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Last update 25 Oct 2025

Oxycodone

Last update 25 Oct 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryOxycodone, a potent opioid analgesic, also referred to as a narcotic, is a medication used in the management of pain. It functions by binding to the mu, kappa, and delta receptors located in the brain and spinal cord. The elaborate chemical name of oxycodone is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Collegium, a reputable pharmaceutical corporation, manufactures and markets this medication, which is authorized for use in the United States and China. Oxycodone, a robust painkiller, is efficacious in managing a broad spectrum of moderate to severe pain, including pain caused by cancer, surgical procedures, or injuries. Nonetheless, owing to its potential for addiction and abuse, it is classified as a controlled substance and must be used only as prescribed by a licensed healthcare provider.

Drug Type

Small molecule drug

Synonyms

(-)-14-Hydroxydihydrocodeinone, 4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one, 4,5alpha-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one

+ [21]

Target

Opioid receptors

Action

agonists

Mechanism

Opioid receptors agonists(Opioid receptors agonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

PainPain, PostoperativeAcute Pain

Inactive Indication

Cancer PainChronic PainDrug abuse+ [3]

Originator Organization

Collegium Pharmaceutical, Inc.

Active Organization

Napp Pharmaceutical Holdings Ltd.

Collegium Pharmaceutical, Inc.

Ensysce Biosciences, Inc.

Inactive Organization

Mundipharma Research GmbH & Co. KG

Beijing Mengdi Pharmaceutical Co. Ltd.Grunenthal SA

License Organization

Quotient Sciences Ltd.

Ensysce Biosciences, Inc.

DURECT Corp.

+ [1]

Drug Highest PhaseApproved

First Approval Date

China (21 Jan 2004),

Pain

RegulationBreakthrough Therapy (United States), Fast Track (United States)

Structure/Sequence

Molecular FormulaC18H21NO4

InChIKeyBRUQQQPBMZOVGD-XFKAJCMBSA-N

CAS Registry76-42-6

117

Clinical Trials associated with Oxycodone

NCT06602271

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty

The goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is:
• To assess the analgesic efficacy of PF614 compared to oxycodone hydrochloride (an immediate-release opioid analgesic) and placebo in subjects with moderate to severe pain following abdominoplasty Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 6 hours after surgery for up to 4 days.
Participants will be asked to:
* Rate their pain on a 0-10 numerical rating scale (NRS) at various timepoints up to 5 days following surgery;
* Tell us about the need for rescue medication if they continue to have moderate-to-severe pain;
* Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications;
* Provide periodic blood samples to help us understand how much study drug is in their system.
Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery. We anticipate that participants will be discharged on Day 5, pending medical review, and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge.

Start Date01 Mar 2025

Sponsor / Collaborator

Ensysce Biosciences, Inc.

ITMCTR2024000763

/ SuspendedPhase 4IIT

he Application of Transcutaneous Acupoint Electrical Stimulation Combined with Oxycodone in the Perioperative Period

Start Date03 Dec 2024

Sponsor / Collaborator

Xuzhou City Hospital of TCM

NCT06500793

/ RecruitingPhase 1

A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 When PF614 Capsule is Co Administered With Nafamostat as a Combination IR Solution and ER Capsule Formulation in Healthy Subjects

A single and multiple-dose dose study to assess the pharmacokinetics (PK) of oxycodone, when PF614 is administered alone and with nafamostat as an immediate-release (IR) solution and/or extended-release(ER) capsule prototypes.

Start Date24 Nov 2024

Sponsor / Collaborator

Ensysce Biosciences, Inc.

[+1]

100 Clinical Results associated with Oxycodone

100 Translational Medicine associated with Oxycodone

100 Patents (Medical) associated with Oxycodone

6,803

Literatures (Medical) associated with Oxycodone

01 Apr 2026·BIOMATERIALS

IFN-γ and TLR agonist co-adjuvants enhance the efficacy of a lipid-PLGA hybrid nanoparticle-based oxycodone vaccine

Article

Author: Hamid, Fatima A ; Rostamizadeh, Kobra ; Marecki, Courtney ; Zhang, Chenming ; Pravetoni, Marco ; Ci, Qiaoqiao ; Qian, Zhen ; Walter, Debra L ; Bian, Yuanzhi ; DeHority, Riley

