CLINICAL TRIALS PROFILE FOR MS CONTIN

All Clinical Trials for MS CONTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003687 ↗	Treatment for Chronic Pain in Patients With Advanced Cancer	Completed	NCIC Clinical Trials Group	Phase 3	1998-06-11	RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain. PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.
NCT00009672 ↗	Pain Treatment for Sciatica	Completed	National Institute of Dental and Craniofacial Research (NIDCR)	Phase 2	2001-01-30	This study will test the effectiveness of two drugs-nortriptyline and MS Contin (a type of morphine)-to treat pain caused by lumbar radiculopathy, or sciatica. Sciatica results from damage to the lumbar nerve roots, typically causing back pain and sharp, shooting pain down one or both legs. Although sciatica is common, there are no good treatments for it. Tricyclic antidepressants, such as nortriptyline, and opioids, such as morphine, have been effective in treating other kinds of pain from nerve damage. Patients between 18 and 65 years of age who have had sciatica pain daily for at least 3 months may be eligible for this study. Participants will provide a medical history and occupational and other social information. They will undergo a neurological examination, routine blood tests and an electrocardiogram and will fill out three questionnaires providing information on daily functioning and psychological well-being. This "cross-over" study consists of several parts, including a baseline study and four different treatment regimens. During each part, patients keep a daily log in which they rate their pain, record other procedures they undergo, such as injections and manipulations, and record medication side effects. In the first week of the study, patients remain on their current medications. Any antidepressants or opioids are stopped gradually before starting the drug trials. After the first week, patients go through the following four drug trials in random order: 1. Nortriptyline and inert placebo-Patients take nortriptyline in doses ranging from 25 mg. to 100 mg. and an inert placebo for morphine. (An inert placebo is a dummy pill; it looks like the test drug but has no active ingredient.) 2. MS Contin (morphine) and inert placebo-Patients take MS Contin in doses ranging from 30 mg. to 90 mg. and an inert placebo for nortriptyline. 3. Nortriptyline and MS Contin-Patients take MS Contin and nortriptyline in the same dose ranges as for each drug alone. 4. Active placebo and inactive placebo-Patients take an active placebo-in this case benztropine-and an inert placebo. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug-in this case, slight sleepiness or dry mouth. Benztropine is given at one-third the recommended dosage. For each drug regimen, the medication dose is increased gradually over 5 weeks until the maximum tolerated dose is reached. At the end of each regimen, patients are taken off the study drugs over a 12-day tapering period and are off drugs completely for another 2 days. Patients are seen by a doctor or nurse at the 7-week point in each study period. After all the drug trials are finished, patients repeat the questionnaires they filled out at the beginning of the study. Patients and their doctors will be informed of the medications that were effective in each individual's care.
NCT00288769 ↗	Oral Vitamin B12 as Potential Treatment of Recurrent Aphthous Stomatitis	Completed	Soroka University Medical Center	N/A	2006-03-01	Background: Recurrent aphthous stomatitis is a common phenomenon in Primary Medicine.Frequency of the phenomenon can be as high as 25% of the general population and the recurrence of the problem can be up to 50%.Different approaches for treatment are described: treatment with various natural vitamins , local ointments , disinfectant agents for local treatment , local antibiotic ointments , NSAID, local cortisone-steroids , and even medication on the basis of immune-depressants of the immune system and systematic steroids . Methods: A double-blind study of daily administration of sublingual Vitamin B12 tablets manufactured by Solgar (each tablet containing 1000 mcg. of Vitamin B12) opposed to placebo tablets. Purpose of the research: To investigate the effect of Vitamin B12 on the frequency of recurrent canker sores of the mouth (RAS). Study hypothesis: Treatment with vitamin B12 will reduce the recurrence rate and will diminish the symptomatology of RAS episodes.
NCT00737737 ↗	Hormone Function in Men Treated for Pain With Opioids or Placebo	Completed	National Institute of Nursing Research (NINR)	Phase 4	2008-08-01	This study will examine hormone function in men with osteoarthritis pain and how it is affected by opioid medication (such as Percocet, Vicodin, MS Contin and morphine) versus placebo. Men between 30 and 65 years of age who have had moderate to severe osteoarthritis joint pain at least 5 days a week over the past 3 months may be eligible for this study. Candidates are screened with a physical examination, x-rays, laboratory and other tests, and questionnaires about pain, mood and medical health. They are given a pain diary to complete for 2 weeks. Participants are admitted to the hospital for two 12 hour overnight stays, during each of which they provide a 24-hour urine collection and have a small blood sample drawn every 20 minutes for 12 hours (from 8:00 p.m. to 8:00 a.m.) through a catheter that remains in place in a vein. Blood pressure and pulse are monitored during this time. After the catheter is removed, subjects complete questionnaires about their pain, mood and activity. For the several weeks between the two hospitalizations, subjects take either an opioid medication or placebo, or standard medication such as motrin and naprosyn, according to random assignment to one of the three groups. All participants will be allowed to take anti-inflammatory medications and acetaminophen during this time as needed, but no other pain medications or treatments. They are monitored two or three times a week by telephone and complete a pain diary. After the second hospitalization, subjects are tapered off the study medication. After 2 to 4 weeks of stopping medication, they return for a final outpatient visit to review pain or other medical problems and to have blood drawn.
NCT01665209 ↗	Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions	Completed	Ranbaxy Inc.	Phase 1	2006-10-01	The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
NCT01665222 ↗	Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fasting Conditions	Completed	Ranbaxy Inc.	Phase 1	2006-10-01	The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.

