CLINICAL TRIALS PROFILE FOR ENTOCORT EC

All Clinical Trials for Entocort Ec

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00135408 ↗	A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide	Completed	Medarex	Phase 2	2005-12-01	The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
NCT00135408 ↗	A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide	Completed	Bristol-Myers Squibb	Phase 2	2005-12-01	The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.
NCT00343642 ↗	Dietary Treatment of Crohn's Disease	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 1/Phase 2	2006-09-01	Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.
NCT00343642 ↗	Dietary Treatment of Crohn's Disease	Completed	Rush University Medical Center	Phase 1/Phase 2	2006-09-01	Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.
NCT00587119 ↗	Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis	Withdrawn	Mayo Clinic	N/A	2007-12-01	The purpose of the study is to find out the effects Budesonide, 9 mg daily for one year, has on patients with Primary Biliary Cirrhosis with features of autoimmune hepatitis.
NCT00679380 ↗	(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis	Completed	Cosmo Technologies Ltd	Phase 3	2008-06-01	This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.
NCT00679380 ↗	(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis	Completed	Bausch Health Americas, Inc.	Phase 3	2008-06-01	This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period. After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.

Clinical Trial Conditions for Entocort Ec

Condition Name

Condition Name for Entocort Ec
Intervention	Trials
Crohn's Disease	4
Inflammatory Bowel Disease	2
Ulcerative Colitis	2
Chronic Obstructive Lung Disease	1

Condition MeSH

Condition MeSH for Entocort Ec
Intervention	Trials
Crohn Disease	4
Colitis	3
Colitis, Ulcerative	2
Inflammatory Bowel Diseases	2

Clinical Trial Locations for Entocort Ec

Trials by Country

Trials by Country for Entocort Ec
Location	Trials
United States	26
Canada	5
Poland	5
Italy	4
United Kingdom	3

Trials by US State

Trials by US State for Entocort Ec
Location	Trials
New York	4
Illinois	3
Georgia	3
New Jersey	2
Minnesota	2

Clinical Trial Progress for Entocort Ec

Clinical Trial Phase

Clinical Trial Phase for Entocort Ec
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	4

Clinical Trial Status

Clinical Trial Status for Entocort Ec
Clinical Trial Phase	Trials
Completed	5
Terminated	4
Not yet recruiting	2

Clinical Trial Sponsors for Entocort Ec

Sponsor Name

Sponsor Name for Entocort Ec
Sponsor	Trials
Perrigo Company	2
Pooja Budhiraja, MD	1
Cosmo Technologies Ltd	1

Sponsor Type

Sponsor Type for Entocort Ec
Sponsor	Trials
Industry	9
Other	8
NIH	3

Entocort EC: Clinical Trials, Market Analysis, and Projections

Introduction

Entocort EC, containing the active ingredient budesonide, is a synthetic corticosteroid used for the treatment and maintenance of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials Overview

Treatment of Mild to Moderate Active Crohn’s Disease

Several clinical trials have been conducted to evaluate the efficacy and safety of Entocort EC. Here are some key findings:

• Studies 1-5: These studies compared the efficacy of Entocort EC against placebos and other treatments. For instance, Study 1 showed that Entocort EC 9 mg once daily resulted in a significantly higher clinical improvement rate at Week 8 compared to the comparator[1][5].
• Dose Efficacy: Study 2 involved 258 patients and tested graded doses of Entocort EC (1.5 mg bid, 4.5 mg bid, or 7.5 mg bid) versus placebo. The 9 mg per day dose was statistically different from placebo, while higher doses did not show additional benefits[1][5].
• Comparison with Prednisolone: Studies 4 and 5 compared Entocort EC with oral prednisolone. Both studies showed that Entocort EC had similar clinical improvement rates to prednisolone but with a higher proportion of patients maintaining normal plasma cortisol levels[1].

Maintenance of Clinical Remission

Four double-blind, placebo-controlled, 12-month trials evaluated the efficacy of Entocort EC for maintaining clinical remission. These trials involved 380 patients treated with 3 mg or 6 mg of Entocort EC once daily.

