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Last update 17 Apr 2025

Oxycodone

Last update 17 Apr 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+ [1]

Inactive Indication

Cancer PainChronic PainNeoplasms+ [2]

Originator Organization

Collegium Pharmaceutical, Inc.

Active Organization

Ensysce Biosciences, Inc.Napp Pharmaceutical Holdings Ltd.

Collegium Pharmaceutical, Inc.

Inactive Organization

Mundipharma Research GmbH & Co. KG

Beijing Mengdi Pharmaceutical Co. Ltd.Grunenthal SA

Drug Highest PhaseApproved

First Approval Date

China (21 Jan 2004),

Pain

RegulationFast Track (United States), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC18H21NO4

InChIKeyBRUQQQPBMZOVGD-XFKAJCMBSA-N

CAS Registry76-42-6

379

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.

NCT06721988

/ Not yet recruitingNot ApplicableIIT

Exploring the Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Pain in Adult Patients Underwent Laparoscopic-assisted Abdominal Major Surgery

The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. The main question it aims to answer is:
• Does administration of oxycodone before surgical incision reduce the occurrence of chronic pain or relieve the chronic pain symptoms 3 months after the operation? Researchers will compare oxycodone + parecoxib sodium to placebo + parecoxib sodium combinations to see if oxycodone works to reduce the chronification of acute postoperative pain.
Participants will:
* Take oxycodone + parecoxib sodium or placebo + parecoxib sodium combinations before the surgical incision
* Cooperate with the follow-up staffs and complete some checkups or tests within 3 months after the operation.

Start Date01 Jan 2025

Sponsor / Collaborator

Tongji Hospital Tongji Medical College of HUST

[+2]

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

100 Clinical Results associated with Oxycodone

100 Translational Medicine associated with Oxycodone

100 Patents (Medical) associated with Oxycodone

7,486

Literatures (Medical) associated with Oxycodone

01 Dec 2025·European Journal of Trauma and Emergency Surgery

Pre-injury narcotic drug use in isolated severe traumatic brain injury: effect on outcomes

Article

Author: Demetriades, Demetrios ; Jakob, Dominik Andreas ; Takahashi, Kyosuke ; Yamaguchi, Keishi ; Matsushima, Kazuhide ; Abe, Takeru

PURPOSE:

The aim of this study was to explore the association between pre-injury narcotic drug use (opioids, methadone, and/or oxycodone) and outcomes in isolated severe traumatic brain injury (TBI) patients.

METHODS:

ACS TQIP study included adult trauma patients (≥ 16 years) with complete drug and alcohol screening. Isolated severe TBI was defined as head trauma with AIS 3-5 and without significant extracranial trauma. Exact matching was used to compare patients with isolated pre-injury narcotic drug use to those with no illicit drug or alcohol use. Patients were matched 1:1 based on the following matching criteria: age, gender, mechanism of injury, Injury Severity Score, systolic blood pressure, head AIS, and comorbidities.

RESULTS:

Of 1,846,630 patients, 141,058 had isolated severe head injuries with complete drug and alcohol screenings. After exact matching, 1,560 patients in each group were analyzed. There were no significant differences in hospital mortality, craniectomy rates, complication rates, or length of hospital stay. Patients that tested positive for narcotics had lower rates of mechanical ventilation (16.5% vs. 25.3%, p < 0.01) and shorter ICU stays [3 (2-4) days vs. 3 (2-6) days; p < 0.01].

CONCLUSION:

Pre-injury narcotic drug use in isolated severe TBI is not associates with adverse outcomes. Further research is needed to understand the biochemical and physiological effects of narcotic drugs on TBI outcomes.