The ongoing opioid epidemic continues to drive high rates of substance use disorders (SUD), fatal and non fatal overdoses, with oxycodone being one of the most widely misused prescription opioids. Immunopharmacological strategies such as vaccines that induce drug-specific antibodies offer a non-addictive, long-lasting approach to neutralize opioids in the bloodstream and prevent their entry into the central nervous system (CNS). In this study, we evaluated the immunogenicity and efficacy of novel oxycodone vaccine formulations incorporating interferon-γ (IFN-γ), either alone or in combination with toll-like receptor (TLR) agonists, delivered via either conventional hapten-carrier conjugates or lipid-PLGA hybrid nanoparticles (hNPs). All adjuvanted formulations elicited robust anti-oxycodone IgG responses, with IFN-γ + TLR agonist combinations particularly in the hNP platform producing the highest titers and enhanced antibody affinity. Subclass analysis, performed on the hNP-based vaccines, revealed IgG1-dominant responses, with modest IgG2a induction in the TLR-adjuvanted groups, suggesting partial Th1 skewing. Pharmacokinetic studies showed significantly elevated serum and reduced brain oxycodone levels in all vaccinated animals, with the hNP-based vaccine adjuvanted with IFN-γ and R848 providing the most potent CNS protection. In the hot plate assay, all formulations significantly attenuated oxycodone-induced antinociception, with the hNP-based vaccine formulated with IFN-γ and poly I:C producing the greatest reduction. These findings demonstrate that co-delivery of IFN-γ and a TLR agonist via a nanoparticle platform enhances both the magnitude and functional quality of the immune response, supporting further development of this strategy as a promising therapeutic approach for opioid use disorder.

31 Dec 2025·Canadian Journal of Pain-Revue Canadienne de la Douleur

Percutaneous auricular neuromodulation to treat pain after ambulatory breast surgery: A randomized, double-masked, sham-controlled pilot study

Article

Author: Sztain, Jacklynn F. ; Schaar, Adam ; Ilfeld, Brian M. ; Griggs, Jonna L. ; Said, Engy T. ; Abdullah, Baharin ; Abramson, Wendy B. ; Finneran, John J. ; Wallace, Anne M. ; Jensen, Evan J.

Introduction:

Percutaneous auricular neuromodulation involves implanting electrodes around the ear and administering an electric current. A device is currently available that is cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. This randomized, controlled pilot study aimed to (1) assess the feasibility of a postoperative auricular neuromodulation protocol and (2) provide an estimate of its treatment effects on postoperative pain and opioid consumption.

Methods:

Adults undergoing unilateral or bilateral ambulatory breast surgery with anticipated moderate-severe pain and a single-injection paravertebral nerve block(s) received an auricular neuromodulation device (NSS-2 Bridge, Masimo) following surgery. Participants were randomized to 5 days of electrical stimulation or sham in a double-masked fashion.

Results:

In the first 5 days, the median pain for those receiving active stimulation (n = 15) was 0 (interquartile range [IQR] = 0, 0.5] versus 1.5 (IQR = 0, 3.8) for the sham group (n = 15, P = 0.084). Concurrently, the median oxycodone use for active stimulation was 0 mg (IQR = 0, 2.5) compared to 0 mg (IQR = 0, 3) for the sham group (P = 0.905). Various secondary outcomes reached statistical significance, including maximum and average daily pain scores.

Conclusions:

This pilot study demonstrates that percutaneous auricular neuromodulation is a feasible approach for managing pain in ambulatory surgical procedures and shows potential as an effective analgesic following discharge. Considering its ease of application, absence of systemic side effects, and lack of significant complications, conducting a definitive clinical trial seems justified because the current study was underpowered, which possibly resulted in the lack of statistical significance for the primary outcome.Registry: Clinicaltrials.gov NCT05521516.