• Time to Relapse: The median time to relapse was significantly longer for patients taking Entocort EC 6 mg/day (268 days) compared to those on placebo (154 days)[1].
• Symptom Control: Entocort EC 6 mg/day reduced the proportion of patients with loss of symptom control relative to placebo at 3 months[1].

Safety and Adverse Reactions

Common Adverse Reactions

Clinical trials identified several common adverse reactions associated with Entocort EC, including:

• Short-term Treatment: Diarrhea, headache, nausea, and abdominal pain were among the most common adverse reactions in short-term trials[2][5].
• Long-term Maintenance: In long-term trials, additional adverse reactions included sinusitis, viral infections, and arthralgia[2].

Laboratory Test Findings

Potentially clinically significant laboratory changes included hypokalemia, leukocytosis, anemia, and increased erythrocyte sedimentation rate and C-reactive protein[2][5].

Market Analysis

Sales and Growth

Entocort EC has seen significant growth in sales, particularly after Prometheus Labs acquired the rights and implemented a diagnostic-driven marketing strategy.

• Sales Increase: Since Prometheus started marketing Entocort EC, sales in the US have grown by 59% annually, reaching $125 million annually[4].
• Pricing Strategy: The average wholesale price for Entocort EC increased by 66% immediately after Prometheus acquired the rights and by 10% each year thereafter, reflecting the increased value to patients and physicians[4].

Market Opportunities

The integration of diagnostic tools has been crucial in identifying patients who would benefit from Entocort EC, thereby enhancing its efficacy and market value.

• Diagnostic-Driven Marketing: Prometheus Labs’ approach of recruiting a specialty sales force to market both the diagnostic and the drug helped in targeting the right patient subset, leading to improved sales and pricing[4].

Projections and Future Outlook

Market Potential

Given its efficacy in treating and maintaining remission in Crohn’s disease, Entocort EC is expected to continue its market growth.

• Patient Population: With a growing number of patients diagnosed with Crohn’s disease, the demand for effective treatments like Entocort EC is likely to increase[3].
• Competitive Landscape: While there are other treatments available, Entocort EC’s unique formulation and the diagnostic-driven marketing strategy give it a competitive edge[4].

Regulatory and Developmental Aspects

Budesonide, the active ingredient in Entocort EC, is also under development for other indications, such as acute intestinal graft versus host disease (GVHD) after hematopoietic stem cell transplantation. This expands the potential market for budesonide-based treatments[3].

Key Takeaways

• Clinical Efficacy: Entocort EC has demonstrated significant efficacy in treating and maintaining remission in mild to moderate Crohn’s disease.
• Safety Profile: The drug has a manageable safety profile, with common adverse reactions that are generally mild.
• Market Growth: Strategic marketing and the integration of diagnostic tools have driven significant sales growth for Entocort EC.
• Future Outlook: The drug is expected to continue its market growth due to its efficacy and the increasing demand for Crohn’s disease treatments.

FAQs

What is Entocort EC used for?

Entocort EC is used for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon, and for the maintenance of clinical remission of mild to moderate Crohn’s disease for up to 3 months in adults[1][2].

What are the common adverse reactions associated with Entocort EC?

Common adverse reactions include diarrhea, headache, nausea, abdominal pain, sinusitis, viral infections, and arthralgia[2][5].

How has the sales of Entocort EC been impacted by Prometheus Labs?

Prometheus Labs’ diagnostic-driven marketing strategy led to a 59% annual growth in sales in the US, reaching $125 million annually, and a significant increase in the average wholesale price[4].

Is Entocort EC approved for other indications?

Budesonide, the active ingredient in Entocort EC, is under development for the treatment of acute intestinal graft versus host disease (GVHD) after hematopoietic stem cell transplantation[3].

What is the dosage of Entocort EC for treating Crohn’s disease?

The typical dosage for treating active Crohn’s disease is 9 mg once daily, and for maintaining clinical remission, it is 6 mg once daily[1][2].

Sources

1. Entocort EC - accessdata.fda.gov
2. Entocort EC (Budesonide): Side Effects, Uses, Dosage ... - RxList
3. Net Present Value Model: Entocort - GlobalData
4. Overlooked Opportunities - Pharmaceutical Executive
5. Entocort EC: Package Insert / Prescribing Information - Drugs.com

Last updated: 2025-01-07