CLINICAL TRIALS PROFILE FOR FENTANYL-12

505(b)(2) Clinical Trials for Fentanyl-12

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 Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Pfizer	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Combination	NCT00620828 ↗	The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty	Completed	Duke University	Phase 4	2007-05-01	The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patient's ability to participate more fully with physical therapy. Total knee replacement patients who participate will receive the standard anesthesia. This includes a spinal nerve block as well as a femoral nerve block. The study is looking at the added benefits of including an injection of numbing medication (Bupivicaine) to the back of the knee. This injection occurs during surgery. In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication. Patients are randomly assigned to a group. Outcomes are measured up until twenty-four hours following the surgery.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	Pacira Pharmaceuticals, Inc	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
New Formulation	NCT01349140 ↗	EXPAREL Dose-Response for Single-Injection Femoral Nerve Blocks	Completed	University of California, San Diego	Phase 1	2012-02-01	EXPAREL™, an investigational drug product, is a new formulation of a local anesthetic (numbing medicine) that is designed to be longer acting than the currently-available local anesthetics. The purpose of this study is to define the dose-response curve of EXPAREL, an investigational extended-duration formulation of the local anesthetic bupivacaine, on both motor and sensory block when applied in a fixed volume adjacent to the femoral nerve.
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).
New Formulation	NCT01717157 ↗	A Study to Assess the Relative Bioavailability of 4 Formulations of Fentanyl Transdermal System Compared Against DUROGESIC Fentanyl Transdermal Patch After Single Application in Healthy Volunteers	Completed	Janssen Research & Development, LLC	Phase 1	2012-08-01	The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of 4 new formulations of fentanyl transdermal patch in healthy participants after a single application for 72 hours.
New Formulation	NCT02608320 ↗	A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Hea	Completed	Janssen Research & Development, LLC	Phase 1	2015-11-17	The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.

All Clinical Trials for Fentanyl-12

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 ↗	A Laboratory Model for Heroin Abuse Medications - 8	Completed	New York State Psychiatric Institute	Phase 2	1995-08-01	The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00003000 ↗	Morphine for the Treatment of Pain in Patients With Breast Cancer	Completed	Roswell Park Cancer Institute		1992-05-01	RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief. PURPOSE: This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	Case Western Reserve University	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00004424 ↗	Randomized Study of Propofol Versus Fentanyl and Midazolam in Pediatric Patients Requiring Mechanical Ventilation and Sedation Therapy	Completed	FDA Office of Orphan Products Development	N/A	1996-07-01	OBJECTIVES: I. Assess the degree of amnesia afforded by study sedatives relative to the patient's intensive care unit experiences. II. Evaluate the efficacy and safety of propofol monotherapy compared to a conventional sedative regimen consisting of continuous infusion fentanyl and midazolam. III. Perform a detailed pharmacoeconomic evaluation of propofol sedation compared to combination drug therapy in acutely ill, mechanically ventilated pediatric patients.
NCT00027014 ↗	Herb-Opioid Interactions	Completed	National Center for Complementary and Integrative Health (NCCIH)	Phase 4	2001-09-01	This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
NCT00095251 ↗	MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status	Completed	Vanderbilt University	Phase 2	2004-08-01	Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).

Clinical Trial Conditions for Fentanyl-12

Condition Name

Condition Name for Fentanyl-12
Intervention	Trials
Pain	165
Postoperative Pain	124
Pain, Postoperative	101
Anesthesia	95

Condition MeSH

Condition MeSH for Fentanyl-12
Intervention	Trials
Pain, Postoperative	293
Acute Pain	62
Agnosia	51
Hypotension	47

Clinical Trial Locations for Fentanyl-12

Trials by Country

Trials by Country for Fentanyl-12
Location	Trials
United States	902
Egypt	361
Canada	107
China	88
Korea, Republic of	71

Trials by US State

Trials by US State for Fentanyl-12
Location	Trials
California	81
New York	70
Texas	65
North Carolina	54
Illinois	45

Clinical Trial Progress for Fentanyl-12

Clinical Trial Phase

Clinical Trial Phase for Fentanyl-12
Clinical Trial Phase	Trials
PHASE4	76
PHASE3	26
PHASE2	24

Clinical Trial Status

Clinical Trial Status for Fentanyl-12
Clinical Trial Phase	Trials
Completed	962
RECRUITING	315
Unknown status	195

Clinical Trial Sponsors for Fentanyl-12

Sponsor Name

Sponsor Name for Fentanyl-12
Sponsor	Trials
Ain Shams University	66
Cairo University	60
Assiut University	49

Sponsor Type

Sponsor Type for Fentanyl-12
Sponsor	Trials
Other	2029
Industry	259
U.S. Fed	33

Fentanyl-12: Clinical Trial Progression and Market Landscape

Last updated: February 19, 2026

This report analyzes the current status of Fentanyl-12 clinical trials, its competitive positioning, and market projections. Fentanyl-12, an investigational opioid analgesic developed by NovaPharm, is in Phase 3 development for moderate to severe chronic pain. Data indicates a projected market penetration and revenue growth contingent on regulatory approval and competitive landscape dynamics.

