CLINICAL TRIALS PROFILE FOR ORAPRED

All Clinical Trials for Orapred

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NCT00798616 ↗	Steroids Helping Albuterol Responders Exclusively	Withdrawn	University Hospitals Cleveland Medical Center	N/A	1969-12-31	The purpose of the study is to determine whether corticosteroids are beneficial to children with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.

Clinical Trial Conditions for Orapred

Condition Name

Condition Name for Orapred
Intervention	Trials
Transplantation, Cornea	1
Immune Reconstitution Inflammatory Syndrome	1
Transplantation, Corneal	1
Keratoplasty	1

Condition MeSH

Condition MeSH for Orapred
Intervention	Trials
Syndrome	1
Mucositis	1
Leukoencephalopathy, Progressive Multifocal	1
Breast Neoplasms	1

Clinical Trial Locations for Orapred

Trials by Country

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

Trials by US State

Trials by US State for Orapred
Location	Trials
Ohio	2
Florida	1
Oregon	1
California	1
Texas	1

Clinical Trial Progress for Orapred

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Orapred
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Active, not recruiting	2

Clinical Trial Sponsors for Orapred

Sponsor Name

Sponsor Name for Orapred
Sponsor	Trials
Oregon Health and Science University	1
University Hospitals Cleveland Medical Center	1
Winston Chamberlain, MD, PhD	1

Sponsor Type

Sponsor Type for Orapred
Sponsor	Trials
Other	10
Industry	4
NIH	1

Orapred: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Orapred, a formulation of prednisolone, has been a significant player in the treatment of various inflammatory conditions, particularly in pediatric patients. Developed and marketed by BioMarin Pharmaceutical Inc., Orapred has undergone several transformations and expansions. Here, we will delve into the clinical trials, market analysis, and future projections for Orapred.

Clinical Trials and Development

Original Formulation

Orapred, initially launched in 2001, is an oral solution of prednisolone sodium phosphate. It was designed to treat acute exacerbations of asthma in children, as well as other inflammatory and serious conditions. The original formulation incorporated a patent-protected taste-masking technology, which significantly improved treatment compliance by reducing the bitter taste associated with prednisolone[2].

New Formulations

BioMarin has continued to innovate with new formulations of Orapred. One notable development is Orapred ODT (orally disintegrating tablets), which was submitted for FDA approval in 2005. This formulation is designed to be convenient and easy to administer, making it suitable for individuals of all ages[1].

Another significant development includes a non-refrigerated formulation, "Orapred 2," and a quick-dissolve tablet formulation. These new products aimed to enhance convenience and expand the market to older pediatric patients. The quick-dissolve tablet, in particular, utilized proprietary technology to address the needs of older children[2].

Market Analysis

Market Performance

Since its launch, Orapred has demonstrated strong market performance. By 2003, it had generated more than 2.4 million prescriptions, capturing over 50% of the share of prescriptions for liquid oral prednisolone. This success was attributed to its ability to improve treatment compliance and symptomatic relief, especially in children under the age of six who often struggle with the bitter taste of traditional prednisolone formulations[2].

Financial Impact

The acquisition of the Orapred product line from Medicis Pharmaceutical Corporation was a strategic move for BioMarin. It was expected to generate significant cash flow and accelerate BioMarin's goal of reaching profitability. Net sales of Orapred were projected to be around $42 million for the 12 months ending December 31, 2004, making the transaction accretive to BioMarin immediately upon closing[2].

Market Expansion

BioMarin planned to expand the Orapred product line into new markets outside of the U.S. in the second half of 2005 or early 2006. This expansion, coupled with the introduction of new formulations, was expected to increase sales and further solidify Orapred's market position[2].

Projections and Future Outlook

Continued Growth

The introduction of new formulations and the expansion into international markets were expected to drive continued growth for Orapred. The potential increase in sales from organic product growth, line extensions, and new market entries positioned Orapred as a key contributor to BioMarin's financial health and its journey towards profitability[2].

Competitive Advantage

Orapred's unique taste-masking technology and the convenience of its new formulations provided a competitive advantage. This advantage, combined with the growing number of asthma patients and the increasing need for effective and compliant treatments, suggested a bright future for Orapred in the pediatric asthma market[2].

Regulatory Approvals and Timelines

FDA Approvals

The submission of the New Drug Application (NDA) for Orapred ODT in 2005 marked a significant milestone. Pending regulatory approval, BioMarin expected to have Orapred ODT on the market by mid-2006. This timeline was crucial for expanding the product's reach and enhancing its market position[1].

Key Takeaways

• Clinical Trials and Development: Orapred has evolved through various formulations, including an orally disintegrating tablet and a non-refrigerated version, to improve convenience and compliance.
• Market Performance: Orapred has shown strong market performance, capturing a significant share of prescriptions for liquid oral prednisolone and generating substantial revenue.
• Financial Impact: The acquisition of Orapred by BioMarin was financially beneficial, contributing to the company's path towards profitability.
• Market Expansion: Plans for international market entry and the introduction of new formulations were expected to drive further growth.
• Future Outlook: Orapred is poised for continued growth due to its competitive advantages, expanding market, and the increasing need for effective asthma treatments.

FAQs

What is Orapred used for?

Orapred is primarily used to treat acute exacerbations of asthma in children, as well as other inflammatory and serious conditions such as arthritis and cancer.

What makes Orapred unique?

Orapred incorporates a patent-protected taste-masking technology that reduces the bitter taste associated with prednisolone, improving treatment compliance, especially in young children.

What new formulations of Orapred have been developed?

New formulations include Orapred ODT (orally disintegrating tablets) and a non-refrigerated formulation, as well as a quick-dissolve tablet formulation using proprietary technology.

How has Orapred performed in the market?

Orapred has captured over 50% of the share of prescriptions for liquid oral prednisolone and generated significant revenue, contributing to BioMarin's financial health.

What are the future projections for Orapred?

Orapred is expected to continue growing through new market entries, line extensions, and the introduction of new formulations, solidifying its position in the pediatric asthma market.

Sources

1. BioMarin Files New Drug Application for Orapred ODT - BioMarin Pharmaceutical Inc.
2. BioMarin to Obtain Profitable Pediatric Business from Medicis - BioMarin Pharmaceutical Inc.
3. Oramed Provides Clinical Update with Meaningful Data Expected by Year-End - PR Newswire
4. Clinical Trials Appendix - AstraZeneca - AstraZeneca
5. Oramed Pharmaceuticals (ORMP) Stock Price, News & Analysis - MarketBeat