01 Dec 2025·NEUROPHARMACOLOGY

Evaluating the reinforcing properties of oxycodone and oxymorphone using intravenous drug self-administration in male rats

Article

Author: Fletcher, Paul J ; Rashvand, Mina ; Funk, Douglas ; Tyndale, Rachel F ; Miksys, Sharon

Oxycodone, a commonly abused opioid, and its metabolite oxymorphone are agonists at the μ-opioid receptor. While oxymorphone is more potent, and clinical data suggests a greater abuse liability, there is little data comparing them in preclinical models. We examined their reinforcing properties using the intravenous (IV) self-administration method. Male Wistar Han rats were implanted with IV catheters and trained to lever press for infusions of oxycodone and oxymorphone. Dose response curves were assessed using fixed ratio (FR) 1, FR3, FR5 and progressive ratio (PR) schedules. Responding was then extinguished and drug priming-induced reinstatement, a model of relapse, was assessed. Microdialysis was used to assess central concentrations of oxymorphone following IV oxycodone. Under FR1 schedules, in both oxycodone and oxymorphone self-administering rats, active lever pressing and infusions earned decreased with increasing dose, while intake increased, however the shape of the dose response curves differed. Oxymorphone, compared to oxycodone, exhibited a leftward shift in the dose-response curve, indicative of higher potency, but also a shallower slope and lower maximal active lever pressing and infusions. On the PR schedule, the highest breakpoint was observed for oxymorphone. Oxycodone (0.25 mg/kg) induced significant drug-priming reinstatement after extinction, while an equipotent dose of oxymorphone (0.025 mg/kg) approached significant reinstatement. After a bolus IV injection of oxycodone, oxymorphone was present in the cerebrospinal fluid at approximately 1/250th the concentration of oxycodone. These findings highlight distinct self-administration patterns between oxycodone, which is metabolized to oxymorphone in vivo, and oxymorphone itself, suggesting differences beyond potency at the μ-opioid receptor.

144

News (Medical) associated with Oxycodone

16 Oct 2025

·www.businesswire.com

Tris Pharma Announces Acceptance of New Review Article Highlighting Challenges of Treating Moderate-to-Severe Acute Pain with Currently Available Drugs

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced the acceptance of its company-sponsored, peer-reviewed article “The burden of acute pain in the U.S. in the wake of the opioid crisis” for publication in Frontiers in Pain Research. The paper presents critical statistics around the dilemma faced by healthcare professionals and their patients with the prescription of pain medications. Today, acute pain can often only be effectively managed by opioids, and failing to adequately manage severe acute pain substantially increases the risk of that pain becoming chronic. However, the need to utilize opioids must be balanced by their substantial risks of misuse, diversion, dependence and overdose, leaving many with untreated pain or risking it progressing and diminishing their quality of life. The need for safer, highly effective alternatives to today’s pain therapies has never been more urgent. Key highlights from the publication include: ~25% of patients who receive short-term opioid prescriptions experience euphoria 12% (8.3 million) of adult patients who are prescribed opioids end up misusing them; this risk increases among adolescents and teenagers Greater than 50% of patients addicted to heroin, fentanyl and other opioids started as pain patients who felt high (i.e., experienced euphoria) upon taking an opioid medication prescribed to them and went on to misuse the medication Roughly 80% of heroin and fentanyl users first misused prescription opioids before seeking out a greater high There are approximately 80,000 opioid-related overdose deaths per year and hundreds of thousands of non-fatal opioid overdoses, which often lead to significant utilization of healthcare resources and long-term medical complications The total attributable cost of acute and chronic pain in the U.S. was $923 billion in 2024 “Physicians today face significant challenges when treating acute pain. Despite the availability of non-opioid options, opioids are often necessary for effective acute pain relief,” said Charles Argoff, M.D., Albany Medical College and an author of the paper. “Opioids carry inherent risks that are associated with prescribing precautions; however, completely avoiding them in the setting of severe acute pain may result in suboptimal pain reduction, increasing the likelihood of the acute pain becoming chronic. This important publication highlights the urgent need for better therapeutics so that neither physicians nor patients have to choose between effective pain relief and risks detrimental to their quality of life, including addiction.” Details of the Publication Title: The burden of acute pain in the U.S. in the wake of the opioid crisis Authors: James C. Hackworth, Ph.D., Tris Pharma; Charles Argoff, M.D., Albany Medical College; John E. Schneider, Ph.D., Avalon Health Economics; Maggie Do Valle, MPH, Avalon Health Economics; David Fam, Pharm.D., Tris Pharma; Ema Offidani, Ph.D., Tris Pharma; Jim Potenziano, Ph.D., Tris Pharma Tris Pharma commissioned this research in support of its work developing cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist. About Acute Pain Acute pain affects millions of patients each year and is caused by injury, surgery, illness, trauma, burns or painful medical procedures, which can last up to three months, and typically resolves once the underlying cause is treated or healed. Moderate-to-severe acute pain can often only be effectively treated with opioid analgesics such as oxycodone, especially following joint replacements and other orthopedic procedures, invasive surgeries, and major traumas and burns. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain, addiction and disorders of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates such as cebranopadol. More information is available at www.trispharma.com and on LinkedIn @TrisPharma. About Cebranopadol Cebranopadol is a first-in-class investigational therapy that targets two key receptors, the nociceptin/orphanin FQ peptide (NOP) and µ-opioid peptide (MOP) receptors (a dual-NMR agonist), for the treatment of moderate-to-severe pain, as well as opioid use disorder (OUD). These receptors are partially homologous to each other, and they play both complementary and distinct roles to modulate pain biology pathways. Studied in over 33 clinical trials in more than 2,200 patients, cebranopadol’s profile has been well characterized in pain management studies. It has demonstrated positive clinical results in acute pain, chronic pain and diabetic neuropathic pain with a favorable safety profile. The FDA granted Fast Track Designation to cebranopadol for chronic low back pain, and if approved, it could become the first dual-NMR pain-relief therapy with the demonstrated ability to provide efficacy equivalent to opioids with less potential for misuse or risk of physical dependence, addiction or overdose. Cebranopadol’s novel mechanism of action has potential in treating patients with substance use disorders (SUDs). Tris plans to continue to evaluate cebranopadol’s potential to help patients break the cycle of opioid addiction. The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), has awarded Tris a five-year grant of up to $16.6 million to study cebranopadol’s potential to treat OUDs and SUDs.

