CLINICAL TRIALS PROFILE FOR DEMEROL

505(b)(2) Clinical Trials for DEMEROL

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
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for DEMEROL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Science Council, Taiwan	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00154895 ↗	Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax	Unknown status	National Taiwan University Hospital	Phase 3	2001-06-01	To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
NCT00240123 ↗	Effect of Benadryl Sedation During ERCP or EUS	Withdrawn	University of Rochester	Phase 1	2005-07-01	The purpose of the study is to determine if adding Benadryl improves sedation for patients scheduled to undergo ERCP or EUS procedures.
NCT00274170 ↗	Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache	Unknown status	C.R.Darnall Army Medical Center	Phase 1/Phase 2	2006-01-01	: Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p
NCT00583869 ↗	Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients	Completed	Pfizer	Early Phase 1	2007-05-01	This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.
NCT00583869 ↗	Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients	Completed	University of Alabama at Birmingham	Early Phase 1	2007-05-01	This is a randomized, prospective, double-blind pilot study designed to evaluate the potential effectiveness of pregabalin in post-operative pain management for patients who have sustained a fracture.

Clinical Trial Conditions for DEMEROL

Condition Name

Condition Name for DEMEROL
Intervention	Trials
Parkinson's Disease	1
Cesarean Section Complications	1
Pneumothorax	1
Gallbladder Disease	1

Condition MeSH

Condition MeSH for DEMEROL
Intervention	Trials
Pancreatitis	1
Anemia	1
Preleukemia	1
Jaundice	1

Clinical Trial Locations for DEMEROL

Trials by Country

Trials by Country for DEMEROL
Location	Trials
United States	15
Canada	2
Taiwan	1

Trials by US State

Trials by US State for DEMEROL
Location	Trials
Texas	3
Ohio	1
North Carolina	1
New York	1
Massachusetts	1

Clinical Trial Progress for DEMEROL

Clinical Trial Phase

Clinical Trial Phase for DEMEROL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DEMEROL
Clinical Trial Phase	Trials
Completed	5
Terminated	2
Unknown status	2

Clinical Trial Sponsors for DEMEROL

Sponsor Name

Sponsor Name for DEMEROL
Sponsor	Trials
Centre hospitalier de l'Université de Montréal (CHUM)	1
C.R.Darnall Army Medical Center	1
Pfizer	1

Sponsor Type

Sponsor Type for DEMEROL
Sponsor	Trials
Other	12
U.S. Fed	1
Industry	1

Clinical Trials Update, Market Analysis, and Projection for Demerol (Meperidine)

Last updated: October 28, 2025

Introduction

Demerol (meperidine) has historically been a mainstay in acute pain management since its approval in the mid-20th century. Despite its widespread use, emerging safety concerns and evolving regulatory landscapes have significantly influenced its clinical and commercial prospects. This report provides a comprehensive review of current clinical trials, market dynamics, and future projections for Demerol, emphasizing its relevance within the broader analgesic market.

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Clinical Trials Landscape for Demerol

Historical Context and Recent Clinical Investigations

Demerol's clinical utility was established primarily during the mid-20th century, with its pharmacodynamics characterized by potent mu-opioid receptor agonism. However, growing evidence of adverse effects, particularly neurotoxicity, seizures, and reports of fatalities associated with accumulation, prompted regulatory agencies, including the U.S. Food and Drug Administration (FDA), to restrict its use (FDA, 2019).

In recent years, there has been a marked decline in active clinical trials involving Demerol. According to ClinicalTrials.gov, there are currently no ongoing Phase I, II, or III trials evaluating Demerol specifically. The majority of recent research focuses on alternative opioids and non-opioid analgesics with improved safety profiles.

New Investigations and Off-Label Use

Some retrospective studies and meta-analyses continue to examine the safety and efficacy of Demerol in specific contexts, such as postoperative pain management in certain hospitals. Nonetheless, these are primarily observational, lacking robust randomized controlled trial (RCT) data, thus limiting their influence on prescribing guidelines.

Regulatory and Safety Challenges

Regulatory restrictions have led to Demerol's classification as a drug with limited indications. The FDA's 2018 warning regarding the risk of neurotoxicity and seizures significantly impacted its clinical utilization. Consequently, new clinical development pathways are highly unlikely, confining Demerol to a declining niche with minimal active research prospects.

