CLINICAL TRIALS PROFILE FOR ULTRAM

505(b)(2) Clinical Trials for ULTRAM

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	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Bayer	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	University of Pennsylvania	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.
OTC	NCT04694300 ↗	OTC Naproxen and Acetaminophen Anti-Inflammatory Action in Dental Implant Patients	Recruiting	Hersh, Elliot V., DMD, MS, PhD	Phase 4	2021-02-07	This double-blind pilot study will evaluate the anti-inflammatory and analgesic effects of an over-the-counter (OTC) regimen of naproxen sodium versus acetaminophen in patients receiving one or two (adjacent) dental implants. It will also confirm that naproxen sodium in the OTC dosage range is a good alternative to immediate-release opioid formulations, which are subject to misuse, abuse and diversion in this patient population.

All Clinical Trials for ULTRAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00290901 ↗	Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.	Completed	Pfizer	Phase 4	2006-03-01	This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00290901 ↗	Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	Phase 4	2006-03-01	This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.
NCT00236483 ↗	A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery	Completed	PriCara, Unit of Ortho-McNeil, Inc.	Phase 4	2002-11-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.
NCT00236483 ↗	A Comparison of the Effectiveness and Safety of ULTRACET® (Tramadol Hydrochloride/Acetaminophen) Versus ULTRAM® (Tramadol Hydrochloride) Versus Placebo in Patients With Pain After Oral Surgery	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Phase 4	2002-11-01	The purpose of this study is to explore the pain-relieving effects and safety of two analgesic treatment regimens as compared to placebo in patients experiencing pain after oral surgery. Tramadol hydrochloride/acetaminophen is approved to treat acute pain. This study will evaluate the effectiveness and safety of tramadol hydrochloride/acetaminophen compared with tramadol hydrochloride alone compared with placebo as a pain medication in the treatment of pain following oral surgery.

Clinical Trial Conditions for ULTRAM

Condition Name

Condition Name for ULTRAM
Intervention	Trials
Pain	6
Opioid Addiction	2
Shoulder Pain	2
Healthy	2

Condition MeSH

Condition MeSH for ULTRAM
Intervention	Trials
Opioid-Related Disorders	3
Pain, Postoperative	2
Shoulder Pain	2
Neoplasms	1

Clinical Trial Locations for ULTRAM

Trials by Country

+

−

Trials by Country for ULTRAM
Location	Trials
United States	37
Puerto Rico	1
Denmark	1

Trials by US State

+

−

Trials by US State for ULTRAM
Location	Trials
Maryland	4
Illinois	3
Utah	2
Minnesota	2
Pennsylvania	2

Clinical Trial Progress for ULTRAM

Clinical Trial Phase

Clinical Trial Phase for ULTRAM
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ULTRAM
Clinical Trial Phase	Trials
Completed	13
Recruiting	4
Unknown status	2

Clinical Trial Sponsors for ULTRAM

Sponsor Name

Sponsor Name for ULTRAM
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	4
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	3
Children's Hospitals and Clinics of Minnesota	2

Sponsor Type

Sponsor Type for ULTRAM
Sponsor	Trials
Other	16
Industry	13
NIH	4

Ultram (Tramadol): Clinical Trials, Market Analysis, and Projections

Introduction

Ultram, known generically as tramadol, is a centrally-acting opioid agonist and serotonin/norepinephrine reuptake inhibitor (SNRI) used for managing moderate to severe pain in adults. This article provides an update on the clinical trials, market analysis, and projections for tramadol.

Clinical Trials and Efficacy

Recent Clinical Studies

Clinical trials for tramadol, particularly for new formulations and indications, have been ongoing. For instance, the FDA approved a new drug application (NDA) for tramadol IV, which relied on the safety and efficacy findings of Ultram (tramadol hydrochloride). This NDA was supported by two adequate and well-controlled Phase 3 trials (Studies 102 and 103) that demonstrated a statistically significant difference between tramadol IV 50 mg and placebo for pain intensity and time to meaningful pain relief[4].

Combination Therapies

Another significant development is the creation of combination therapies involving tramadol. For example, E-58425, a fixed-dose combination of celecoxib and tramadol hydrochloride, has been developed for managing acute pain in adults. Clinical studies for E-58425 did not reveal any novel risks compared to individual components, and the most common adverse events were similar to those reported with tramadol, including nausea, vomiting, somnolence, and dizziness[1].

Safety and Adverse Events

Tramadol, as an opioid, carries risks such as respiratory depression, sedation, and the potential for opioid use disorder. However, clinical studies have shown that the drug characteristics of new formulations like E-58425 do not increase or decrease these risks relative to other tramadol products[1].

Market Analysis

Global Market Size and Growth

The global tramadol market was valued at USD 4.24 billion in 2023 and is expected to grow at a CAGR of 6.86% from 2024 to 2030, reaching nearly USD 6.75 billion by 2030[2]. Another report indicates that the market stood at USD 2.11 billion in 2023 and is projected to reach USD 3.50 billion by 2032, with a CAGR of 5.8% during the forecast period[3].