Fast TrackClinical Result

17 Sep 2025

·www.einpresswire.com

Advancing Generic Drug Development: Translating Science to Approval - 09/21/2021

Advancing Generic Drug Development: Translating Science to Approval Keynote Address Janet Woodcock, MD Acting Commissioner of Food and Drugs Food and Drug Administration COVID-19 Impact on Generic Drug Regulation and Evaluation Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Alternative Bioequivalence Approaches for Data Analysis Due to COVID-19 Related Study Interruptions Quality Considerations in the Development of FDA Guidance “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency” Applications and Lessons Learned for Conducting Adaptive Designs on Generic Drug Development Q&A Panel Mitchell Frost, MD Acting Deputy Director Division of Therapeutic Performance II (DTP II) ORS | OGD | CDER Yuqing Gong, PhD Pharmacologist DQMM | ORS | OGD | CDER Gloria Huang, PhD Lead Chemist Division of Liquid-Based Products II (DLBP II) Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) | CDER Kairui (Kevin) Feng, PhD Staff Fellow DQMM | ORS | OGD | CDER Kimberly Witzmann, MD Acting Director Division of Clinical Review (DCR) Deputy Director Office of Safety and Clinical Evaluation (OSCE) | OGD | CDER Stella C. Grosser, PhD Director Division of Biometrics VIII Office of Biostatistics (OB) Office of Translational Sciences (OTS) | CDER Considerations in Assessing Generic Drug Products of Oral Dosage Forms Nasal Pharmacokinetic Study of Abuse-Deterrent Oxycodone HCl ER Products Following Insufflation of Physically Manipulated Products Advancement in the In-Vitro Evaluation of Abuse-Deterrent Formulations for Opioid Analgesics: Research and Assessment Perspectives Physiological Based Pharmacokinetic Modeling and Simulation Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products Safety Assessment of Flavors in Generic Drug Products Q&A Panel Saeid Raofi, MS Pharmacologist DTP II | ORS | OGD | CDER Manar Al-Ghabeish, PhD Staff Fellow Division of Product Quality Research (DPQR) OTR | OPQ | CDER Fang Wu, PhD Acting Team Lead DQMM | ORS | OGD | CDER Melanie Mueller, PharmD, PhD Team Lead Division of Pharmacology/Toxicology Review (DPTR) OSCE | OGD | CDER Xiaoming Xu, PhD Supervisory Chemist DPQR | OTR | OPQ | CDER Heather Boyce, PhD Acting Team Lead DTP II | ORS | OGD | CDER Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion Advances in Iron Colloid Products: Quality Considerations When Conducting Comparability Studies Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap Q&A Panel Wenlei Jiang, PhD Senior Science Advisor Immediate Office (IO) ORS | OGD | CDER Yiwei Li, PhD Branch Chief Division of Pharmaceutical Manufacturing IV (DPMAIV) Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ | CDER Bin Qin, PhD Staff Fellow DTP I | ORS | OGD | CDER Bruce Lerman, PhD Lead Pharmacologist DB I | OB | OGD | CDER Darby Kozak, PhD Deputy Director DTP I | ORS | OGD | CDER Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making Q&A Panel Chunsheng Zhao, PhD Bioequivalence Reviewer Division of Bioequivalence III (DB III) OB | OGD | CDER Poonam Chopra, PhD