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Last Updated: January 9, 2025

CLINICAL TRIALS PROFILE FOR EPINEPHRINE (AUTOINJECTOR)


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All Clinical Trials for EPINEPHRINE (AUTOINJECTOR)

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03964051 ↗ Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). Active, not recruiting Miltenyi Biomedicine GmbH Phase 4 2019-07-01 Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen. Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.
NCT03964051 ↗ Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). Active, not recruiting Miltenyi Biotec GmbH Phase 4 2019-07-01 Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen. Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.
NCT03964051 ↗ Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana). Active, not recruiting Carsten Bindslev-Jensen Phase 4 2019-07-01 Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen. Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.
NCT05166343 ↗ POHCA Resuscitation: Evaluation of IM Epinephrine Not yet recruiting Lawson Health Research Institute Phase 2/Phase 3 2022-01-01 This is a pragmatic, two-arm, open-label, prospective stepped-wedge cluster randomized control trial (SW-CRCT) looking to evaluate early intramuscular (IM) epinephrine in the management of pediatric out-of-hospital cardiac arrest (POHCA).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for EPINEPHRINE (AUTOINJECTOR)

Condition Name

Condition Name for EPINEPHRINE (AUTOINJECTOR)
Intervention Trials
Food Allergy 1
Pediatric Out-of-Hospital Cardiac Arrest 1
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Condition MeSH

Condition MeSH for EPINEPHRINE (AUTOINJECTOR)
Intervention Trials
Out-of-Hospital Cardiac Arrest 1
Heart Arrest 1
Food Hypersensitivity 1
Anaphylaxis 1
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Clinical Trial Locations for EPINEPHRINE (AUTOINJECTOR)

Trials by Country

Trials by Country for EPINEPHRINE (AUTOINJECTOR)
Location Trials
Denmark 1
Canada 1
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Clinical Trial Progress for EPINEPHRINE (AUTOINJECTOR)

Clinical Trial Phase

Clinical Trial Phase for EPINEPHRINE (AUTOINJECTOR)
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for EPINEPHRINE (AUTOINJECTOR)
Clinical Trial Phase Trials
Active, not recruiting 1
Not yet recruiting 1
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Clinical Trial Sponsors for EPINEPHRINE (AUTOINJECTOR)

Sponsor Name

Sponsor Name for EPINEPHRINE (AUTOINJECTOR)
Sponsor Trials
Miltenyi Biomedicine GmbH 1
Miltenyi Biotec GmbH 1
Carsten Bindslev-Jensen 1
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Sponsor Type

Sponsor Type for EPINEPHRINE (AUTOINJECTOR)
Sponsor Trials
Industry 2
Other 2
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EPINEPHRINE (AUTOINJECTOR) Market Analysis and Financial Projection

Epinephrine Autoinjectors: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update for Epinephrine Autoinjectors

Anaphylm (Epinephrine) Sublingual Film: A New Horizon

Aquestive Therapeutics is on the cusp of a significant milestone with its novel epinephrine product, Anaphylm, a sublingual film designed for the treatment of severe allergic reactions, including anaphylaxis. The company has received positive feedback from the FDA regarding its planned new drug application (NDA) submission, which is slated for early 2025[1].

  • FDA Alignment: The FDA has agreed with the content and format of the NDA submission and endorsed the planned safety evaluation and the design of the single-dose pediatric trial currently underway in the US and Canada[1].
  • No Additional Adult Trials Required: The FDA does not require additional adult clinical trials before the NDA submission, given the new route of administration and supporting data. However, there may be a need for an advisory committee meeting prior to a final decision[1].
  • Pediatric Trials: The pharmacokinetic/pharmacodynamic (PK/PD) pediatric trial has commenced, providing a clear path to the NDA submission in Q1 2025[1].

Traditional Epinephrine Autoinjectors

While Anaphylm represents a new delivery method, traditional epinephrine autoinjectors continue to be a crucial part of emergency treatment for anaphylaxis.

  • Ongoing Research and Development: Companies are continuously improving autoinjector designs, incorporating technological advancements such as smart autoinjectors with digital connectivity for dose tracking and reminders. These innovations aim to enhance user experience and adherence to treatment protocols[4].

Market Analysis for Epinephrine Autoinjectors

Market Size and Growth

The epinephrine autoinjector market is experiencing robust growth driven by several key factors.

  • Current Market Size: The global epinephrine autoinjector market was valued at USD 1.88 billion in 2021 and is projected to reach USD 3.56 billion by 2029, growing at a CAGR of 8.30% during the forecast period[3].
  • Forecast: By 2030, the market is expected to continue its upward trajectory, with some estimates suggesting it could reach USD 3.02 billion, driven by a CAGR of 13.6% in the broader autoinjectors market[5].

Market Drivers

Several factors are driving the growth of the epinephrine autoinjector market.

  • Rising Prevalence of Allergies: The increasing incidence of allergies and anaphylaxis, particularly in regions like North America, is a significant driver. For instance, between 1.6% and 5.1% of US citizens annually experience anaphylaxis or suffer from this condition[2].
  • Technological Developments: Innovations in autoinjector design, such as improved usability, connectivity features, and the use of hydrofluoroalkane propellants, are enhancing market growth[4][5].
  • Awareness and Self-Administration: Growing awareness about anaphylaxis and the importance of self-administration of epinephrine autoinjectors as a first line of treatment are also key drivers[2][3].

