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Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR ORAPRED ODT


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All Clinical Trials for Orapred Odt

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00079105 ↗ A Phase II Study VEPEMB In Patients With Hodgkin's Lymphoma Aged ≥ 60 Years Completed Newcastle-upon-Tyne Hospitals NHS Trust Phase 2 2004-01-01 RATIONALE: Drugs used in chemotherapy, such as vinblastine, cyclophosphamide, procarbazine, prednisolone, etoposide, mitoxantrone, and bleomycin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkin's lymphoma.
NCT00798616 ↗ Steroids Helping Albuterol Responders Exclusively Withdrawn University Hospitals Cleveland Medical Center N/A 1969-12-31 The purpose of the study is to determine whether corticosteroids are beneficial to children with bronchiolitis whose breathing gets better after being given a breathing treatment with albuterol.
NCT01211665 ↗ Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS) Terminated Elan Pharmaceuticals Phase 4 2010-09-01 The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.
NCT01211665 ↗ Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS) Terminated Biogen Phase 4 2010-09-01 The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.
NCT01391793 ↗ Corticosteroids for Children With Febrile Urinary Tract Infections Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 3 2011-09-01 In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
NCT01391793 ↗ Corticosteroids for Children With Febrile Urinary Tract Infections Completed Nader Shaikh Phase 3 2011-09-01 In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
NCT01391793 ↗ Corticosteroids for Children With Febrile Urinary Tract Infections Completed University of Pittsburgh Phase 3 2011-09-01 In this study the investigators will determine whether corticosteroids given at the time of urinary tract infection help prevent permanent damage to the kidneys.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Orapred Odt

Condition Name

Condition Name for Orapred Odt
Intervention Trials
Keratoplasty, Lamellar 1
Urticaria 1
Leukoencephalopathy, Progressive Multifocal 1
Wheezes 1
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Condition MeSH

Condition MeSH for Orapred Odt
Intervention Trials
Neoplasms 1
Hodgkin Disease 1
Syndrome 1
Mucositis 1
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Clinical Trial Locations for Orapred Odt

Trials by Country

Trials by Country for Orapred Odt
Location Trials
United States 12
United Kingdom 3
Germany 2
Thailand 1
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Trials by US State

Trials by US State for Orapred Odt
Location Trials
Ohio 2
Nebraska 1
Florida 1
Oregon 1
California 1
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Clinical Trial Progress for Orapred Odt

Clinical Trial Phase

Clinical Trial Phase for Orapred Odt
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Orapred Odt
Clinical Trial Phase Trials
Completed 3
Active, not recruiting 2
Terminated 2
[disabled in preview] 1
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Clinical Trial Sponsors for Orapred Odt

Sponsor Name

Sponsor Name for Orapred Odt
Sponsor Trials
Newcastle-upon-Tyne Hospitals NHS Trust 1
Oregon Health and Science University 1
University Hospitals Cleveland Medical Center 1
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Sponsor Type

Sponsor Type for Orapred Odt
Sponsor Trials
Other 10
Industry 4
NIH 1
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ORAPRED ODT: Clinical Trials, Market Analysis, and Projections

Introduction

ORAPRED ODT (prednisolone sodium phosphate orally disintegrating tablets) is a significant advancement in the treatment of various inflammatory and immunosuppressive conditions. Developed by BioMarin Pharmaceutical Inc., this formulation has been designed to offer a convenient and easy-to-administer alternative to traditional prednisolone formulations.

Clinical Trials and Approval

ORAPRED ODT was submitted for a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and was approved on June 1, 2006[5].

Key Indications

ORAPRED ODT is indicated for a wide range of conditions, including allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases, and organ transplantation. It is also used for the treatment of certain endocrine conditions and the palliation of certain neoplastic conditions[2][4].

Dosage and Administration

The dosage of ORAPRED ODT is individualized based on the severity of the disease and the patient's response. The initial dose can range from 10 to 60 mg (prednisolone base) per day. It is crucial to adjust the dosage in small decrements to maintain the lowest effective dose, and the drug should be withdrawn gradually if discontinued after long-term therapy[2][4].

Market Analysis

Market Position

ORAPRED ODT holds a unique position in the market as the first and only prednisolone oral disintegrating tablet available. This formulation addresses the need for a convenient, taste-masked, and non-refrigerated option for patients requiring corticosteroid therapy[1].