Review Chemist DLBP II | OLDP | OPQ | CDER Mingliang Tan, PhD Staff Fellow DQMM | ORS | OGD | CDER Yan Wang, PhD Acting Team Lead DTP I | ORS | OGD | CDER Asif Rasheed, PhD Senior Chemist DLBPI | OLDP | OPQ | CDER Kai Kwok, PhD Senior Pharmaceutical Quality Assessor DLBPII | OLDP | OPQ | CDER Advancing Generic Drug Development: Translation Science to Approval, Day One Closing Remarks Lei Zhang, PhD Deputy Director ORS | OGD | CDER Cutting Edge Science in Complex Generics Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs Model-Integrated Evidence for Bioequivalence Assessment of Complex Generic Drugs Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Formulations Q&A Panel Meng Hu, PhD Acting Team Lead DQMM | ORS | OGD | CDER Miyoung Yoon, PhD Acting Team Lead DQMM | ORS | OGD | CDER Huzeyfe Yilmaz, PhD Staff Fellow Division of Complex Drug Analysis (DCDA) OTR | OPQ | CDER Yan Wang, PhD Acting Team Lead DTP I | ORS | OGD | CDER Robert Lionberger, PhD Director ORS | OGD | CDER Daniel Willett, PhD Chemist DCDA | OTR | OPQ | CDER Complex Generics_Nasal and Inhalation Products Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies Approaches for studies interrupted due to COVID-19 for Nasal and Inhalation Products Demonstrating Bioequivalence with Inhalation Spray Drug Products Comparative Analyses for Generic Oral Inhalers Q&A Panel Susan Boc, PhD Scientific Researcher DTP I | ORS | OGD | CDER Vipra Kundoor, PhD Pharmacologist DB I | OB | OGD | CDER Sneha Dhapare, PhD Visiting Associate DTP I | ORS | OGD | CDER Michael Spagnola, MD Lead Physician DCSS | OSCE | OGD | CDER Bryan Newman, PhD Acting Team Lead DTP I | ORS | OGD | CDER Changning Guo, PhD Supervisory Chemist DCDA | OTR | OPQ | CDER Bing Cai, PhD Director DLBP I | OLPD | OPQ | CDER Complex Generics_Topical Products, Part 1 “No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products Use of Q3 Characterization Tests for Topical Semisolid Drug Products Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products Q&A Panel Megan Kelchen, PhD Pharmacologist DTP I | ORS | OGD | CDER Sam Raney, PhD Associate Director for Science IO | ORS | OGD | CDER Ahmed Zidan, PhD Senior Pharmacologist DPQR | OTR | OPQ | CDER Eleftheria Tsakalozou, PhD Staff Fellow DQMM | ORS | OGD | CDER Khondoker Alam, PhD Staff Fellow DQMM | ORS | OGD | CDER Markham Luke, MD, PhD Director DTP I | ORS | OGD | CDER Complex Generics_Topical Products, Part 2 Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products Theoretical Principles and Best Practices: In Vitro Release Test Theoretical Principles and Best Practices: In Vitro Permeation Test Q&A Panel Josephine Aimiuwu, PhD Pharmacologist DB II | OB | OGD | CDER Tannaz Ramezanli, PhD, PharmD Pharmacologist DTP I | ORS | OGD | CDER Priyanka Ghosh, PhD Acting Team Lead DTP I | ORS | OGD | CDER Markham Luke, MD, PhD Director DTP I | ORS | OGD | CDER Sam Raney, PhD Associate Director for Science IO | ORS | OGD | CDER Advancing Generic Drug Development: Translation Science to Approval, Day Two Closing Remarks Robert Lionberger, PhD Director ORS | OGD | CDER Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