Market Restraints

Despite the growth, the market faces several challenges.

  • High Costs: The high cost of autoinjectors and issues with insurance coverage are significant restraints. Product recalls due to malfunctions also impede market growth[4].
  • Competition and Alternatives: The presence of multiple alternatives for injections and the competitive nature of the market can also pose challenges[2].

Geographical Insights

  • North America: This region is expected to hold a significant share of the global disposable auto-injectors market due to the easy availability of products, favorable reimbursement policies, and a high incidence of anaphylaxis[2].
  • Asia-Pacific: This region is identified as the fastest-growing market, driven by increasing healthcare infrastructure and growing awareness about allergies[2].

Market Projections

Future Growth

The epinephrine autoinjector market is poised for substantial growth over the next few years.

  • CAGR: The market is expected to grow at a CAGR of 8.5% to 13.6% depending on the broader autoinjectors market context[2][5].
  • Market Value: By 2030, the global autoinjectors market, including epinephrine autoinjectors, is projected to reach USD 3.02 billion from USD 1.40 billion in 2024[5].

Opportunities and Challenges

  • Opportunities: There is a significant opportunity for creating more cost-effective solutions, improving device usability, and developing injectors with extended shelf lives. Educational campaigns to improve public understanding of device use are also crucial[4].
  • Challenges: Stringent regulations, high device costs, and product recalls are challenges that need to be addressed to ensure sustained market growth[4].

Technological Advancements

Technological advancements are a key factor in the growth of the epinephrine autoinjector market.

  • Smart Autoinjectors: The integration of digital connectivity, Bluetooth connectivity, and dosage reminders is enhancing user experience and adherence to treatment protocols[5].
  • Improved Designs: Innovations in design, such as chlorofluorocarbon-free auto-injector inhalers using hydrofluoroalkane propellants, are making autoinjectors more appealing and effective[4].

Regulatory and Reimbursement Environment

Favorable regulatory and reimbursement policies play a crucial role in the adoption of epinephrine autoinjectors.

  • Government Initiatives: Supportive government regulations and initiatives to boost the accessibility of autoinjectors provide substantial opportunities for growth. Efforts to lower the cost of epinephrine delivery devices and expand product availability in developing regions are also beneficial[4].
"Technological advancements in autoinjector devices, such as improved design, the addition of connectivity features for data tracking, Bluetooth connectivity, and dosage reminders, are some of the factors that increase the adoption of autoinjectors and drive market growth."[5]

Key Takeaways

  • Clinical Trials: Anaphylm, a sublingual epinephrine film, is on track for NDA submission in Q1 2025, with positive feedback from the FDA.
  • Market Growth: The epinephrine autoinjector market is expected to grow significantly, driven by rising allergies, technological developments, and increasing awareness.
  • Market Size: The global market is projected to reach USD 3.56 billion by 2029 and USD 3.02 billion by 2030 in the broader autoinjectors market.
  • Technological Advancements: Smart autoinjectors and improved designs are key drivers of market growth.
  • Regulatory Environment: Favorable regulatory and reimbursement policies are crucial for market expansion.

FAQs

What is the current status of Anaphylm (epinephrine) sublingual film?

Anaphylm is on track for NDA submission in Q1 2025, with the FDA agreeing on the content and format of the submission and endorsing the planned safety evaluation and pediatric trial design[1].

What are the key drivers of the epinephrine autoinjector market?

The key drivers include the rising prevalence of allergies, technological developments, increasing awareness about anaphylaxis, and favorable regulatory and reimbursement policies[2][3][5].

Which region is expected to dominate the epinephrine autoinjector market?

North America is expected to hold a significant share of the global disposable auto-injectors market due to favorable reimbursement policies and a high incidence of anaphylaxis[2].

What are the challenges facing the epinephrine autoinjector market?

High device costs, issues with insurance coverage, product recalls, and stringent regulations are significant challenges[4].

How is technology impacting the epinephrine autoinjector market?

Technological advancements such as smart autoinjectors with digital connectivity, improved designs, and the use of hydrofluoroalkane propellants are driving market growth and enhancing user experience[4][5].

Sources

  1. Aquestive Therapeutics. NDA Submission for Anaphylm (Epinephrine) Sublingual Film on Track for Q1 2025, Company Says. Patient Care Online, 2024.
  2. Mordor Intelligence. Epinephrine Autoinjector Market Size & Share Analysis. Mordor Intelligence, 2023.
  3. Data Bridge Market Research. Global Epinephrine Auto-Injector Market – Industry Trends and Forecast to 2029. Data Bridge Market Research, 2023.
  4. Research and Markets. Epinephrine Auto-Injector Market Size & Forecast to 2030. Research and Markets, 2023.
  5. MarketsandMarkets. Autoinjectors Market Growth, Drivers, and Opportunities. MarketsandMarkets, 2023.

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