CLINICAL TRIALS PROFILE FOR PERCOCET

505(b)(2) Clinical Trials for PERCOCET

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	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC	NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.

All Clinical Trials for PERCOCET

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00245375 ↗	A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery	Completed	Nova Scotia Health Authority	N/A	2005-01-01	Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
NCT00444808 ↗	Analgesic Effect of Intranasal Calcitonin on Patients With Fractured Ribs	Terminated	Université de Montréal	Phase 4	2007-02-01	This study, which will be conducted at the emergency room of the Sacré-Cœur hospital, requires the recruitment of 60 subjects and involves some telephone follow-up. Calcitonin administered as an intranasal spray is already used to relieve pain caused by broken vertebrae and we seek to determine if it can be as efficient in the case of pain caused by broken ribs.This study aims at testing the hypothesis that subjects suffering from the accidental fracture of one or more ribs will get relief through the intranasal spraying of calcitonin and/or will use less opiate medication for pain relief (a combination of oxycodone chlorhydrate and acetaminophen called Percocet®).

Clinical Trial Conditions for PERCOCET

Condition Name

Condition Name for PERCOCET
Intervention	Trials
Pain	11
Postoperative Pain	4
Pain, Postoperative	3

Condition MeSH

Condition MeSH for PERCOCET
Intervention	Trials
Pain, Postoperative	12
Fractures, Bone	3
Osteoarthritis	2

Clinical Trial Locations for PERCOCET

Trials by Country

Trials by Country for PERCOCET
Location	Trials
United States	58
Canada	7
Israel	1

Trials by US State

Trials by US State for PERCOCET
Location	Trials
New York	15
Florida	3
California	3
Texas	3
Indiana	2

Clinical Trial Progress for PERCOCET

Clinical Trial Phase

Clinical Trial Phase for PERCOCET
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	23
Phase 3	7

Clinical Trial Status

Clinical Trial Status for PERCOCET
Clinical Trial Phase	Trials
Completed	31
Terminated	6
Recruiting	5

Clinical Trial Sponsors for PERCOCET

Sponsor Name

Sponsor Name for PERCOCET
Sponsor	Trials
Montefiore Medical Center	4
New York University School of Medicine	3
NYU Langone Health	3

Sponsor Type

Sponsor Type for PERCOCET
Sponsor	Trials
Other	60
Industry	8
NIH	5

Percocet (oxycodone/acetaminophen): Clinical Trials Update, Market Analysis, and Projections

Last updated: April 26, 2026

What is Percocet and what trial landscape matters for it?

Percocet is a brand of oxycodone hydrochloride plus acetaminophen oral tablets (and historically extended-release variants), marketed by Endo/now part of Malabar or related legacy entities after corporate transitions. Because Percocet is an established, widely marketed opioid combination, the clinical-trial “signal” typically concentrates on:

• Reformulations and abuse-deterrent presentations (product-specific)
• Bioequivalence and generics (often fewer brand-led label-expansion trials)
• Risk-management and real-world outcomes (public health monitoring rather than new efficacy endpoints)

What do recent clinical-trial updates show?

A brand-leading developer program for a mature opioid combo is typically not built around new phase 3 efficacy each cycle. For Percocet specifically, the dominant public availability pattern in clinical registers is limited brand-led interventional activity relative to:

• Generic approvals that do not require brand-sponsored trials as published interventional studies
• Non-interventional outcomes studies that track misuse, prescribing patterns, or overdose trends
• Abuse-deterrent opioid development that competes at the class level, not strictly as “Percocet trials”

Result: there is no single, clearly attributable recent, brand-sponsored pivotal development program for Percocet that would drive a near-term label-change step function in the way seen with newer specialty analgesics. The more actionable development read-through is at the category level: opioid risk frameworks, prescribing restrictions, and state/federal enforcement that indirectly affect market access and demand.

Which endpoints and trial types are most relevant for investment decisions?

For Percocet, the decision-grade endpoints that tend to matter are not novel analgesic efficacy; they are risk and usability measures that influence formulary access:

• Abuse-deterrence performance for physical/chemical modification (where applicable)
• Safety tolerability in labeled populations (hepatic risk is a persistent issue due to acetaminophen)
• Drug interaction profiles relevant to common co-medications
• Real-world adherence to dosing limits (acetaminophen daily maximum constraints)

How does this affect near-term “clinical update” interpretation?

For a mature opioid combination, the most investable implication of clinical-trial activity is not “new efficacy,” it is whether there is:

• A new product presentation that changes abuse-deterrence classification
• A label update that improves prescriber comfort or reduces contraindication scope
• A safety signal that drives restrictions, REMS-like controls, or insurer edits

On that basis, the clinical-trial update for Percocet is best treated as stable rather than programmatic: major market movements are more likely to come from payer policy, distribution limits, litigation/regulatory actions, and class-level opioid stewardship rather than from new Percocet pivotal trial readouts.

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How big is the Percocet market and what drives demand?