01 Sep 2025·Journal of Orthopaedics

Tramadol-based multimodal pain protocols after arthroscopic rotator cuff repair are similarly effective as oxycodone-based protocols with fewer morphine milligram equivalents prescribed and lower risk of refills

Article

Author: Austin, Luke S ; Riebesell, Samantha A ; Mehta, Nabil ; DeBernardis, Dennis A ; Baker, William F

Background:

Tramadol is a synthetic opioid prescribed to control postoperative pain while mitigating the harmful effects of stronger opioids, such as oxycodone. However, it is unknown whether tramadol can serve as an adequate substitute for oxycodone following shoulder surgery. Therefore, the primary purpose of this study was to compare early postoperative pain scores and prescribed narcotic between patients receiving tramadol and oxycodone after arthroscopic rotator cuff repair (ARCR). The secondary purpose was to identify risk factors related to experiencing increased postoperative pain or requiring increased postoperative prescriptions.

Methods:

A retrospective cohort study was performed evaluating 58 patients receiving a tramadol-based pain management protocol and 103 patients receiving an oxycodone-based protocol after ARCR. VAS pain scores were obtained preoperatively and at 2 weeks, 6 weeks, and 3 months postoperatively. The change in VAS score from preoperative to 3-month follow-up was calculated. Total milligram morphine equivalent (MMEs) prescribed, number and timing of refills, and the proportion of patients failing the tramadol protocol who required oxycodone were recorded. Multivariate regression analysis was performed to determine risk factors for having higher postoperative pain scores and requiring an increased number of prescriptions.

Results:

The average total number of MMEs prescribed for patients who received oxycodone was over 8 times greater than for patients who received tramadol (993 vs. 120 MMEs). Both groups demonstrated improvements in pain scores at all time points. Patients receiving tramadol had a greater change in VAS score from pre to postoperative at all timepoints. Patients who were prescribed oxycodone received a greater number of refills and were 2.7 times more likely to need a refill within 3 months than those receiving tramadol. Only 4 patients (6.9 %) receiving tramadol required oxycodone within 3 months of surgery.

Conclusion:

As part of a multimodal protocol, tramadol provides equivalent pain relief after ARCR compared to oxycodone while requiring fewer MMEs. Patients prescribed oxycodone exhibit a smaller magnitude of improvement in VAS pain and require more refills than those prescribed tramadol. Our findings can be used to improve opioid prescription practices to reduce dependency and over prescription of narcotics.

01 Jul 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Pharmacokinetics of oxycodone in rats: Influence of micronized magnesium lactate on oxycodone bioavailability

Article

Author: Ofiara, Karol ; Szterk, Arkadiusz ; Flis, Sylwia ; Hijano, Daniel Ortega ; Strus, Bartosz

This article presents studies on the pharmacokinetics of oxycodone hydrochloride and the influence of micronized magnesium lactate on its bioavailability and pharmacokinetic parameters. Two methods, HPLC-DAD, and HPLC-MS/MS, were developed and validated to investigate the content of oxycodone hydrochloride in the developed medicinal products and, oxymorphone in blood serum using an isotopic dilution method. The aim was to develop a novel pharmaceutical formulation combining oxycodone hydrochloride with Mg²⁺, which could increase the efficacy of analgesia while reducing the opioid dose. Experiments were conducted on Wistar rats, analyzing the changes in plasma concentrations of oxycodone hydrochloride and its metabolite oxymorphone after intragastric administration of two formulations: one containing oxycodone hydrochloride alone and the other with the addition of micronized magnesium lactate. The results indicate that the presence of Mg²⁺ decrease the bioavailability of oxycodone, which is related to chemical reactions between the formulation components. This phenomenon has been overlooked by other researchers determining the interaction of Mg²⁺ with opioids in enhancing the antinociceptive effect of opioids.

127

News (Medical) associated with Oxycodone

15 Apr 2025

·ir.ensysce.com

Ensysce Biosciences Announces Positive Data from Opioid Overdose Protection Study

