CLINICAL TRIALS PROFILE FOR MS CONTIN

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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.
NCT01734252 ↗	Argatroban in Critically Ill Patients With Heparin Resistance	Completed	Medical University Innsbruck	Phase 2	2012-07-29	Critically ill patients with high risk for thrombosis or tromboembolic events with the presence of heparin resistance, treated at the Department for General and Surgical Critical Care Medicine of the Medical University Innsbruck, Austria will be enrolled in the study when meeting the inclusion- and exclusion criteria. If a patient meets the inclusion criteria and is recruited for the study, the patient will be randomized either to Group A or Group H. All patients have to achieve a prophylactic aPTT-target range of an aPTT-level of 45 - 60 sec (Pathromtin® SL) within 6 to 8 hours. Randomisation Group A: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be stopped and Argatroban will be given and adjusted until the target aPTT-range is achieved. Randomisation Group H - Standard therapy: If a Heparin resistance appears and the patient meets the inclusion and exclu-sion criteria, he/she will be enrolled. The Heparin administration will be contin-ued and, if necessary increased. Hereby the maximum heparin dose is 1.500 IU per hour. Therapy failure Group H: Primary target failure at Visit 3 (6-8 hours): If a patient of Group H does not achieve the target-aPTT within 6-8 hours, he/she will switch to Group A and will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (T1 / day 30). Maintenance failure after Visit 3: Maintenance failure after 6-8 hours is defined as non-maintenance of the tar-get-aPTT until day 7 with a max. heparin dosage of 1.500 IU per hour. In this case, heparin therapy has to be changed to Argatroban. The patient will start with T1 (Baseline) and will follow the visits according to Group A until the final Visit 9 (day 30) counting from the Baseline of Group A. Therapy failure Group A: If a patient of Group A does not achieve the target-aPTT within 6-8 hours or cannot maintain the target-aPTT in spite of reaching the maximum dosage of 10µg/kg/min during the further study period, the patient automatically drops out of the study. The same is effective for patients who switched to the Group A after a therapy failure in Group H. General: Two hours after starting the Baseline investigations, patient's parameters in-cluding blood collections will be measured for the second time (T2). Additional measurements will be made at 6-8 hours (T3), 24 hours (T4), 48 hours (T5), 5 days (T6) after start of study drug and on day 7 before (T7) stop of study medication and 6h (T8) after stop of study medication. 30 days after inclusion in the study, a final investigation is planned (T9).

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
Chronic Pain	1
Lymphoma	1
Precancerous Conditions	1
Stomatitis, Aphthous	1

Clinical Trial Locations for MS CONTIN

Trials by Country

Trials by Country for MS CONTIN
Location	Trials
Canada	4
United States	2
Austria	1
Israel	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
NCIC Clinical Trials Group	1
National Institute of Dental and Craniofacial Research (NIDCR)	1

Sponsor Type

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

MS Contin (morphine sulfate) Clinical Trials Update, Market Analysis, and Exclusivity/Generic Risk Projection

Last updated: July 28, 2026

Executive summary

• MS Contin is the brand name for extended-release morphine sulfate tablets (opioid analgesic). Commercial value depends on persistent opioid-analgesic demand, state/federal controlled-substance enforcement, and payer controls rather than on active “new” development pipelines.
• Patent and exclusivity posture is driven by older small-molecule composition, formulation (extended-release matrix), and manufacturing patents, plus any product-specific data exclusivities (if any). For a mature ER opioid like MS Contin, commercial loss of exclusivity typically precedes current market share dynamics, with generic penetration and authorized generics acting as the dominant structural forces.
• Clinical “updates” for MS Contin are primarily indirect: new ER-opioid comparative studies, safety and risk-management research, label updates, and real-world outcomes rather than Phase 3 registrational programs for MS Contin itself.

What is MS Contin and what active ingredient does it contain? MS Contin is an extended-release (ER) oral opioid formulation of morphine sulfate. It is used for the management of severe, persistent pain that requires daily, continuous opioid treatment.

How does MS Contin differ from immediate-release morphine?

• MS Contin is designed to deliver morphine over an extended dosing interval (commonly once or twice daily depending on strength and prescriber regimen).
• Compared with immediate-release morphine products, ER morphine is intended to reduce peak-trough variability and support longer analgesic coverage, shifting risk toward long-duration exposure and accumulation-based adverse effects.

What dose forms and strengths are marketed?

MS Contin is marketed as extended-release tablets in multiple strengths. The branded product’s commercial footprint is typically strength-mix dependent and highly sensitive to generic substitution at the pharmacy level.

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What clinical trials involve MS Contin, and what are the latest update themes?

Direct registrational trials for MS Contin are largely a historical footprint. Current literature is dominated by:

• Comparative effectiveness in ER opioid regimens
• Safety in chronic pain populations
• Titration, switching, and real-world adherence
• Risk mitigation studies (respiratory depression, overdose risk, misuse/diversion monitoring)

Are there active Phase 3 or registrational trials for MS Contin?

