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Last Updated: March 31, 2025

CLINICAL TRIALS PROFILE FOR VOLMAX


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All Clinical Trials for VOLMAX

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00550550 ↗ Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) Completed ALK-Abelló A/S Phase 3 2007-11-01 The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
NCT00550550 ↗ Efficacy and Safety of Grass Sublingual Tablet in Children and Adolescents (P05239 AM3)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2007-11-01 The purpose of the study is to investigate the efficacy and safety of a grass sublingual tablet in children and adolescents with a history of grass-pollen induced rhinoconjunctivitis with or without asthma.
NCT00562159 ↗ Efficacy and Safety of Grass Sublingual Tablet in Adults (P05238 AM3)(COMPLETED) Completed ALK-Abelló A/S Phase 3 2007-11-01 This purpose of this study is to determine the efficacy and safety of a grass sublingual (under-the-tongue) tablet.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for VOLMAX

Condition Name

2220-0.200.20.40.60.811.21.41.61.822.2AllergyConjunctivitisRhinitis[disabled in preview]
Condition Name for VOLMAX
Intervention Trials
Allergy 2
Conjunctivitis 2
Rhinitis 2
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Condition MeSH

220-0.200.20.40.60.811.21.41.61.822.2RhinitisConjunctivitis[disabled in preview]
Condition MeSH for VOLMAX
Intervention Trials
Rhinitis 2
Conjunctivitis 2
[disabled in preview] 0
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Clinical Trial Progress for VOLMAX

Clinical Trial Phase

100.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 3[disabled in preview]
Clinical Trial Phase for VOLMAX
Clinical Trial Phase Trials
Phase 3 2
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Clinical Trial Status

100.0%0-0.200.20.40.60.811.21.41.61.822.2Completed[disabled in preview]
Clinical Trial Status for VOLMAX
Clinical Trial Phase Trials
Completed 2
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Clinical Trial Sponsors for VOLMAX

Sponsor Name

trials000111112222Merck Sharp & Dohme Corp.ALK-Abelló A/S[disabled in preview]
Sponsor Name for VOLMAX
Sponsor Trials
Merck Sharp & Dohme Corp. 2
ALK-Abelló A/S 2
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Sponsor Type

100.0%000.511.522.533.54Industry[disabled in preview]
Sponsor Type for VOLMAX
Sponsor Trials
Industry 4
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VOLMAX: Clinical Trials, Market Analysis, and Projections

Introduction to VOLMAX

VOLMAX is an extended-release formulation of albuterol, a medication commonly used to treat asthma and other respiratory conditions. It is designed to provide a more controlled release of albuterol, ensuring consistent therapeutic effects over an extended period.

Pharmacokinetic Profile of VOLMAX

Studies have compared the pharmacokinetic profile of VOLMAX with another extended-release formulation, Proventil Repetabs. A randomized, two-way, crossover study involving 23 healthy men showed that VOLMAX exhibited a more controlled release of albuterol during both daytime and nighttime dosing intervals compared to Proventil Repetabs. This resulted in significantly less peak-trough fluctuation, indicating a more stable and predictable drug delivery[1].

Clinical Trials Involving VOLMAX

While specific clinical trials focused solely on VOLMAX are limited, the drug's performance in comparative studies highlights its efficacy and safety profile. For instance, the study mentioned earlier demonstrated that VOLMAX had no significant differences in reported adverse experiences compared to Proventil Repetabs, suggesting a favorable safety profile[1].

However, for a comprehensive understanding of clinical trials in the broader context of respiratory medications, it is important to note that many clinical trials are ongoing for various respiratory conditions. For example, Phase III trials for other respiratory treatments often involve large patient populations and extensive follow-up periods, similar to what would be expected for VOLMAX if it were to be tested in a large-scale clinical setting[3].

Market Analysis of Extended-Release Albuterol Formulations

The market for respiratory medications, including extended-release albuterol formulations like VOLMAX, is significant and growing. Here are some key points:

Market Size and Growth

The global pharmaceutical market, which includes respiratory medications, has seen substantial growth. Although specific figures for VOLMAX are not available, the broader market for respiratory drugs is part of a larger pharmaceutical industry that was valued at over $1 trillion in recent years. The clinical trials market, which includes trials for respiratory medications, was valued at USD 80.7 billion in 2023 and is projected to grow at a CAGR of 6.49% from 2024 to 2030[3].

Competitive Landscape

VOLMAX competes with other extended-release albuterol formulations such as Proventil Repetabs. The competitive landscape is driven by factors such as efficacy, safety, patient compliance, and cost. VOLMAX's more controlled release profile could be a significant differentiator in the market[1].

Patient Needs and Preferences

Patients with chronic respiratory conditions often prefer medications that offer consistent therapeutic effects with minimal peak-trough fluctuations. VOLMAX's pharmacokinetic profile addresses this need, potentially increasing patient compliance and satisfaction.

Projections for VOLMAX

Market Potential

Given its favorable pharmacokinetic profile, VOLMAX has the potential to capture a significant share of the extended-release albuterol market. As the global demand for effective and convenient respiratory medications continues to grow, VOLMAX is well-positioned to meet this demand.

Regulatory and Approval Pathways

To fully realize its market potential, VOLMAX must navigate regulatory approval processes. Successful completion of clinical trials and regulatory approvals will be crucial for its widespread adoption.

Technological Advancements

Advancements in drug delivery systems, such as the oral osmotic drug delivery system used in VOLMAX, are expected to continue driving innovation in the pharmaceutical industry. These advancements could further enhance the efficacy and patient compliance of VOLMAX.

Key Takeaways

  • Pharmacokinetic Profile: VOLMAX exhibits a more controlled release of albuterol compared to other extended-release formulations.
  • Clinical Trials: While specific trials for VOLMAX are limited, its performance in comparative studies is promising.
  • Market Analysis: The market for respiratory medications is growing, and VOLMAX has the potential to capture a significant share.
  • Projections: Successful regulatory approvals and continued technological advancements will be key to VOLMAX's market success.

FAQs

Q: What is the active ingredient in VOLMAX?

A: The active ingredient in VOLMAX is albuterol sulfate, a relatively selective beta2-adrenergic bronchodilator[5].

Q: How does VOLMAX compare to Proventil Repetabs in terms of pharmacokinetics?

A: VOLMAX exhibits significantly less peak-trough fluctuation during both daytime and nighttime dosing intervals compared to Proventil Repetabs[1].

Q: What is the market size and growth projection for the clinical trials market?

A: The global clinical trials market was valued at USD 80.7 billion in 2023 and is projected to grow at a CAGR of 6.49% from 2024 to 2030[3].

Q: What are the potential benefits of VOLMAX for patients?

A: VOLMAX offers a more controlled release of albuterol, which can lead to consistent therapeutic effects and improved patient compliance[1].

Q: What are the regulatory steps required for VOLMAX to enter the market?

A: VOLMAX must complete clinical trials and obtain regulatory approvals to enter the market successfully.

Sources

  1. Albuterol extended-release products: a comparison of steady-state pharmacokinetics. PubMed.
  2. DRUG MARKET TRENDS. UNODC.
  3. Clinical Trials Market Size, Share And Growth Report, 2030. Grand View Research.
  4. VOLGA - AstraZeneca Clinical Trials. AstraZeneca Clinical Trials.
  5. Volmax | Drug Information, Uses, Side Effects, Chemistry. PharmaCompass.

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