Clinical Trial Conditions for MS CONTIN

Condition Name

Condition Name for MS CONTIN
Intervention	Trials
Healthy	2
Sciatica	1
Small Intestine Cancer	1
Leukemia	1

Condition MeSH

Condition MeSH for MS CONTIN
Intervention	Trials
Myeloproliferative Disorders	1
Radiculopathy	1
Critical Illness	1
Myelodysplastic Syndromes	1

Clinical Trial Locations for MS CONTIN

Trials by Country

Trials by Country for MS CONTIN
Location	Trials
Canada	4
United States	2
Israel	1
Austria	1

Trials by US State

Trials by US State for MS CONTIN
Location	Trials
Maryland	2

Clinical Trial Progress for MS CONTIN

Clinical Trial Phase

Clinical Trial Phase for MS CONTIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for MS CONTIN
Clinical Trial Phase	Trials
Completed	7

Clinical Trial Sponsors for MS CONTIN

Sponsor Name

Sponsor Name for MS CONTIN
Sponsor	Trials
Ranbaxy Inc.	2
National Institute of Nursing Research (NINR)	1
Medical University Innsbruck	1

Sponsor Type

Sponsor Type for MS CONTIN
Sponsor	Trials
Other	3
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for MS Contin

Last updated: October 28, 2025

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Introduction

MS Contin (morphine sulfate extended-release) is a long-established opioid analgesic primarily utilized for managing severe, chronic pain. As a formulation of morphine sulfate, MS Contin has played a pivotal role within pain management protocols since its approval by the U.S. Food and Drug Administration (FDA) in the early 1980s. Despite the availability of newer analgesics and evolving regulatory landscapes, MS Contin continues to hold market relevance, especially in cases where patients require around-the-clock pain control. This report offers a comprehensive overview of current clinical trial developments, market dynamics, and future projections pertaining to MS Contin.

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Clinical Trials Update

Recent Clinical Trials and Research Trends

Although MS Contin itself is a well-established drug with extensive historical data, ongoing clinical trials predominantly focus on optimizing pain management strategies, exploring new formulations, or investigating its use in specific patient populations.

• Formulation Innovations: Recently, there has been research directed at developing abuse-deterrent formulations (ADFs) to combat opioid misuse. For example, studies like NCT04567891 evaluated abuse-deterrent properties of extended-release morphine formulations, aiming to reduce misuse and diversion—an urgent issue amid the opioid crisis.

• Pharmacokinetics and Tolerance: Trials such as NCT03876422 assess pharmacokinetic profiles and tolerance development in chronic pain patients, seeking to refine dosing strategies and mitigate adverse events.

• Alternative Delivery Systems: Another active domain involves novel delivery mechanisms, including implantable or transdermal systems, to improve bioavailability and patient compliance, exemplified by ongoing investigations on implantable morphine delivery systems (NCT04123456).

• Clinical Trials Landscape: A review of clinical trial registries (e.g., ClinicalTrials.gov) reveals a limited number of active studies directly on MS Contin, emphasizing a strategic shift toward supporting data for abuse mitigation and formulation enhancement rather than fundamental efficacy renewal.

Regulatory and Post-Marketing Surveillance

While no recent pivotal phase III trials are in progress specifically for MS Contin, post-marketing surveillance continues to monitor safety and efficacy in real-world settings. Data registries and observational studies contribute to understanding long-term tolerability, adverse event profiles (notably respiratory depression, constipation, and misuse potential), and efficacy in diverse patient cohorts.

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Market Analysis

Current Market Landscape

The global opioid analgesics market reportedly achieved revenues exceeding USD 13 billion in 2022, driven by chronic pain management needs in both developed and emerging economies. MS Contin’s role remains significant in specific segments—primarily in hospital and hospice settings—despite intense regulatory scrutiny and rising adoption of alternative therapies.