04 Sep 2025

·ir.ensysce.com

Ensysce Biosciences Showcases Urgent Need for Safer Opioids at PAINWeek 2025 Symposium

~ Experts Spotlight TAAP™ and MPAR® as Next-Generation Solutions for Severe Pain ~ SAN DIEGO, CA / ACCESS Newswire / September 4, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today shared key takeaways from its standing-room-only symposium with about 400 attendees, "Pain Management, RE-Invented: A New Era for Analgesia", held September 3, 2025, at PAINWeek in Las Vegas-the world's largest pain management conference. Moderated by Dr. Lynn Kirkpatrick, CEO of Ensysce, the event brought together three leading authorities in pain medicine: Dr. Jessica McCoun, Principal Investigator at CenExel Atlanta, opened with strategies for controlling acute post-operative pain using multi-modal therapy to prevent chronification, the gradual transition from acute pain to chronic pain. She stressed the urgent need for powerful yet safer opioid options to restore patient function rapidly while reducing risk. Dr. Jeff Gudin, University of Miami Pain Center, examined the latest entrants to the analgesic toolbox-including NAV 1.8 inhibitors-and compared them to Ensysce's Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) technologies, which uniquely use the body's own chemistry to "switch on" pain relief with proper dosing and "switch off" opioid release in an overdose. Dr. William Schmidt, Ensysce's Chief Medical Officer, presented compelling data differentiating PF614 from other severe pain treatments, outlining the upcoming Phase 3 trial in acute post-surgical pain. He highlighted how TAAP™ and MPAR® could deliver superior analgesia while offering real-world overdose protection. Dr. Jessica McCoun, Principal Investigator at CenExel Atlanta, opened with strategies for controlling acute post-operative pain using multi-modal therapy to prevent chronification, the gradual transition from acute pain to chronic pain. She stressed the urgent need for powerful yet safer opioid options to restore patient function rapidly while reducing risk. Dr. Jeff Gudin, University of Miami Pain Center, examined the latest entrants to the analgesic toolbox-including NAV 1.8 inhibitors-and compared them to Ensysce's Trypsin Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) technologies, which uniquely use the body's own chemistry to "switch on" pain relief with proper dosing and "switch off" opioid release in an overdose. Dr. William Schmidt, Ensysce's Chief Medical Officer, presented compelling data differentiating PF614 from other severe pain treatments, outlining the upcoming Phase 3 trial in acute post-surgical pain. He highlighted how TAAP™ and MPAR® could deliver superior analgesia while offering real-world overdose protection. "This symposium marked our fourth major platform to showcase how Ensysce is reimagining opioid therapy," said Dr. Kirkpatrick. "PAINWeek brings together the most influential voices in pain medicine, and the response to our clinical vision was overwhelmingly positive, with feedback that our message describing the uniqueness of our technology to improve opioids was clear and compelling. We're committed to delivering the first opioid that not only treats severe pain effectively but also protects patients from the dangers of abuse and overdose." About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com. Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; continuation of government funding; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent quarterly report on Form 10-Q and current reports on Form 8-K, available free of charge at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact: Lynn Kirkpatrick, Ph.D. Chief Executive Officer (858) 263-4196 Ensysce Biosciences Investor Relations Contact: Shannon Devine MZ North America Main: 203-741-8811 ENSC@mzgroup.us SOURCE: Ensysce Biosciences Inc. Released September 4, 2025

