CLINICAL TRIALS PROFILE FOR DECASPRAY

All Clinical Trials for Decaspray

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00895245 ↗	Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy	Terminated	National Cancer Institute (NCI)	Phase 2	2009-02-01	RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
NCT00895245 ↗	Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy	Terminated	University of Washington	Phase 2	2009-02-01	RATIONALE: Fosaprepitant dimeglumine, palonosetron hydrochloride, and dexamethasone may help lessen or prevent nausea and vomiting caused by cisplatin in patients with head and neck cancer undergoing chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying how well fosaprepitant dimeglumine together with palonosetron hydrochloride and dexamethasone works in preventing nausea and vomiting caused by cisplatin in patients with stage III or stage IV head and neck cancer undergoing chemotherapy and radiation therapy.
NCT01049945 ↗	Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma	Completed	Mayo Clinic	Phase 1/Phase 2	2010-02-01	RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Giving bendamustine hydrochloride together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride and lenalidomide when given together with dexamethasone and to see how well they work in treating patients with relapsed multiple myeloma.
NCT01057225 ↗	Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma	Completed	Mayo Clinic	Phase 1/Phase 2	2010-03-01	RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the tumor. Giving combination chemotherapy together with carfilzomib and thalidomide may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of carfilzomib when given together with cyclophosphamide, thalidomide, and dexamethasone in treating patients with newly diagnosed active multiple myeloma.
NCT01072773 ↗	Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis	Completed	Mayo Clinic	Phase 2	2010-03-01	RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib, cyclophosphamide, and dexamethasone together works in treating patients with primary systemic light chain amyloidosis.

Clinical Trial Conditions for Decaspray

Condition Name

Condition Name for Decaspray
Intervention	Trials
Refractory Multiple Myeloma	3
Multiple Myeloma	2
Stage III Multiple Myeloma	1
Stage III Squamous Cell Carcinoma of the Hypopharynx	1

Condition MeSH

Condition MeSH for Decaspray
Intervention	Trials
Neoplasms, Plasma Cell	5
Multiple Myeloma	5
Nasopharyngeal Neoplasms	1
Nasopharyngeal Carcinoma	1

Clinical Trial Locations for Decaspray

Trials by Country

Trials by Country for Decaspray
Location	Trials
United States	23

Trials by US State

Trials by US State for Decaspray
Location	Trials
Minnesota	5
Ohio	2
Arizona	2
Missouri	2
Florida	2

Clinical Trial Progress for Decaspray

Clinical Trial Phase

Clinical Trial Phase for Decaspray
Clinical Trial Phase	Trials
Phase 2	3
Phase 1/Phase 2	4

Clinical Trial Status

Clinical Trial Status for Decaspray
Clinical Trial Phase	Trials
Completed	5
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for Decaspray

Sponsor Name

Sponsor Name for Decaspray
Sponsor	Trials
Mayo Clinic	4
National Cancer Institute (NCI)	3
Case Comprehensive Cancer Center	1

Sponsor Type

Sponsor Type for Decaspray
Sponsor	Trials
Other	8
NIH	3
Industry	1

DECASPRAY: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

DECASPRAY, a topical aerosol formulation of dexamethasone, was initially approved by the FDA in 1961 for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. However, the product has since been discontinued. Here, we will delve into the historical context, clinical trials, market analysis, and projections related to DECASPRAY and similar dexamethasone formulations.

Historical Context of DECASPRAY

DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, was first approved on March 29, 1961, based solely on safety grounds. Following the 1962 amendments to the FD&C Act, which required drugs to be shown effective as well, the FDA conducted the Drug Efficacy Study Implementation (DESI) review. This review concluded that DECASPRAY was effective for certain indications, but it was eventually discontinued by Merck & Co., Inc. in 2003[1].

Clinical Trials and Efficacy

Although DECASPRAY itself is no longer in use, dexamethasone remains a widely studied and used corticosteroid. Recent clinical trials have focused on various applications of dexamethasone, including its use in COVID-19 treatment and postoperative care.