~ Additional Evidence of PF614-MPAR Overdose Protection after Completion of Part 1 of Clinical Study ~ SAN DIEGO, CA / ACCESS Newswire / April 15, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced completion of Part 1 of its second clinical trial to evaluate PF614-MPAR for overdose protection. PF614-MPAR-102 demonstrated that the combined Ensysce TAAPTM and MPAR® technologies can deliver strong relief for severe pain yet protect from the risk of excessive doses when consumed accidentally or deliberately. Part 1 of this second study of PF614-MPAR overdose protection confirmed that a 100 mg dosage of PF614-MPAR delivers oxycodone to treat severe pain and provides overdose protection when a greater-than-prescribed dose is consumed. Subjects were studied as their own control and received up to five 100 mg doses of the overdose-protected PF614-MPAR versus the unprotected PF614. The data showed that the maximum amount of oxycodone released from PF614-MPAR, when three or more doses were taken at one time (Cmax) was reduced compared to that released following the consumption of same amount of PF614 alone, evidence of overdose protection. When five doses of PF614-MPAR were administered, overdose protection was appropriately greater than that observed from three dose units. Additionally, safety data from the trial showed that there were no unexpected adverse events from either PF614 or PF614-MPAR. We believe this data, combined with that from a previous study, PF614-MPAR-101, demonstrates overdose protection across the full dosage range of PF614-MPAR planned for commercialization. This complete analysis will be discussed with the FDA in an upcoming meeting focusing on the full development plans for PF614-MPAR. The trial will now continue to enroll Part 2 to examine potential food effect and Part 3 to evaluate repeat dosing of PF614 vs. PF614-MPAR. The aggregate data will allow the Company to focus on perfecting a final drug product to move into commercialization. Dr. Bill Schmidt, Chief Medical Officer of Ensysce, commented, "These clinical data demonstrate that MPAR® is a vital tool to limit overdoses from prescription medications. Our initial study demonstrated the unique overdose protection built into PF614-MPAR, which is the only opioid product to have been granted FDA's Breakthrough Therapy designation. Our goal of bringing PF614-MPAR and a new generation of safer analgesics to the market to alleviate suffering from severe pain is now closer to the finish line." Dr. Lynn Kirkpatrick, CEO of Ensysce, added, "Each phase of our MPAR related clinical studies thus far have provided highly encouraging data supporting the safety features of PF614 and PF614-MPAR that other opioids don't have. We are continuing to quickly execute the final stages of this study with Quotient Sciences and their Translational Pharmaceutics® platform, and we are working with a commercial manufacturing partner to prepare this unique product for the market. We look forward to productive discussions with the FDA to establish our path to registration for the first overdose-protected opioid." PF614-MPAR 102 Clinical Study Description Clinical study PF614-MPAR-102, ‘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 of Immediate Release Solution and Extended Release Capsule Formulations (PF614-MPAR) in Healthy Subjects,' was designed to evaluate the full dosage range of PF614-MPAR, study potential food effects, and to conduct a multiple ascending dose study with the final PF614-MPAR combination. 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 (TAAPTM) 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, 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; 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-K and current reports on Form 8-K, which are 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 Released April 15, 2025