Competitive Landscape

The corticosteroid market is competitive, with various formulations available, including oral solutions, tablets, and injectables. However, ORAPRED ODT's orally disintegrating tablet technology sets it apart, making it particularly appealing for patients who have difficulty swallowing conventional tablets or prefer a more convenient administration method.

Patient Preferences

Patient compliance is a critical factor in the success of any medication. The ease of administration and the convenience of ORAPRED ODT are likely to enhance patient adherence, particularly in pediatric and geriatric populations where swallowing tablets can be challenging.

Market Projections

Growth Potential

Given its unique formulation and the broad range of indications, ORAPRED ODT is expected to continue growing in the market. The demand for convenient and patient-friendly medications is increasing, and ORAPRED ODT is well-positioned to capitalize on this trend.

Market Size

The corticosteroid market is substantial, and ORAPRED ODT's share is expected to grow as more healthcare providers and patients become aware of its benefits. The market size for corticosteroids is projected to increase due to the rising incidence of inflammatory and autoimmune diseases.

Generic Competition

As of the latest updates, there are no generic versions of ORAPRED ODT available. The original approval date and patent status suggest that BioMarin retains exclusivity for this formulation, which will help maintain its market position until generic alternatives become available[5].

Clinical Outcomes and Safety

Efficacy

Clinical trials have demonstrated the efficacy of ORAPRED ODT in managing various inflammatory and immunosuppressive conditions. Its ability to provide rapid relief and maintain therapeutic levels of prednisolone makes it a valuable treatment option[2][4].

Safety Profile

The safety profile of ORAPRED ODT is consistent with other corticosteroids. Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, and behavioral and mood changes. It is essential to monitor patients closely and adjust dosages as necessary to minimize adverse effects[2][4].

Patient Counseling and Education

Administration Instructions

Patients should be instructed not to remove the tablet from the blister pack until just prior to dosing. The tablet can be swallowed whole or allowed to dissolve in the mouth with or without water[4].

Adverse Reaction Management

Patients and healthcare providers should be aware of the potential adverse reactions and take steps to manage them. This includes monitoring for signs of fluid retention, glucose intolerance, and blood pressure changes.

Key Takeaways

  • Unique Formulation: ORAPRED ODT is the first prednisolone oral disintegrating tablet, offering a convenient and easy-to-administer option.
  • Broad Indications: It is indicated for a wide range of inflammatory and immunosuppressive conditions.
  • Market Position: ORAPRED ODT holds a unique position in the market due to its formulation.
  • Growth Potential: The demand for convenient medications is increasing, positioning ORAPRED ODT for continued growth.
  • Safety Profile: The safety profile is consistent with other corticosteroids, requiring close monitoring and dosage adjustments.

FAQs

What is ORAPRED ODT used for?

ORAPRED ODT is used as an anti-inflammatory or immunosuppressive agent for various conditions, including allergic, dermatologic, gastrointestinal, and rheumatologic diseases, among others[2][4].

How is ORAPRED ODT administered?

ORAPRED ODT is administered by placing the orally disintegrating tablet on the tongue, where it can be swallowed whole or allowed to dissolve in the mouth with or without water[4].

What are the common adverse reactions of ORAPRED ODT?

Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, and behavioral and mood changes[2][4].

Is ORAPRED ODT available in generic form?

As of the latest updates, there are no generic versions of ORAPRED ODT available[5].

How is the dosage of ORAPRED ODT determined?

The dosage of ORAPRED ODT is individualized based on the severity of the disease and the patient's response, ranging from 10 to 60 mg (prednisolone base) per day[2][4].

Sources

  1. BioMarin Pharmaceutical Inc. - BioMarin Files New Drug Application for Orapred ODT.
  2. DailyMed - ORAPRED ODT- prednisolone sodium phosphate tablet, orally disintegrating.
  3. Oramed Pharmaceuticals - Oramed Provides Clinical Update with Meaningful Data Expected by Year-End.
  4. FDA - ORAPRED ODT® (prednisolone sodium phosphate orally disintegrating tablets).
  5. Drugs.com - Generic Orapred ODT Availability.

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