Market Segmentation

The tramadol market is segmented based on dosage form, route of administration, and region. The tablet segment holds the largest market share due to its high efficacy, ease of manufacturing, convenience of dosing, and cost-effectiveness. Tramadol tablets are available in immediate-release, extended-release, and sustained-release formulations, which contribute to their widespread acceptance[2].

Regional Analysis

North America dominates the global tramadol market, driven by the rising prevalence of pain conditions, a large patient population, and a well-established healthcare infrastructure. The region's market stood at USD 1.05 billion in 2023 and is expected to grow substantially during the forecast period[2][3].

Market Drivers

Increasing Regulatory Approvals

The market growth is driven by the rise in regulatory approvals for new indications of tramadol. Each new approval expands the drug's utility, tapping into unmet medical needs and diversifying its applications. This includes approvals for managing neuropathic pain, post-surgical recovery, and other pain-related conditions[3].

Research and Development

Continued investments in research and development to improve tramadol's safety profile, efficacy, and patient outcomes are key drivers. New extended-release formulations and combination therapies with non-opioid analgesics or adjuvants aim to enhance pain management while reducing opioid-related side effects[2].

Prevalence of Chronic Diseases

The increasing number of chronic disease cases and surgeries globally, particularly among the aging population, drives the demand for tramadol. The drug is used to manage severe pain associated with conditions such as neuropathic pain, dental pain, and cancer, making it a preferred choice for long-term opioid treatment when alternative treatments are inadequate[3].

Market Challenges

Adverse Events and Abuse Potential

Despite its efficacy, tramadol is associated with adverse events such as respiratory depression, sedation, and the potential for opioid use disorder. These risks necessitate the implementation of risk management strategies, including the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits outweigh the risks[1].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the tramadol market, with a decrease in patient visits and surgeries leading to reduced prescriptions. However, the market rebounded to pre-pandemic levels in 2022 and is projected to experience moderate growth during the forecast period[3].

Key Players

Major players in the tramadol market include Grünenthal, Zydus Group, and GSK plc. These companies are involved in various research and development initiatives to enhance the safety and efficacy of tramadol formulations[3].

Future Projections

Market Growth

The tramadol market is expected to grow significantly, driven by increasing regulatory approvals, research and development initiatives, and the rising prevalence of chronic diseases. The market's CAGR is projected to be around 5.8% to 6.86% during the forecast period, indicating a robust growth trajectory[2][3].

New Therapeutic Indications

Exploring new therapeutic indications, such as neuropathic pain and post-surgical recovery, is expected to broaden tramadol's market reach. Personalized medicine approaches, including genetic testing to optimize tramadol dosage and identify patients at higher risk of adverse effects, will also contribute to market growth[2].

Key Takeaways

• Clinical Trials: Recent clinical trials, including those for tramadol IV and combination therapies like E-58425, have demonstrated the efficacy and safety of tramadol.
• Market Size: The global tramadol market is valued at billions of dollars and is expected to grow at a CAGR of 5.8% to 6.86% during the forecast period.
• Market Drivers: Regulatory approvals, research and development, and the prevalence of chronic diseases are key drivers of market growth.
• Challenges: Adverse events and the potential for opioid use disorder remain significant challenges.
• Future Projections: The market is expected to grow significantly, driven by new therapeutic indications and personalized medicine approaches.

FAQs

What is the current market size of the global tramadol market?

The global tramadol market was valued at USD 4.24 billion in 2023 and is expected to grow to nearly USD 6.75 billion by 2030[2].

What are the main drivers of the tramadol market growth?

The main drivers include increasing regulatory approvals for new indications, research and development initiatives, and the rising prevalence of chronic diseases[2][3].

What are the common adverse events associated with tramadol?

Common adverse events include nausea, vomiting, somnolence, and dizziness. Serious risks include respiratory depression, sedation, and the potential for opioid use disorder[1].

Which region dominates the global tramadol market?

North America dominates the global tramadol market due to its large patient population and well-established healthcare infrastructure[2][3].

What are the future projections for the tramadol market?

The market is expected to grow significantly, driven by new therapeutic indications, research and development initiatives, and personalized medicine approaches, with a projected CAGR of 5.8% to 6.86% during the forecast period[2][3].

Sources

1. FDA: 213426Orig1s000 - accessdata.fda.gov
2. Stellar Market Research: Tramadol Market: Global Industry Analysis and Forecast (2024-2030)
3. Fortune Business Insights: Tramadol Market Size, Share, Forecast | Growth Report [2032]
4. FDA: Tramadol Hydrochloride 50 mg/mL injection (tramadol IV) - FDA
5. DrugBank: Tramadol: Uses, Interactions, Mechanism of Action | DrugBank Online