For a mature ER morphine brand, the practical expectation is that:

• New trials are usually comparative or observational rather than new NDA-enabling Phase 3 programs.
• Many “trial updates” published recently focus on ER opioid strategy broadly, not on MS Contin as the sole investigational product.

What do modern MS Contin-related studies tend to measure?

Typical endpoints in recent ER-opioid studies include:

• Pain intensity and functional outcomes (e.g., change in pain scores, sleep interference, activity)
• Opioid-related adverse events, including constipation, somnolence, nausea
• Serious outcomes tied to respiratory depression risk
• Treatment persistence, switching rates, and discontinuation

Where do label updates usually come from?

Common label update channels include:

• Postmarketing safety surveillance
• Drug utilization and overdose reporting patterns
• Risk management policy changes and REMS-adjacent communications for opioids

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How is the ER morphine market evolving versus other opioids?

Market demand for ER morphine is shaped by substitution risk, payer policies, and opioid access rules. Competitive dynamics often compare MS Contin with:

• Other ER opioids (oxycodone ER, hydrocodone ER, fentanyl transdermal, ER hydromorphone)
• “Just-in-time” generics and authorized generics
• Buprenorphine and other alternatives in some chronic pain cohorts

What is the substitution pattern at pharmacy and formulary level?

• ER morphine is exposed to rapid generic substitution because the molecule is off-patent.
• Payers increasingly prefer lower-cost generics and restrict coverage based on step edits, prior authorization, and quantity limits.
• Pharmacy-level substitution reduces branded capture even when the brand remains clinically used.

What share-impact does “opioid reform” have on MS Contin?

Policy shifts affect:

• Prescriber behaviors (tighter initiation, slower titration, lower days’ supply)
• Patient selection (more comorbidities excluded or monitored)
• Dispensing volumes (limits tied to safety metrics)

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What patents protect MS Contin and how strong is the patent estate?

MS Contin is not a high-patent-growth asset. The enforceable estate for an older ER morphine brand is typically limited to legacy formulation, dosing, or manufacturing improvements, plus any remaining product-specific patents.

What patent categories usually cover ER morphine brands?

For extended-release opioid tablets, patent coverage historically clusters into:

• Composition of matter (rarely still active for morphine sulfate itself)
• Extended-release formulation systems (polymer matrices, hydrophilic/hydrophobic blends)
• Manufacturing and coating processes
• Particle size, compression parameters, and release-rate modulation methods
• Method-of-use claims (often weaker against generic carve-outs and labeling constraints)

How many active patents are likely in force?

Given the age of morphine ER commercialization, the estate typically has few or no meaningful remaining exclusivities focused on the core ER morphine product category.

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When does MS Contin lose exclusivity and what does that mean for generics?

MS Contin’s generic entry typically already occurred structurally. For current market projection, the relevant question is not “when exclusivity ends,” but:

• whether any remaining formulation/process patents still constrain specific generics, and
• whether authorized generics or new labeling/AB-rating dynamics still preserve any branded premium.

What generic entry risks matter most today?

For MS Contin in practice, the dominant risks are:

• Ongoing generic supply and substitution depth in ER morphine
• Payer switching and automatic dispensing controls
• Litigation outcomes if any remaining patents still exist on specific strengths or manufacturing processes

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What is the Orange Book status of MS Contin (and what does it imply for Paragraph IV)?

MS Contin’s Orange Book relevance is mainly a constraint map for any remaining product-specific patents listed against the brand. Paragraph IV challenges matter only if:

• there are still Orange Book-listed patents not expired as of the challenge filing date, and
• the generic filer targets those patents.

What Orange Book listings usually look like for legacy opioids

Orange Book entries for older opioids typically include:

• patents expiring decades after initial launch only if there were later formulation/process improvements
• expiration dates that determine whether any new generic introduction triggers Hatch-Waxman dispute risks

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What patent litigation affects MS Contin?

For mature ER opioids, litigation tends to be:

• intermittent and product-specific (particular patents or manufacturing processes)
• more influential in settlement terms than in long-term market structure because generics already dominate

What settlement patterns are common in legacy opioid patent disputes?

Settlement outcomes in opioid generics often:

• establish a launch date for a competing generic
• include agreements around design-around (formulation or process changes)
• include cross-licenses for certain strengths and label carve-outs

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What generic entry risks exist for specific MS Contin strengths?

MS Contin’s commercial exposure is strength-specific because:

• different strengths may have different formulation parameters (release characteristics, excipient blends)
• ANDA approvals can be segmented by dosage form and strength
• any remaining patent coverage can be strength-scoped

What would constrain generic replacement most effectively?

The most constraining elements (when they still exist) are:

• extended-release formulation patents specific to a matrix system
• manufacturing process claims requiring a protected method to achieve release profile targets
• any remaining product-specific patents listed in the Orange Book

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How does MS Contin compare with other ER morphine products and authorized generics?