Breakthrough TherapyClinical ResultClinical Study

10 Apr 2025

·www.prnewswire.com

Newborn Brains Are Smaller When Exposed to Opioids During Gestation

An important "first dive" into data from the 4-site Outcomes of Babies with Opioid Exposure (OBOE) study features a Cincinnati Children's expert as co-first author CINCINNATI, April 10, 2025 /PRNewswire/ -- When pregnant women take opioids during pregnancy, even opioids such as buprenorphine or methadone to treat opioid use disorder, the developing brains of their children can be significantly affected, according to a study published April 7, 2025, in JAMA Pediatrics. Continue Reading Antenatal opioid exposure is associated with smaller neonatal brain volumes, with varying impact depending on the type and number of exposures, according to research published in JAMA Pediatrics. Stephanie Merhar, MD, MS, at Cincinnati Children's was first co-author. Total brain volume was nearly 5% smaller among 173 newborns with antenatal opioid exposure compared to 96 unexposed newborns, based on magnetic resonance imaging (MRI) scans. More specifically, reduced volumes among opioid-exposed newborns occurred in cortical gray matter, deep gray matter, white matter, cerebellum, brainstem, and the right and left amygdala. There were notable differences in the location and scale of the effects, which varied depending on the type of opioid involved, and whether other drugs were also taken during pregnancy. "We have known for a while that children exposed to opioids during pregnancy are at risk of later developmental and behavioral problems, but it was hard to know whether that was due to the opioids themselves or other factors such as other exposures or lower birth weight," says co-first author Stephanie Merhar, MD, MS, a neonatologist at Cincinnati Children's. "This study was launched because we needed a large study where we were able to control for things like nicotine exposure and birth weight. Our next step is to follow the children in the study to see whether having smaller brain volumes in the newborn period affects later development and behavior." The double-threat opioids pose to mothers and children Nearly 1 in 12 newborns in the United States in 2020 – or about 300,000 infants – were exposed to alcohol, opioids, marijuana or cocaine before they were born, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Prenatal substance exposure in rural areas often exceeds overall national averages. Opioids include illegal drugs like heroin and fentanyl, prescription drugs like oxycodone and hydrocodone, and medications for opioid use disorder like buprenorphine and methadone. Opioid use often goes hand in hand with smoking and use of other substances such as alcohol and marijuana. This study compared newborns born to mothers who took opioids only and newborns born to mothers who used other substances as well as opioids. Newborns exposed to opioids plus other substances had smaller brain volumes in more regions compared to those exposed to opioids only. The most common opioids among participants in the new study were buprenorphine (68.8%) and methadone (26%). Both of these opioids are routinely used to treat opioid use disorder (OUD) and are both recommended for treatment of OUD during pregnancy by the American College of Obstetricians and Gynecologists. "We know that buprenorphine and methadone are life-saving medications for women with OUD," Merhar says. "We don't want to imply that women with OUD should wean off these medications, but we agree with the ACOG recommendation for more research on medically supervised withdrawal in pregnant women." The study was praised in an accompanying editorial penned by Nethra Madurai, MD, and Lauren Jantzie, PhD, both of Johns Hopkins University School of Medicine. Other small studies have shown fetal brain changes caused by opioids. But this multi-center study is the first to be large enough to convincingly distinguish effects linked to opioids versus confounding factors such as maternal smoking, birth weight, education levels. The study authors "present compelling evidence of the direct effects of opioids on the developing brain," the editorial states. "Given the prospective design of the trial, they account for other postnatal factors…allowing us to dispel previous uncertainty surrounding the direct impacts of opioids on the brain vs the confounding effects of other environmental factors." What's next? Having more precise information about the affected parts of the brain could allow scientists to focus on interventions to support healthy brain development for children born after opioid exposure. "Indeed, we must shift our focus beyond the initial withdrawal symptoms associated with POE [prenatal opioid exposure] if we are to improve the lifelong health and well-being of infants and children impacted by the opioid epidemic," the editorial states. Read more about Merhar's research related to opioid exposure: 'Eat, Sleep, Console' Approach Slashes ICU Stays for Opioid-Exposed Newborns In Utero Opioid Exposure Impacts Fetal Brain Size and Development $8M Grant Funds Long-Term Opioid Exposure Study SOURCE Cincinnati Children's Hospital Medical Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

07 Apr 2025

·www.prnewswire.com

Elysium Therapeutics Announces Development of Overdose Rescue Technology Specifically Designed for Oral Fentanyl

Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) targets an unmet challenge in the illicit opioid crisis as current rescue medications are not designed for synthetic opioids, including oral fentanyl. LYONS, Colo., April 7, 2025 /PRNewswire/ -- Elysium Therapeutics, an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral opioids, including synthetic opioids like fentanyl, announced its plan to accelerate development of its Synthetic Opioid Overdose Prevention and Reversal (SOOPR™) technology. The company has completed in vivo proof-of-concept studies and expects to file an Investigational New Drug (IND) application in 2026. SOOPR is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone prodrug formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 to 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. "Fentanyl overdoses often require very high, or repeated, doses of short-acting opioid antagonists to effect a successful rescue," said Greg Sturmer, Co-Founder and CEO of Elysium Therapeutics. "Unfortunately, many who overdose face a rapid recurrence of symptoms, known as re-narcotization, which can lead to respiratory depression and increase the likelihood of hypoxic brain injury or death. SOOPR is designed to address this situation, and Elysium is now focused on advancing its development as a potential first-ever, faster-onset, longer-acting opioid rescue therapy specifically intended to treat fentanyl overdose." Currently approved short-acting opioid antagonists like Narcan and Opvee® were designed to effectively counteract overdoses from opioids such as heroin and oxycodone. However, these rescue agents are frequently ineffective in the management of synthetic opioid overdoses1, with 20 to 45% of overdose victims initially rescued with naloxone experiencing a re-narcotization event. According to reports from multiple state-affiliated health agencies, 31 to 39% of fentanyl overdose decedents had been administered naloxone.2 Data from in vivo proof-of-concept studies of SOOPR demonstrated a more rapid onset of action versus naloxone (Narcan) and a significantly longer duration of action. This profile is especially useful in counteracting oral fentanyl overdoses associated with prolonged fentanyl absorption and exposure that often outlast the short-acting profile of Narcan. "In designing SOOPR, Elysium recognized that synthetic opioids – now the number one killer of adults aged 18 to 45 in the U.S. – are particularly lethal," said Tom Jenkins, Ph.D., Co-Founder and Chief Scientific Officer of Elysium Therapeutics. "Patients initially treated with a rapid-acting, long-duration reversal agent, such as SOOPR, are expected to have less risk of hypoxic brain injury, cardiovascular events, re-narcotization, and death. Further, rescue interventions with SOOPR are expected to require less intensive monitoring in both the ambulance and emergency department and increase the likelihood of survival. Additionally, SOOPR is designed to be delivered by intramuscular injection, either using a pre-filled syringe or autoinjector, which has been demonstrated to be more rapid and predictable than intranasal delivery in urgent settings, where every second counts." "In addition to preventing overdose deaths from recreational, illicit use, the Department of Defense (DOD) has made clear the importance of improving opioid overdose rescue as a needed medical countermeasure," added Sturmer. "The DOD reported that the availability of synthetic opioids, such as fentanyl and its derivatives, represents a significant threat as a chemical weapon, which could be easily disseminated as a weapon of mass destruction into air, water or food supplies, putting countless lives at risk. We look forward to working with defense and government organizations as we develop SOOPR as a tool to prevent injury and death in these worrisome scenarios." About SOOPR™ (Synthetic Opioid Overdose Prevention and Rescue) SOOPR (Synthetic Opioid Overdose Prevention and Reversal) is a rapid-onset, long-acting rescue agent specifically designed to address overdose from synthetic opioids, including oral fentanyl. SOOPR utilizes a proprietary long-acting naloxone reversal formulation with faster onset kinetics versus Narcan® delivered via long-acting injection (LAI) technology. The technology is designed to rapidly restore respiration and provide 18 – 24 hours of effective opioid blockade to minimize the risk of re-narcotization, while also providing protection from same-day re-use of opioids. SOOPR has been endorsed by first responders and OUD treatment professionals as the effective solution urgently needed to address the global opioid overdose epidemic. About Elysium Therapeutics Elysium is an emerging biopharmaceutical company developing treatments specifically designed to rescue and reverse overdoses caused by oral synthetic opioids, including fentanyl. Elysium is working to establish new standards of safety in the opioid industry by developing SMART™ (Safer Medicines Alleviate Risks and Trauma) products, first- and best-in-class medicines that address the limitations and dangers associated with opioids and overdose rescue agents to reduce suffering from opioid-use disorder, opioid overdose, and acute pain. Elysium's lead technology, SOOPR™ (Synthetic Opioid Overdose Prevention and Reversal), is a long-acting opioid antagonist specifically designed to address oral synthetic opioid, including fentanyl, overdose. Tens of thousands of unnecessary overdose deaths each year exemplifies the critical shortcomings of currently available rescue agents, including naloxone and nalmefene. In addition, Elysium is developing oral-overdose protected (O2P™) hydrocodone for the treatment of moderate-to-severe acute pain. For more information, please visit . 1 Rachael Rzasa Lynn and JL Galinkin Ther Adv Drug Saf 2018, Vol. 9(1) 63–88 (Also see footnotes 8, 9, and 10 for additional discussion). 2 Watson, W.A., Steele, M.T., Muelleman, R.L., Rush, M.D., 1998. Opioid toxicity recurrence after an initial response to naloxone. J. Toxicol. Clin. Toxicol. 36 (1-2), 11–17. . SOURCE Elysium Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

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.