• COVID-19 Treatment: Studies have shown mixed results regarding the duration of dexamethasone treatment in severe COVID-19 cases. A multicenter study indicated that extended duration of dexamethasone compared to standard duration was associated with increased in-hospital mortality, highlighting the need for further randomized controlled trials[5].
• Postoperative Care: A randomized, double-blind, placebo-controlled trial demonstrated that a single preoperative low dose of dexamethasone can improve early postoperative pain, function, nausea, and vomiting after primary total knee arthroplasty[5].

Market Analysis

Given that DECASPRAY is no longer on the market, the analysis shifts to the broader context of dexamethasone and similar corticosteroids.

Global Corticosteroid Market

The global market for corticosteroids, including topical and systemic formulations, is significant. However, DECASPRAY's discontinuation means it does not contribute to current market dynamics.

Related Markets

• Non-Small Cell Lung Cancer (NSCLC) Market: While not directly related to DECASPRAY, the NSCLC market is an example of a growing pharmaceutical market where corticosteroids like dexamethasone may be used as part of treatment regimens. The NSCLC market is projected to grow significantly, reaching $26.8 billion by 2025, driven by increased incidence and advancements in targeted therapies[3].

Clinical Trials Market

The global clinical trials market, which includes trials for various drugs including corticosteroids, was valued at $80.7 billion in 2023 and is expected to grow at a CAGR of 6.49% from 2024 to 2030. This growth is fueled by technological advancements, the rise of personalized medicine, and increased R&D investments[4].

Projections and Future Outlook

Since DECASPRAY is no longer available, projections are not applicable directly to this product. However, here are some broader projections relevant to the pharmaceutical industry and corticosteroids:

Corticosteroid Use in Emerging Markets

The use of corticosteroids, including dexamethasone, is expected to continue in various therapeutic areas. Emerging markets, particularly in Asia, are anticipated to drive growth due to increasing healthcare spending and a rising incidence of chronic diseases.

Technological Advancements

Advancements in clinical trial technologies, such as virtual trials and personalized medicine, are expected to enhance the efficiency and effectiveness of drug development, including for corticosteroids. This could lead to new formulations or applications of existing corticosteroids.

Key Takeaways

• DECASPRAY, a dexamethasone topical aerosol, was discontinued in 2003 due to reasons other than safety or effectiveness.
• Dexamethasone continues to be studied and used in various clinical contexts, including COVID-19 treatment and postoperative care.
• The global market for corticosteroids and related pharmaceuticals is significant and growing, driven by technological advancements and increasing healthcare needs.
• Emerging markets and advancements in clinical trial technologies are expected to play a crucial role in the future of pharmaceutical development.

FAQs

What was DECASPRAY used for?

DECASPRAY was used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Why was DECASPRAY discontinued?

DECASPRAY was discontinued by Merck & Co., Inc. in 2003 for reasons other than safety or effectiveness[1].

Is dexamethasone still used in clinical practice?

Yes, dexamethasone is still widely used in various clinical contexts, including COVID-19 treatment and postoperative care[5].

What is the current market outlook for corticosteroids?

The market for corticosteroids is expected to grow, driven by increasing healthcare needs and technological advancements in drug development[4].

Are there any new formulations or applications of dexamethasone being developed?

While specific new formulations of DECASPRAY are not being developed, dexamethasone continues to be a subject of research in various therapeutic areas, including COVID-19 and postoperative care[5].

How does the discontinuation of DECASPRAY affect the broader pharmaceutical market?

The discontinuation of DECASPRAY does not significantly impact the broader pharmaceutical market, as dexamethasone remains a widely used and studied corticosteroid in other formulations[1].

Sources

1. Federal Register/Vol. 76, No. 27/Wednesday, February 9, 2011 - In its annual report, Merck notified FDA that DECASPRAY (dexamethasone) Topical Aerosol, 0.04%, was being discontinued.
2. Proprietary Name Review(s) - accessdata.fda.gov - List of proprietary names reviewed by the FDA.
3. NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData estimates on the NSCLC market.
4. Clinical Trials Market Size, Share And Growth Report, 2030 - Grand View Research report on the global clinical trials market.
5. PRIME PubMed | Decaspray journal articles from PubMed - Various clinical studies involving dexamethasone.