Percocet sits in the oral opioid analgesic segment with acetaminophen combination products. Market size is influenced by:

• Chronic pain prevalence and prescribing rates
• Switching toward alternative opioid formats (including ER opioids where clinically appropriate, and non-opioid analgesics)
• State and insurer policy constraints (quantity limits, step therapy, prior authorization)
• Regulatory and legal pressure on manufacturer and distribution channels

Demand drivers (positive)

• Persistent use in moderate to severe pain where clinicians still choose combination therapy
• Generic penetration does not erase demand; it shifts revenue from brand to net price and contract dynamics

Demand headwinds (negative)

• Reduced opioid prescribing per CDC and payer rules
• Acetaminophen safety concerns leading to dose-limit enforcement and prescriber caution
• Increased scrutiny and litigation risk affecting channel stability

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Market structure: brand economics under generic competition

Percocet is a branded product in a segment where generics and authorized equivalents are the norm. The practical market question is therefore not “is the product used,” it is:

• How much brand volume persists
• How much net price resilience remains after wholesaler and payer contracting
• How payer formularies treat oxycodone/acetaminophen combinations versus single-entity or abuse-deterrent alternatives

This structure generally produces:

• Flat-to-declining brand revenue growth
• More volatility in net sales tied to contracting and settlement-driven channel effects
• Slower growth relative to non-opioid analgesics and niche pain products

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What is the projection outlook for Percocet?

Because Percocet is mature and faces:

• Persistent opioid stewardship pressure
• Generic-driven price competition
• Ongoing litigation/regulatory overhang that can alter market access

…the base-case projection for Percocet is typically:

• Low single-digit or flat unit growth at most
• Declining brand net sales unless there is a meaningful channel stabilization or product-specific advantage that preserves pricing

Projection framework (base case)

• Units: stable to modest downtrend as prescriber behavior continues to shift away from opioids
• Net price: down due to generic substitution and payer bargaining
• Net sales: near-term pressure, with any upside tied to payer re-inclusion, contract relief, or shifts in pain-management practice

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How does regulation and litigation risk translate into market access?

Percocet market behavior is heavily correlated with opioid policy enforcement:

• Prescription monitoring programs and dosing guidance
• State-level prescribing restrictions
• Payer utilization management (prior auth, quantity limits, step therapy)

On the litigation/regulatory side, enforcement can impact:

• Availability through channel adjustments
• Contracting and pricing leverage
• Brand strategy and willingness to invest in new presentations

This is why “clinical trial updates” are a secondary driver for Percocet compared with policy and contracting.

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Competitive set and substitution risk

The closest competitive substitutes for Percocet include:

• Other oxycodone combinations (or equivalent short-acting opioids with different acetaminophen arrangements)
• Abuse-deterrent opioid formulations in the class that payers may prefer
• Non-opioid analgesics and adjuvant regimens that reduce opioid reliance
• Single-entity opioids where acetaminophen constraints drive conversion

Because many of these products compete on payer preference and perceived safety management rather than on new clinical efficacy, substitution risk remains high even if clinical evidence is stable.

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What should businesses monitor to update the projection (leading indicators)?

Percocet outlook updates tend to show up first in:

• Payer formulary decisions for oxycodone/acetaminophen combinations
• State enforcement trends on opioid prescribing and quantity limits
• Wholesaler and channel inventory dynamics
• Contract net price movement (rebates, chargebacks, GPO dynamics)
• Portfolio actions by the brand owner (discontinuations, reformulations, bundling)

These indicators provide faster signals than new trial results.

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Key Takeaways

• Percocet’s clinical-trial relevance is mostly product presentation and risk management, not new pivotal efficacy.
• Market performance is driven more by generic competition, payer policy, and opioid stewardship than by new interventional trial results.
• Base-case outlook is stable units with brand net sales pressure, unless channel access and net pricing stabilize through policy or contract changes.
• Leading indicators for re-forecasting are formulary and utilization management decisions, state prescribing enforcement trends, and net price movement, not label-expansion trials.

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FAQs

1. Is Percocet currently seeing new phase 3 pivotal trials that could change its label?
   Percocet’s public clinical development signal is not characterized by frequent brand-led pivotal efficacy expansions; market access changes are more commonly policy-driven than trial-driven.

2. What most affects Percocet demand: clinical evidence or payer and regulatory controls?
   Payer utilization management and opioid stewardship controls are typically the dominant demand drivers because they shape prescribing behavior and covered use.

3. How does generic competition impact Percocet’s financial outlook?
   Generics typically reduce brand net pricing and shift revenue toward lower net prices through contracting, rebates, and substitution, producing a structurally constrained brand-growth profile.

4. What risk factors matter most for oxycodone/acetaminophen combinations?
   The acetaminophen dosing ceiling and hepatic risk influence prescriber behavior and dose-limit enforcement, which can cap utilization and drive substitution.

5. What is the fastest way to detect a shift in Percocet market trajectory?
   Monitor formulary and utilization management updates, quantity-limit trends, and net price movement in contracting, since these show up earlier than brand trial readouts.

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drug trials snapshots and drug safety communications (oxycodone/acetaminophen products). FDA. https://www.fda.gov/
[2] Centers for Disease Control and Prevention. (n.d.). Opioids and prescription guidance (CDC recommendations and overdose prevention resources). CDC. https://www.cdc.gov/
[3] ClinicalTrials.gov. (n.d.). Search results for oxycodone hydrochloride and acetaminophen (Percocet and related products). U.S. National Library of Medicine. https://clinicaltrials.gov/