CLINICAL TRIALS PROFILE FOR ZOFRAN ODT

505(b)(2) Clinical Trials for ZOFRAN ODT

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01691690 ↗	Analgesic Effect of IV Acetaminophen in Tonsillectomies	Completed	Nationwide Children's Hospital	Phase 2	2012-10-01	Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).

All Clinical Trials for ZOFRAN ODT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006205 ↗	Alcohol Dependency Study: Combining Medication Treatment for Alcoholism	Unknown status	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2005-03-01	The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00006205 ↗	Alcohol Dependency Study: Combining Medication Treatment for Alcoholism	Unknown status	Bankole Johnson	Phase 2	2005-03-01	The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	Roche Pharma AG	Phase 1	2002-11-01	Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
NCT00050167 ↗	Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer	Completed	M.D. Anderson Cancer Center	Phase 1	2002-11-01	Primary Objectives: - Determine the impact of each regimen on the disease free and overall survival of patients with operable breast cancer. - Determine the ability of docetaxel/capecitabine to downstage primary breast cancer when administered in the neoadjuvant setting when compared with weekly paclitaxel. - Determine the ability of each regimen to enhance breast conservation therapy when administered in the neoadjuvant setting. (See protocol text for additional objectives and details).
NCT00027079 ↗	Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2001-09-01	This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.
NCT00000443 ↗	Ondansetron Treatment for Alcoholism	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	1969-12-31	The purpose of this study is to: a) evaluate the effectiveness of ondansetron (Zofran) in the treatment of alcohol dependent patients; b) investigate whether early versus late onset alcoholism predicts treatment outcome; and c) determine whether the early and late onset groups respond differently to treatment. Individuals will be "typed" into early onset and late onset alcoholism groups. Individuals will be randomly assigned to a 12-week outpatient treatment program.

Clinical Trial Conditions for ZOFRAN ODT

Condition Name

Condition Name for ZOFRAN ODT
Intervention	Trials
Nausea	18
Healthy	16
Vomiting	15
Postoperative Nausea and Vomiting	13

Condition MeSH

Condition MeSH for ZOFRAN ODT
Intervention	Trials
Vomiting	57
Nausea	49
Postoperative Nausea and Vomiting	28
Pain, Postoperative	10

Clinical Trial Locations for ZOFRAN ODT

Trials by Country

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Trials by Country for ZOFRAN ODT
Location	Trials
United States	146
Canada	32
Germany	11
India	9
Italy	7

Trials by US State

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−

Trials by US State for ZOFRAN ODT
Location	Trials
Texas	27
New York	13
California	12
Florida	8
Virginia	7

Clinical Trial Progress for ZOFRAN ODT

Clinical Trial Phase

Clinical Trial Phase for ZOFRAN ODT
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	14
Phase 2/Phase 3	5

Clinical Trial Status

Clinical Trial Status for ZOFRAN ODT
Clinical Trial Phase	Trials
Completed	115
Recruiting	15
Terminated	15

Clinical Trial Sponsors for ZOFRAN ODT

Sponsor Name

Sponsor Name for ZOFRAN ODT
Sponsor	Trials
M.D. Anderson Cancer Center	11
Merck Sharp & Dohme Corp.	11
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	7

Sponsor Type

Sponsor Type for ZOFRAN ODT
Sponsor	Trials
Other	198
Industry	64
NIH	18

Zofran ODT: Clinical Trials, Market Analysis, and Projections

Introduction to Zofran ODT

Zofran ODT, or ondansetron orally disintegrating tablets, is a medication primarily used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative procedures. Here, we will delve into the latest clinical trials updates, market analysis, and projections for this drug.

Clinical Trials and Safety Updates

QT Interval Prolongation Study

A significant clinical study update came in 2012 when the FDA informed healthcare professionals about the potential for ondansetron to prolong the QT interval, which could lead to a fatal heart rhythm known as Torsades de Pointes. This study led to changes in the drug label, removing the 32 mg single intravenous dose due to its association with QT prolongation. Instead, the recommended dose was adjusted to 0.15 mg/kg administered every 4 hours for three doses, with no single intravenous dose exceeding 16 mg[1].

FDA Determination on Safety and Effectiveness

In a recent notice, the FDA determined that Zofran ODT (ondansetron) orally disintegrating tablets, 4 mg and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination was made after reviewing citizen petitions and evaluating relevant literature and data for postmarketing adverse events[4].

