CLINICAL TRIALS PROFILE FOR EPIPEN JR.

All Clinical Trials for EPIPEN JR.

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00434421 ↗	Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma	Completed	Inner-City Asthma Consortium	Phase 1	2007-02-01	Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
NCT00434421 ↗	Sublingual Cockroach Safety in Adults With Cockroach Allergy & Perennial Allergic Rhinitis With or Without Asthma	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	2007-02-01	Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.
NCT00809146 ↗	Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications	Completed	Medical University of South Carolina	Phase 3	2009-06-01	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
NCT00809146 ↗	Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 3	2009-06-01	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
NCT00809146 ↗	Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications	Completed	University of California, San Francisco	Phase 3	2009-06-01	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
NCT00809146 ↗	Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications	Completed	Robert Silbergleit	Phase 3	2009-06-01	The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
NCT01432522 ↗	A Study for Absorption of Intranasal Epinephrine Compared to Conventional Intramuscular Epinephrine	Completed	Mahidol University	N/A	2010-07-01	This study is a preliminary report of pharmacokinetic data of epinephrine administered via intranasal route (IN) comparing with intramuscular (IM) route in healthy adult volunteers.

Clinical Trial Conditions for EPIPEN JR.

Condition Name

Condition Name for EPIPEN JR.
Intervention	Trials
Anaphylaxis	2
Scoliosis	1
Dermatologic Surgery	1
Status Epilepticus	1

Condition MeSH

Condition MeSH for EPIPEN JR.
Intervention	Trials
Rhinitis, Allergic	2
Rhinitis	2
Anaphylaxis	2
Brain Edema	1

Clinical Trial Locations for EPIPEN JR.

Trials by Country

Trials by Country for EPIPEN JR.
Location	Trials
United States	40
Ukraine	1
Sweden	1
Serbia	1
Israel	1

Trials by US State

Trials by US State for EPIPEN JR.
Location	Trials
Maryland	4
New York	3
Wisconsin	2
Virginia	2
Texas	2

Clinical Trial Progress for EPIPEN JR.

Clinical Trial Phase

Clinical Trial Phase for EPIPEN JR.
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EPIPEN JR.
Clinical Trial Phase	Trials
Completed	8
Unknown status	1
Withdrawn	1

Clinical Trial Sponsors for EPIPEN JR.

Sponsor Name

Sponsor Name for EPIPEN JR.
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	2
Mahidol University	1
Siriraj Hospital	1

Sponsor Type

Sponsor Type for EPIPEN JR.
Sponsor	Trials
Other	10
Industry	5
NIH	3

EPIPEN JR. Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for EpiPen Jr.

Introduction to EpiPen Jr.

EpiPen Jr. is a critical medical device designed for the prehospital treatment of anaphylaxis, particularly in pediatric patients. It is an epinephrine auto-injector intended for children who weigh between 15 and 30 kilograms.

Clinical Trials and Efficacy

Efficacy of Outdated EpiPen Jr. Autoinjectors

Studies have evaluated the efficacy of outdated EpiPen Jr. autoinjectors to determine their usability beyond the expiration date. A study published in PubMed found that while most outdated EpiPen Jr. autoinjectors did not show significant discoloration or precipitates, the epinephrine bioavailability was significantly reduced compared to in-date autoinjectors. However, the study concluded that if no other option is available, an outdated EpiPen Jr. could still be used, as the potential benefit outweighs the risk of a suboptimal dose or no treatment at all[1].

User Usability Studies

Comparative studies have been conducted to assess the usability of EpiPen Jr. versus newer epinephrine auto-injectors. A meta-analysis of several trials showed that while there was no significant difference in the primary outcome of successful administration between EpiPen Jr. and newer devices like Auvi-Q, the completion of all steps to administer the device was significantly lower for EpiPen Jr. Additionally, patient preference was lower for EpiPen Jr. compared to other devices[5].

Market Analysis

Global Epinephrine Auto-Injectors Market

The global epinephrine auto-injectors market, which includes EpiPen Jr., is experiencing significant growth. In 2023, the market was valued at USD 2,136.2 million and is projected to reach USD 3,394.4 million by 2034, growing at a CAGR of 4.3% between 2024 and 2034[2].