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Market Analysis of Demerol

Historical Market Performance

Demerol's peak market penetration occurred during the 1960s-1980s, driven by its potency and fast onset of action. It was widely used in hospital settings, including emergency departments and surgical pain management.

However, the emergence of newer, safer opioids—such as fentanyl, oxycodone, and hydromorphone—alongside increased awareness of adverse effects, led to a substantial decline in Demerol's prescriptions from the early 2000s onwards ([2]).

Current Market Dynamics

Today, the Demerol market is virtually obsolete, primarily constrained to legacy drug inventories and specific niche applications where alternative options are contraindicated or unavailable. The annual global sales are estimated to be less than USD 10 million, compared to billions during its heyday ([3]).

Regulatory Impact and Market Restrictions

Regulatory agencies worldwide have implemented strict controls over opioid formulations, further restricting Demerol's availability. The US DEA classifies it as a Schedule II substance, reflecting its high abuse potential. This classification restricts its prescription and distribution, impacting market size.

Competitive Landscape

The contemporary market for opioid analgesics is characterized by a proliferation of advanced formulations and multimodal pain management strategies. Multisource generic opioids now dominate, with Demerol holding a negligible market share.

Future Market Projection

Given current trends, Demerol's market is expected to continue its decline or remain dormant:

• No new formulations or formulations reformulated for safety are anticipated.
• The drug's use will likely be restricted to legacy systems or specific cases with no alternatives.
• Market analysts project a negligible growth or further obsolescence over the next decade.

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Future Outlook and Strategic Considerations

Pharmacovigilance and Safety Concerns

The primary barrier to Demerol's resurgence is its unfavorable safety profile. The risks of neurotoxicity, seizures, and accumulated toxicity in renal impairment outweigh its benefits, prompting regulatory bodies to favor alternative therapies.

Potential for Reformulation or Reintroduction

Reformulation or structural modification to mitigate adverse effects appear financially and scientifically unviable given the extensive historical data and current priorities in pain management.

Position in the Evolving Pain Market

The opioid crisis has shifted focus toward non-addictive pain relievers and opioid-sparing modalities. As such, Demerol's repositioning within this landscape remains highly unlikely.

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Key Takeaways

• Clinical Research: No active clinical trials or investigations into Demerol are underway; safety concerns hinder further development.

• Market Status: The Demerol market has drastically contracted, with minimal sales and usage confined to legacy contexts.

• Regulatory Environment: Stricter controls and adverse event reports have led to significant restrictions, further diminishing market potential.

• Future Projections: Demerol's commercial relevance is expected to diminish further, with no substantial recovery anticipated.

• Strategic Implication: For pharmaceutical stakeholders, Demerol represents a historically significant but currently obsolete analgesic with limited future prospects.

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FAQs

1. Why has Demerol (meperidine) fallen out of favor compared to other opioids?
The decline is primarily due to its safety profile, including risks of neurotoxicity, seizures, and accumulation in renal impairment. Regulatory agencies have restricted its use, and safer alternatives with better safety margins have become preferred.

2. Are there any ongoing clinical trials exploring new formulations of Demerol?
No; the latest searches indicate no active clinical trials or research projects focusing on Demerol, reflecting its diminished clinical relevance.

3. Can Demerol be legally prescribed today?
Yes, in some jurisdictions, Demerol remains a Schedule II controlled substance, allowing limited prescribing in specific circumstances, typically when alternatives are unsuitable.

4. What are the main competitors to Demerol in the analgesic market?
Contemporary opioid options like fentanyl, morphine, hydromorphone, and non-opioid analgesics such as NSAIDs and acetaminophen dominate the market.

5. Is there any potential for Demerol to be reintroduced into the market?
Unlikely, given its safety concerns, regulatory restrictions, and the availability of safer alternatives. Reformulation efforts are not currently underway or financially justified.

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References

[1] FDA. (2019). Safety Announcement—FDA Advises Healthcare Professionals Not to Use Meperidine (Demerol) for Pain Management. U.S. Food and Drug Administration.

[2] MarketWatch. (2021). Opioids Market Overview.

[3] IQVIA. (2022). Global Opioid Sales and Market Trends Report.

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