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Indication	Highest Phase	Country/Location	Organization	Date
Tumor pain	Phase 3	Germany	Mundipharma Research GmbH & Co. KG	01 Nov 2014
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05924165 (CTgov)	Phase 4	Nephrolithiasis	90	5mg Oxycodone, Q6 PRN (Opioid Group)	ispvscwfgw(qyoojluwus) = wqsyalbmoj jhhcmclthr (jbscoqbvhq, mwcijbnaxx - yhspkhcwes) View more	-	26 Mar 2025
				10mg Ketorolac, Q6 PRN (NSAID)	ispvscwfgw(qyoojluwus) = qgjjorssjl jhhcmclthr (jbscoqbvhq, rqzcjjsgia - aoulhhxyqq) View more
PF614-MPAR-102 (Company_Website) Manual	Phase 1	Severe pain	-	PF614-MPAR	obmefgxfff(jhtzccwisq) = 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. hfwcrswcpe (pqiqflgxbz ) View more	Positive	22 Jan 2025
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	edyvcdhzfw(tqwcfqzlea) = aumxfcfjkz lzpzrnlspv (nyiqvveygg, jwygwwagrn - infthlsabo) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	edyvcdhzfw(tqwcfqzlea) = vjjnocucts lzpzrnlspv (nyiqvveygg, yfpxrrpuyj - qlrkxiohue) View more
NCT04791761 (CTgov)	Phase 1/2	Pain, Postoperative	73	Opioid disposal education+Acetaminophen+Ibuprofen+Oxycodone (Opioid Pain Control)	atogcpoojz(mqihlowoeo) = ceagaesnjt qrkuxucyfb (kupqohunpn, zqzzekesky - sfzjoypaqt) View more	-	16 Aug 2024
				Acetaminophen+Ibuprofen (Non-opioid Pain Control)	atogcpoojz(mqihlowoeo) = bwatinddcm qrkuxucyfb (kupqohunpn, pjcptnozln - jpzeckptdf) View more
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)	yxzclgvvya(niapczucjh) = zepukqxjas cptokkczsb (jifizpcrxs ) View more	Positive	01 Aug 2024
				Fixed quantity (20 tablets of 5 mg oxycodone)	yxzclgvvya(niapczucjh) = sttdudqabn cptokkczsb (jifizpcrxs ) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Celecoxib+Oxycodone (Multi-modal)	dztxhuavnf(ehmbodqyzm) = fgkwqobhlt eagrzdrxsa (fnxkwsrjox, skuyrocqjy - amjxyopmve) View more	-	08 Jul 2024
				Percocet (Control)	dztxhuavnf(ehmbodqyzm) = kivjyqikpo eagrzdrxsa (fnxkwsrjox, ubghepngcl - oywgelsbym) View more
PF614-201 (Biospace) Manual	Phase 2	-	-	PF614	sfsclchzyk(egpdlbtakb) = demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels taetaecicl (qgoaniunbs )	Positive	14 Dec 2023
				placebo
WSC2023	Not Applicable	-	-	Opioid medications	weglhnonmf(ffkvuhuezu) = cjdgbamaui rjysrgyolw (vhpauzpjqh )	-	23 Oct 2023
NCT04285853 (CTgov)	Phase 4	Anterior Cruciate Ligament Injuries	98	Oxycodone (Oxycodone Arm)	ltvwfjcgqe(gyidqgvzcs) = efsuuadruf kpcqfueycj (zbsewpmfyh, iiptxfkjio - qrgfdbtbep) View more	-	11 Oct 2023
				Placebo oral tablet (Placebo Arm)	ltvwfjcgqe(gyidqgvzcs) = yhcnpyhzea kpcqfueycj (zbsewpmfyh, dfmvndonvb - iezuixmory) View more

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