Key Drivers of Market Growth

The increasing prevalence of drug-related and environmental allergies, particularly among children, is a major driver of the market. Allergies to peanuts, shellfish, and tree nuts, as well as insect stings and certain medications, are becoming more common, necessitating the use of epinephrine auto-injectors for immediate treatment[2].

Regional Market Analysis

The United States is expected to remain a leading market in North America, while India is projected to exhibit the highest CAGR of 4.9% in the Asia Pacific region. China is also expected to show significant growth, with a CAGR of 4.3% between 2024 and 2034[2].

Market Players

Key players in the global epinephrine auto-injectors market include Adamis Pharmaceuticals Corporation, Alk-Abello A/S, Impax Laboratories, Inc., Viatris, and Antares Pharma. These companies are investing in research and development to introduce innovative and user-friendly epinephrine delivery systems[2].

Market Projections

Global Epinephrine Market

The global epinephrine market, which encompasses epinephrine auto-injectors like EpiPen Jr., is projected to grow from $2.6 billion in 2022 to $4.4 billion by 2032, at a CAGR of 5.6% from 2023 to 2032. This growth is driven by the increasing incidence of cardiovascular diseases and the rising aging population[3].

Epinephrine for Anaphylaxis Treatment Market

The global epinephrine for anaphylaxis treatment market is expected to grow from $1.67 billion in 2024 to $3.32 billion by 2032, at a CAGR of 9.0%. This growth is fueled by the increasing prevalence of anaphylaxis, rising research and development activities, and the introduction of novel drug delivery systems[4].

Advanced Drug Delivery Systems

Innovations in Epinephrine Auto-Injectors

The market is witnessing significant advancements in drug delivery systems, making epinephrine auto-injectors more user-friendly. Features such as voice prompts, clearer instructions, and compact designs are enhancing the usability of these devices, even for individuals without medical training. These innovations are expected to improve patient outcomes and drive market growth[2].

Key Takeaways

• Efficacy of Outdated Devices: Outdated EpiPen Jr. autoinjectors may still be used in emergency situations, though their epinephrine bioavailability is reduced.
• Market Growth: The global epinephrine auto-injectors market is projected to grow significantly, driven by increasing allergy prevalence and advancements in drug delivery systems.
• Regional Trends: The United States, India, and China are expected to be key markets, with India showing the highest CAGR.
• Innovations: Advanced features in new epinephrine auto-injectors are improving usability and patient outcomes.

FAQs

What is the projected growth rate of the global epinephrine auto-injectors market?

The global epinephrine auto-injectors market is projected to grow at a CAGR of 4.3% from 2024 to 2034[2].

Can outdated EpiPen Jr. autoinjectors still be used?

Yes, outdated EpiPen Jr. autoinjectors can still be used in emergency situations if no other option is available, despite reduced epinephrine bioavailability[1].

Which regions are expected to lead the market growth for epinephrine auto-injectors?

The United States, India, and China are expected to be key regions driving market growth, with India exhibiting the highest CAGR of 4.9%[2].

What are the key drivers of the epinephrine auto-injectors market?

The increasing prevalence of allergies, advancements in drug delivery systems, and the growing need for emergency treatments are key drivers of the market[2][4].

How are new epinephrine auto-injectors improving patient outcomes?

New devices feature voice prompts, clearer instructions, and compact designs, making them easier to use even for individuals without medical training, thus improving patient outcomes[2].

Sources

1. Outdated EpiPen and EpiPen Jr autoinjectors: past their prime? - PubMed
2. Epinephrine Auto-Injectors Market Update: Key Developments - Future Market Insights
3. Epinephrine Market Size, Share | Segments | Forecast - 2033 - Allied Market Research
4. Epinephrine for Anaphylaxis Treatment Market Size, Share [2032] - Fortune Business Insights
5. Gainwell Technologies - Therapeutic Class Review - Texas Health and Human Services