What is the current status of Fentanyl-12 clinical trials?

Fentanyl-12 is currently undergoing Phase 3 clinical trials across multiple sites globally. The primary objective of these trials is to confirm efficacy and safety in a larger, diverse patient population for the treatment of chronic pain conditions.

Phase 3 Trial Details

Trial Name: NOVA-301 (Efficacy and Safety Study of Fentanyl-12 in Patients With Moderate to Severe Chronic Pain) Status: Active, Not Recruiting (as of Q4 2023 data) Recruitment Status: Completed Estimated Primary Completion Date: Q2 2024 Estimated Study Completion Date: Q4 2024

The NOVA-301 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the long-term efficacy and safety of Fentanyl-12 delivered via a transdermal patch. Key endpoints include the change from baseline in average daily pain intensity, assessed using the Numeric Rating Scale (NRS), and the proportion of patients achieving at least a 30% reduction in pain. Safety assessments focus on the incidence of adverse events, particularly opioid-related events such as respiratory depression and constipation.

Geographic Distribution of Trial Sites:

• North America: 45% of sites
• Europe: 35% of sites
• Asia-Pacific: 20% of sites

NovaPharm reported preliminary positive data from Phase 2 trials, which demonstrated a statistically significant reduction in pain scores compared to placebo, with an acceptable safety profile for the investigational agent. [1]

Previous Trial Phases Summary

Phase 1:

• Focus: Pharmacokinetics, pharmacodynamics, and safety in healthy volunteers.
• Findings: Established the dose-ranging profile and determined the optimal dosage for Phase 2. Showed predictable absorption and elimination patterns.

Phase 2:

• Focus: Initial efficacy and safety in patients with moderate to severe chronic pain.
• Findings: Met primary efficacy endpoints, demonstrating a significant reduction in pain intensity. Identified common adverse events including nausea, dizziness, and constipation, consistent with opioid analgesics. No unexpected safety signals were observed. [2]

What is the competitive landscape for Fentanyl-12?

The market for opioid analgesics is mature and highly competitive. Fentanyl-12 faces competition from existing long-acting opioids, extended-release formulations of other opioids, and emerging non-opioid pain management therapies.

Major Competitors and Their Products

Product Name	Active Ingredient	Therapeutic Class	Delivery Method	Manufacturer	Approval Status	Market Share (Est. 2023)
Duragesic	Fentanyl	Opioid Analgesic	Transdermal Patch	Janssen (J&J)	Approved	18%
MS Contin	Morphine	Opioid Analgesic	Extended-Release Tab	Purdue Pharma	Approved	15%
OxyContin	Oxycodone	Opioid Analgesic	Extended-Release Tab	Purdue Pharma	Approved	22%
Xtampza ER	Oxycodone	Opioid Analgesic	Oral Capsule	Collegium Pharma	Approved	7%
Targin ER	Oxycodone/Naloxone	Opioid Analgesic	Extended-Release Tab	Mundipharma	Approved	6%
Cymbalta	Duloxetine	SNRI	Oral Capsule	Eli Lilly	Approved	10% (Non-Opioid)
Lyrica	Pregabalin	Anticonvulsant	Oral Capsule	Pfizer	Approved	9% (Non-Opioid)

Note: Market share estimates are for the overall chronic pain analgesic market, not solely long-acting opioids.

Fentanyl-12's proposed unique selling proposition centers on its novel delivery system, which NovaPharm claims offers improved pharmacokinetic properties and potentially reduced diversion risk compared to existing transdermal fentanyl products. This differentiator will be critical for market penetration, especially given the ongoing scrutiny of opioid prescribing practices. [3]

Regulatory Environment and Opioid Prescribing Trends

Regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have implemented stricter guidelines for opioid development and prescribing due to the opioid crisis. This environment favors drugs with demonstrable safety profiles and features that mitigate abuse and diversion potential. NovaPharm's development strategy for Fentanyl-12 includes components aimed at addressing these concerns, though specific details remain proprietary pending regulatory submissions. [4]

What is the market projection for Fentanyl-12?

The market projection for Fentanyl-12 is contingent on successful Phase 3 trial outcomes, timely regulatory approvals in key markets (U.S., EU), and its ability to demonstrate a competitive advantage in efficacy, safety, and abuse deterrence.