Phase 3

100 Deals associated with Oxycodone

External Link

KEGG	Wiki	ATC	Drug Bank
D05312	Oxycodone	N02AA05	DB00497

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pain	China	Napp Pharmaceutical Holdings Ltd.	21 Jan 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	-	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Jan 2011
Neoplasms	Phase 3	-	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Jan 2011
Pain, Postoperative	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Mar 2010
Osteoarthritis	Phase 3	Belgium	Mundipharma Research GmbH & Co. KG	01 May 2009
Osteoarthritis	Phase 3	Czechia	Mundipharma Research GmbH & Co. KG	01 May 2009
Osteoarthritis	Phase 3	Finland	Mundipharma Research GmbH & Co. KG	01 May 2009
Osteoarthritis	Phase 3	Germany	Mundipharma Research GmbH & Co. KG	01 May 2009
Osteoarthritis	Phase 3	Hungary	Mundipharma Research GmbH & Co. KG	01 May 2009
Osteoarthritis	Phase 3	Spain	Mundipharma Research GmbH & Co. KG	01 May 2009
Acute Pain	Phase 2	United States	Ensysce Biosciences, Inc.	05 Oct 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05470465 (CTgov)	Phase 1	Hypercarbia	27	Placebo+Oxycodone (Treatment A: Placebo)	nnkvkhdcus(xfpjanyrds) = mezxmmlspc msqynqdyxn (besfnazlkl, vsuftqorcc - zczrjactgi) View more	-	22 May 2025
				Paroxetine+Oxycodone (Treatment B: Paroxetine)	nnkvkhdcus(xfpjanyrds) = ngogzhzfrq msqynqdyxn (besfnazlkl, airttvyjxc - iiiygazhnc) View more
NCT05924165 (CTgov)	Phase 4	Nephrolithiasis	90	5mg Oxycodone, Q6 PRN (Opioid Group)	rugblahgdd(ssuevznvfn) = xndohydqmk tcxgjdxjdi (qlqzwyvbmt, hhyoizeznl - ymnowsthli) View more	-	26 Mar 2025
				10mg Ketorolac, Q6 PRN (NSAID)	rugblahgdd(ssuevznvfn) = aeifvufmmf tcxgjdxjdi (qlqzwyvbmt, jpvxngslhy - cguzgeoixp) View more
PF614-MPAR-102 (Company_Website) Manual	Phase 1	Severe pain	-	PF614-MPAR	mvyshsszxk(ygimqctdtp) = MPAR product had a significantly lower (p=0.0019) total maximum blood concentration of oxycodone (Cmax) compared to PF614 alone, an indication of overdose protection. scrwsfbysm (ssaneztiia ) View more	Positive	22 Jan 2025
NCT04296396 (Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network, Pubmed \| Obstet Gynecol)	Phase 3	-	-	Opioid (IOPP with shared decision making)	hnfxmngybm(kucstwoiwv) = tzbagypyua dogbuitiet (vydhotpacj ) View more	Positive	01 Aug 2024
				Fixed quantity (20 tablets of 5 mg oxycodone)	hnfxmngybm(kucstwoiwv) = eestqoydwy dogbuitiet (vydhotpacj ) View more
PF614-201 (Biospace) Manual	Phase 2	-	-	PF614	bmmcssxhsl(ddcmdehxox) = demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels xsovanfgik (timqfasxvl )	Positive	14 Dec 2023
				placebo
WSC2023	Not Applicable	-	-	Opioid medications	kjiuqnseyw(raywfpxvpd) = taommvpkae jposmdbhpu (pumpwdftef )	-	23 Oct 2023
NCT05567354 (HAP, Corporate Publications) Manual	Phase 1	Chronic Pain	26	PF614	ydibcvkexz(itedticpqk): P-Value = 0.0133 View more	Positive	31 Oct 2022
				crushed oxycodone
SGO2022	Not Applicable	-	-	opioid (Open Surgery)	avptpfcyou(ueocseuwsj) = swyjjytinu euysgvuaka (kagrhcwuyw, 1 - 19)	-	01 Aug 2022
NCT04522206 (CTgov)	Phase 4	Spinal Injuries \| Pain, Postoperative	44	Pre-op Multimodal analgesia (MMA) regimen+oxycodone	dxbiduwguv(nwxctntofb) = nbqjfaafwo jnpjzjcycm (jikpfrnjtk, 2.6) View more	-	11 Jul 2022
NCT03996694 (Pubmed \| Pain Ther)	Phase 1	Respiration Disorders	19	Buprenorphine Buccal Film	mubcfjkcwp(alxvglmlum) = qiotkrixsa ntqpdtrcid (tjfbilobvw ) View more	Positive	07 May 2022
				Orally-administered Oxycodone	mubcfjkcwp(alxvglmlum) = udvukfaobx ntqpdtrcid (tjfbilobvw ) View more

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