In most markets:

• The branded MS Contin competes against multiple generic morphine ER manufacturers.
• Pricing pressure is driven by the competitive generic group and contract pharmacies, not by unique clinical differentiation.

What is the practical difference between brand and generic for patient outcomes?

When generics are AB-rated for bioequivalence:

• pharmacokinetic equivalence is expected
• clinical differences are usually limited to excipient tolerability, pill handling differences, and patient-specific response variability

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Market analysis: where does MS Contin revenue come from and what are the drivers?

MS Contin demand is primarily driven by chronic pain treatment patterns and opioid prescribing intensity. Key demand drivers include:

• prevalence of chronic pain and opioid utilization rates
• ER opioid selection practices (conversion from immediate-release, switching patterns)
• formulary access, step edits, and prior authorization
• controlled-substance monitoring intensity and dispensing constraints

Pricing and reimbursement dynamics

• Branded products face net pricing compression through rebates and substitution.
• Generics reduce average net price and increase volume volatility because pharmacy switching can happen rapidly.

Distribution channel effects

• Hospital/health system formularies and specialty pharmacy contracts often dictate the branded-generic mix.
• Retail chain policies affect automatic substitution rates.

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Revenue projection for MS Contin: base, bull, and bear cases

Because MS Contin is a legacy, generic-exposed product, projections are driven by unit demand retention and net price erosion rather than incremental clinical uptake. Typical projection logic for a mature ER opioid:

• Base case: stable or declining units due to prescribing controls; continued net price decline toward generic parity.
• Bear case: faster unit declines from tighter opioid policies, litigation spillover into prescribing restrictions, and payer step-edit tightening.
• Bull case: temporary stabilization from payer contracting, slower substitution in certain geographies, or patient retention in ER morphine regimens.

What variables will move the projection most?

• ER opioid formulary stance for morphine ER vs alternatives
• Days’ supply and quantity-limit enforcement
• State-level opioid settlement-related prescribing constraints affecting chronic pain cohorts
• Net-to-gross changes driven by rebate pressure and wholesaler contracting

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What regulatory milestones matter for MS Contin today?

For a mature ER opioid:

• The primary regulatory events are label changes, safety communications, and enforcement of opioid risk mitigation requirements.
• The FDA’s ongoing opioid safety framework influences prescribing behavior and product utilization more than it changes manufacturing viability.

How do REMS and opioid safety communications affect MS Contin utilization?

• Risk messaging can reduce initiation, encourage tapering, and increase requirements for monitoring.
• That changes volume and persistence more than it impacts product-specific pharmacology.

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Geographic coverage: how do US opioid rules change the MS Contin outlook?

US-only regulatory pressure dominates:

• Controlled substance scheduling enforcement and reporting
• State monitoring programs (PDMPs)
• Payer restrictions and insurer utilization management

Internationally, ER morphine markets vary based on opioid prescribing culture, national regulations, and reimbursement structures.

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Key Takeaways

• MS Contin is a mature extended-release morphine sulfate product; clinical “updates” are mainly safety and real-world opioid-management themes rather than new registrational development.
• Market structure is governed by generic substitution and payer controls; competitive pressure is persistent and primarily price-driven.
• Patent and exclusivity influence is typically limited at this stage because morphine ER brands are legacy assets; remaining risk is product-specific and strength-specific if any late-listed formulation/process patents remain.
• Revenue outlook is dominated by net price compression and opioid policy tightening rather than by innovation-led growth.

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FAQs

1) Is MS Contin still protected by patents against generic extended-release morphine tablets?
Answer: Protection, if any, is limited to legacy formulation/process improvements and any still-active Orange Book-listed patents tied to specific strengths.

2) What is the Orange Book listing status for MS Contin and does it still drive Paragraph IV filings?
Answer: Paragraph IV risk exists only to the extent MS Contin still has unexpired Orange Book-listed patents; otherwise challenges are less relevant to new entry timing.

3) Are there current FDA label changes specific to MS Contin?
Answer: For legacy opioids, label updates most often come from postmarketing safety findings and opioid risk management communications that change prescriber behavior.

4) Does MS Contin face biosimilar-type competition?
Answer: No. Biosimilars apply to biologics; MS Contin is a small-molecule opioid.

5) How should MS Contin’s market be benchmarked against other ER opioids?
Answer: Benchmark net pricing, formulary access, and utilization management outcomes versus oxycodone ER, hydrocodone ER, and transdermal fentanyl, since these drive switching more than clinical pharmacology.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-07-28).
2. ClinicalTrials.gov. Search results for “morphine sulfate extended release” and “MS Contin.” National Library of Medicine. (Accessed 2026-07-28).
3. U.S. Food and Drug Administration opioid safety communications and labeling updates. U.S. Food and Drug Administration. (Accessed 2026-07-28).