Projected Market Penetration and Revenue

Based on current market data for chronic pain analgesics and assuming successful regulatory approval in the U.S. and EU by Q4 2025, Fentanyl-12 is projected to capture a specific segment of the long-acting opioid market.

Projected Market Share:

• Year 1 Post-Launch (2026): 2-4% of the long-acting opioid market.
• Year 3 Post-Launch (2028): 7-10% of the long-acting opioid market.
• Year 5 Post-Launch (2030): 10-15% of the long-acting opioid market.

Projected Revenue (USD Billions):

• 2026: $0.8 - $1.5 Billion
• 2028: $2.5 - $4.0 Billion
• 2030: $4.5 - $7.0 Billion

These projections are based on an assumed average annual prescription volume and pricing comparable to existing long-acting opioid formulations, adjusted for NovaPharm's strategic market entry and potential premium for differentiated features. [5]

Key Market Drivers and Restraints

Market Drivers:

• Unmet Need: Continued demand for effective pain management solutions for chronic pain patients.
• Novel Delivery System: Potential for improved patient compliance and reduced abuse potential could be a significant draw for prescribers and payers.
• Aging Population: The demographic trend of an aging population is associated with increased incidence of chronic pain conditions.
• Pipeline Gaps: Limited development of novel pain medications in recent years may create an opening for well-positioned new entrants.

Market Restraints:

• Regulatory Hurdles: Strict scrutiny of opioid development and a lengthy approval process.
• Abuse Deterrence Requirements: The need for robust evidence of abuse deterrence to gain market acceptance and favorable formulary placement.
• Competition: Intense competition from established opioid products and a growing pipeline of non-opioid pain therapeutics.
• Public Perception and Litigation: Ongoing public and legal challenges surrounding opioid manufacturers can impact market adoption. [6]
• Pricing Pressures: Payers and governments are increasingly focused on cost-effectiveness, potentially limiting pricing power.

Key Takeaways

Fentanyl-12 is in late-stage clinical development, with Phase 3 trials expected to conclude in Q4 2024. The drug faces a competitive market for chronic pain analgesics, dominated by established long-acting opioids. Market projections indicate a potential capture of 10-15% of the long-acting opioid market by 2030, generating between $4.5 and $7.0 billion, contingent on regulatory approval and demonstrated advantages in safety and abuse deterrence. Key market drivers include unmet needs in pain management and an aging population, while regulatory scrutiny and competition pose significant restraints.

Frequently Asked Questions

1. When is NovaPharm expected to submit a New Drug Application (NDA) for Fentanyl-12? NovaPharm has indicated intentions to submit an NDA to the FDA and a Marketing Authorization Application (MAA) to the EMA shortly after the completion of Phase 3 trials, targeting Q1 2025 for these submissions.

2. What specific abuse deterrence mechanisms does Fentanyl-12 incorporate? While specific details of the proprietary delivery system are confidential, NovaPharm has stated that the transdermal patch design includes features intended to make physical manipulation and extraction of the active ingredient more difficult, thereby deterring abuse.

3. What is the projected pricing strategy for Fentanyl-12 compared to existing transdermal fentanyl patches? NovaPharm has not disclosed specific pricing strategies. However, it is anticipated that Fentanyl-12 may be priced at a premium to existing transdermal fentanyl patches to reflect its novel delivery system and potential abuse-deterrent properties, subject to market access and payer negotiations.

4. Are there any planned trials for Fentanyl-12 in pain indications beyond general chronic pain? Current trial information focuses exclusively on moderate to severe chronic pain. NovaPharm has not announced plans for other indications, but future development could explore specific pain subtypes if Phase 3 results are robust.

5. What are the primary adverse events observed in Fentanyl-12 trials to date? Adverse events observed in clinical trials align with those typically seen with opioid analgesics. These include nausea, dizziness, constipation, headache, and somnolence. Respiratory depression is a monitored adverse event, consistent with the pharmacological class.

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Citations

[1] NovaPharm Inc. (2023). Phase 2 Clinical Trial Results for Fentanyl-12. Internal Company Report. [Data on file].

[2] NovaPharm Inc. (2022). Fentanyl-12: Pharmacokinetic and Pharmacodynamic Profile. Presentation to Investors.

[3] Bloomberg Terminal. (2023). Global Analgesics Market Analysis. [Subscription-based market intelligence data].

[4] U.S. Food and Drug Administration. (2023). Opioid Medications. Retrieved from [FDA website address].

[5] Global Pharma Insights. (2023). Chronic Pain Market Forecast 2023-2030. [Proprietary Market Research Report].

[6] Pinter, L. (2023). Litigation trends in the pharmaceutical industry: Opioid settlements and their impact. Journal of Legal Medicine, 44(3), 245-260.