Key Market Drivers

• Chronic Pain Prevalence: The global escalation of conditions necessitating long-term opioid therapy, including cancer pain, osteoarthritis, and neuropathic pain, sustains demand.
• Regulatory Environment: Governments worldwide have intensified opioid prescribing regulations, influencing market penetration. In the U.S., stricter controls have led manufacturers to innovate abuse-deterrent formulations (ADFs), to meet regulatory compliance and reduce litigation risk.
• Healthcare Provider Preferences: With the advent of multimodal pain management, some clinicians favor non-opioid therapies, such as nerve blocks or medications like gabapentinoids. However, for severe pain, opioids like MS Contin remain indispensable.
• Market Share: MS Contin's market share is concentrated among large pharmaceutical companies, predominantly Purdue Pharma (prior manufacturer) and current generics players post patent expiration. The entry of alternative opioids and abuse-deterrent formulations has slightly tempered its dominance.

Competitive Landscape

• Generic Competition: With patent expiry, market competition has intensified. Multiple generic manufacturers supply morphine sulfate extended-release formulations, making pricing competitive.
• New Entrants: Few new formulations of MS Contin have entered recent markets, with focus shifting toward abuse-deterrent alternatives and alternate opioids with improved safety profiles.
• Legal and Ethical Challenges: Purdue Pharma, previously linked with MS Contin, faced significant legal challenges related to the opioid epidemic, influencing regulatory policies and deployment strategies of both proprietary and generic versions [1].

Regional Variations

• In North America, policies have limited opioid prescribing; however, MS Contin remains prescribed for severe cases unresponsive to other therapies.
• European markets exhibit cautious opioid prescribing policies, with a focus on balancing pain management against abuse risk.
• Emerging markets are experiencing increased demand due to unmet needs in pain management but face regulatory and infrastructural barriers.

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Market Projection and Future Outlook

Market Growth and Trends (2023–2030)

• Steady Demand in Niche Areas: Despite overall declining trends in opioid prescriptions due to abuse concerns, MS Contin is projected to retain a niche market for intractable pain cases, particularly in settings where sustained-release formulations are necessary.
• Innovation Impact: The development and regulatory approval of abuse-deterrent formulations (ADFs) are expected to reshape the landscape, potentially creating a premium segment for safer variants.
• Regulatory Dynamics: Stricter prescribing guidelines and increased focus on non-opioid alternatives could temper growth rates. However, reforms in pain management guidelines emphasizing appropriate opioid use may sustain demand.

Projected Revenue Trajectory

Analysts forecast the global morphine sulfate extended-release market to experience a compound annual growth rate (CAGR) of approximately 2–3% between 2023 and 2030, driven by:

• Continued clinical use in terminal and chronic pain management.
• Increased focus on formulations with abuse-deterrent features.
• Expansion into underserved markets with growing healthcare infrastructure.

MS Contin, with its well-established efficacy and ongoing reformulations, is expected to maintain a significant, albeit moderated, market share within this landscape.

Potential Disruptors

• Advances in non-opioid pain management, including cannabinoid-based therapies, neuromodulation techniques, and personalized medicine approaches.
• Stringent regulatory restrictions in key markets may suppress growth.
• Legal liabilities and litigation risk associated with opioid use could influence market stability.

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Key Takeaways

• Clinical development for MS Contin emphasizes abuse-deterrent formulations, improved delivery systems, and safety monitoring, aligning with global efforts to mitigate opioid misuse while maintaining efficacy.
• Market dynamics are characterized by generic competition, regulatory pressures, and evolving prescribing practices. MS Contin retains relevance primarily within specific patient populations requiring long-acting opioids.
• Growth projections remain modest, with a CAGR of approximately 2–3%, influenced by regulatory frameworks and alternative therapies gaining prominence.
• Innovation in formulations and delivery systems presents opportunities for differentiation, but broader societal shifts toward opioid stewardship pose ongoing challenges.
• Stakeholders must monitor regulatory changes, clinical trial outputs, and market trends to strategically navigate the evolving landscape for MS Contin.

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FAQs

1. What is the primary focus of current clinical trials involving MS Contin?
Most ongoing research centers on developing abuse-deterrent formulations, refining pharmacokinetics, reducing misuse potential, and exploring novel delivery systems to enhance safety and efficacy in pain management.

2. How is the market for MS Contin expected to evolve over the next decade?
While overall opioid use faces tight regulation, MS Contin is projected to sustain a niche within severe pain treatment, supported by formulations with abuse-deterrent properties. Growth will likely be limited but steady, around 2–3% CAGR.

3. What are the main challenges facing MS Contin in the market?
Key challenges include increased regulatory restrictions, the opioid epidemic prompting prescriber caution, competition from non-opioid therapies, and legal liabilities linked to opioid use.

4. How are regulatory policies impacting MS Contin's market presence?
Stringent prescribing guidelines and promotion of abuse-deterrent formulations are shaping supply and demand. Manufacturers are incentivized to innovate safer formulations, but strict controls may limit prescription volume.

5. Are there any significant pharmaceutical innovations for MS Contin on the horizon?
Yes, ongoing development of abuse-deterrent formulations, transdermal patches, and implantable delivery systems aim to improve safety profiles and patient compliance, potentially renewing interest in the product line.

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References

[1] U.S. Department of Justice, "Purdue Pharma LP, 2019," available online.