovation

Baxter International Inc.'s introduction of the premix Norepinephrine Bitartrate in 5% Dextrose Injection marks a significant innovation in the dextrose market. This ready-to-use formulation addresses the need for convenient and error-free administration of norepinephrine, particularly in critical care settings[2][4].

Market Trends

The global dextrose market is trending towards product innovations, with companies developing cutting-edge formulations to maintain their market position. Baxter's premix norepinephrine solution is a prime example of this trend, offering a convenient, pre-mixed alternative to traditional formulations that require dilution before use[2].

Competitive Advantage

The ready-to-use nature of Baxter's Norepinephrine Bitartrate in 5% Dextrose Injection provides several competitive advantages. It minimizes the risk of medication errors due to compounding, reduces wait times for drug administration, and allows for room temperature storage near the point of care. These features enhance patient safety and streamline clinical workflows[5].

Market Projections

Demand and Growth

Given the critical nature of norepinephrine in managing acute hypotension, the demand for this medication is expected to remain high. The COVID-19 pandemic has highlighted the importance of reliable and readily available critical care medications, which is likely to drive growth in this segment. Baxter's premix formulation is well-positioned to capture a significant share of this market due to its convenience and safety profile[3][4].

Market Size and Share

The global dextrose market, which includes various dextrose-based formulations, is expected to grow steadily. With the introduction of innovative products like Baxter's premix norepinephrine solution, the market is likely to see increased competition and innovation. Baxter's strong presence in the healthcare industry and the unique benefits of its premix formulation suggest a significant market share potential[2].

Storage and Shelf Life

Convenience in Storage

Baxter's Norepinephrine Bitartrate in 5% Dextrose Injection offers a refrigerator shelf life of up to 21 months and a room temperature shelf life of up to 90 days in overwrap. This flexibility in storage conditions makes it easier to manage inventory and ensure availability at the point of care[2][5].

Regulatory Approval and Launch

FDA Approval

The FDA approved Baxter's Norepinephrine Bitartrate in 5% Dextrose Injection under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. This approval was expedited due to the potential drug shortage related to the COVID-19 pandemic, highlighting the critical need for this medication[3][4].

Commercial Launch

Following FDA approval, Baxter launched the product commercially, making it available in two strengths: 4 mg/250 mL and 8 mg/250 mL. This launch marked the first and only manufacturer-prepared ready-to-use norepinephrine formulation available in the market[4].

Key Takeaways

• Clinical Safety: Norepinephrine Bitartrate in 5% Dextrose Injection has been shown to be well-tolerated in non-clinical studies with no significant adverse effects.
• Market Innovation: The ready-to-use formulation addresses critical needs in the dextrose market, reducing medication errors and wait times.
• Market Growth: The demand for this medication is expected to grow, driven by its critical role in managing acute hypotension and the convenience of the premix formulation.
• Regulatory Approval: FDA approval under Section 505(b)(2) and expedited review highlight the importance of this medication.
• Storage and Shelf Life: The product offers flexible storage options, enhancing its availability and manageability.

FAQs

Q: What is the primary indication for Norepinephrine Bitartrate in 5% Dextrose Injection?

A: The primary indication is to raise blood pressure in adult patients with severe, acute hypotension[4][5].

Q: What are the key benefits of the ready-to-use premix formulation?

A: The benefits include minimized risk of medication errors, reduced wait times for drug administration, and room temperature storage near the point of care[5].

Q: How does the new formulation compare to traditional norepinephrine formulations?

A: The new formulation does not require dilution before use, which reduces the risk of compounding errors and streamlines clinical workflows[3][5].

Q: What are the storage conditions for Norepinephrine Bitartrate in 5% Dextrose Injection?

A: The product has a refrigerator shelf life of up to 21 months and a room temperature shelf life of up to 90 days in overwrap[2][5].

Q: Why was the FDA review for this product expedited?

A: The FDA review was expedited due to the potential drug shortage related to the COVID-19 pandemic[3].

Sources

1. FDA Non-Clinical Review: "214313Orig1s000 NON-CLINICAL REVIEW(S)" - FDA.
2. Global Dextrose Market Report: "Global Dextrose Market Trend" - The Business Research Company.
3. FDA Summary Review: "214313Orig1s000" - FDA.
4. Baxter Press Release: "Baxter Announces U.S. Approval and Launch of Ready-To-Use Cardiovascular Medicine" - Baxter.
5. Baxter Product Information: "Norepinephrine Bitartrate in 5% Dextrose Injection" - Baxter.