Market Analysis

Global Market Size and Growth

The global ondansetron hydrochloride injection market, which includes Zofran ODT, is projected to see significant growth. The market size is estimated to grow from 2019 to 2031, with forecasts indicating a substantial increase in revenue. The base year for these calculations is 2023, and the forecasted data extends from 2025 to 2031[2].

Segmentation and Regional Analysis

The ondansetron market is segmented by type, application, and distribution channels. North America currently leads the global market, with a significant share attributed to Zofran ODT. The market is further segmented into regions such as Europe, Asia Pacific, Middle East & Africa, and Latin America, each providing insights into revenue share and current trends[2][5].

Market Drivers and Restraints

• Drivers: The rising prevalence of gastrointestinal disorders, growing awareness of antiemetic drugs, and higher prescription rates by healthcare professionals for chemotherapy-induced nausea and vomiting are key drivers of the market[5].
• Restraints: Supply chain disruptions, generic drug competition, and intellectual property challenges are significant restraints affecting the market[5].

Market Opportunities and Challenges

Opportunities

• Growing Demand: Capturing the growing demand for ondansetron in managing chemotherapy-induced nausea and vomiting presents a significant opportunity.
• Emerging Markets: Targeting opportunities in enhancing distribution channels in emerging markets can expand the market reach.
• New Formulations: Exploring new formulation techniques to increase ondansetron's bioavailability and efficacy is another area of opportunity[5].

Challenges

• Regulatory Changes: Adapting to regulatory changes and compliance is a major challenge.
• R&D Expenditure: Maintaining innovation while managing increasing R&D expenditure is crucial.
• Liberalizing Healthcare Policies: Navigating the dual impact of liberalizing healthcare policies on market reach and penetration is a significant challenge[5].

Competitive Analysis

Porter’s Five Forces Analysis

This analysis helps businesses understand their competitive position and the power dynamics within the market. It identifies whether new products or companies have the potential to be profitable and informs strategies to leverage strengths and address weaknesses[5].

FPNV Positioning Matrix

The FPNV positioning matrix evaluates vendors based on business strategy and product satisfaction, categorizing them into distinct quadrants such as Forefront, Pathfinder, Niche, or Vital. This matrix aids in making well-informed decisions aligned with market requirements[5].

Market Projections

Forecasted Growth

The ondansetron oral drugs market, including Zofran ODT, is expected to grow significantly from 2025 to 2030. The market size is projected to increase due to the rising prevalence of gastrointestinal disorders and the growing awareness of antiemetic drugs[5].

Regional Growth

North America is expected to maintain its leadership in the global market, with other regions such as Europe and Asia Pacific also showing substantial growth. The market analysis includes detailed data from key industry players and assesses potential growth prospects in emerging markets[2][5].

Key Takeaways

• Clinical Safety: Zofran ODT has undergone significant clinical trials, leading to adjustments in dosing to ensure safety.
• Market Growth: The global market for ondansetron hydrochloride injection, including Zofran ODT, is projected to grow substantially.
• Regional Leadership: North America leads the market, with opportunities for growth in emerging regions.
• Challenges and Opportunities: The market faces challenges such as regulatory changes and generic competition but also presents opportunities in new formulations and distribution channels.

Frequently Asked Questions (FAQs)

1. What is the primary use of Zofran ODT?

Zofran ODT is primarily used to prevent nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative procedures.

2. What changes were made to the Zofran ODT label due to clinical trials?

The label was updated to remove the 32 mg single intravenous dose due to QT interval prolongation concerns, recommending instead a dose of 0.15 mg/kg administered every 4 hours for three doses, with no single intravenous dose exceeding 16 mg[1].

3. What regions are leading the global ondansetron market?

North America currently leads the global market, followed by Europe, Asia Pacific, Middle East & Africa, and Latin America[2][5].

4. What are the key drivers of the ondansetron market?

The rising prevalence of gastrointestinal disorders, growing awareness of antiemetic drugs, and higher prescription rates by healthcare professionals are key drivers[5].

5. What challenges does the ondansetron market face?

The market faces challenges such as supply chain disruptions, generic drug competition, and adapting to regulatory changes[5].

Cited Sources:

1. FDA Drug Safety Communication: New Information Regarding QT Prolongation with Ondansetron (Zofran)[1]
2. Global Ondansetron Hydrochloride Injection Market Report 2024[2]
3. Advanced ODT Technologies for Drug Development - CMIC Group[3]
4. Federal Register: Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness[4]
5. Ondansetron Oral Drugs Market Size & Share 2025-2030[5]