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Last update 14 Apr 2025

Oxycodone

Last update 14 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 PainLow Back Pain+ [3]

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

380

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

7,478

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.

126

News (Medical) associated with Oxycodone

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

27 Mar 2025

·www.globenewswire.com

Collegium to Present Real-World Data at PainConnect 2025, the American Academy of Pain Medicine’s Annual Meeting

STOUGHTON, Mass., March 27, 2025 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it will present four posters highlighting real-world patient data from its differentiated pain portfolio at PainConnect 2025, the American Academy of Pain Medicine (AAPM)’s Annual Meeting, being held in Austin, TX, from April 3-6, 2025. Among these, the poster titled “Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II Opioids” has been selected as one of the top abstracts. This distinction includes recognition in AAPM’s Pain Medicine Journal, where the abstract will also be published. “We are excited to present four posters with important real-world data from our differentiated pain portfolio at PainConnect 2025 and are grateful to AAPM for selecting our poster at its meeting as a top abstract. We expect these collective data to offer meaningful information for healthcare professionals who treat people with pain,” said Thomas Smith, M.D., Chief Medical Officer. “As the leader in responsible pain management, we also look forward to highlighting important aspects of our medicines as part of our unwavering commitment to the highest ethical standards.” The following posters will be presented to attendees on Friday, April 4 at the times listed below. Poster Title:Opioid Abuse Deterrent Formulations: Evaluation of Nonmedical Use of Other Prescription Opioid Substances and Routes of Administration in Adults Evaluated for Substance Use Treatment with the Addiction Severity Index-Multimedia Version (ASI-MV®)Authors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:00 – 11:05 a.m. CT Poster Title:Evaluating the Abuse Profile of Opioid Pain Medications by Their Controlled Substance Act Designated Schedule: A Systematic Review of Real-World EvidenceAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:05 – 11:10 a.m. CT Poster Title:Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II OpioidsAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Kaitlin Hartlage, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:10 – 11:15 a.m. CT Poster Title:Clinical Outcomes Translated to Healthcare Costs: Comparison of Buprenorphine Pain Medications with Schedule II Extended-Release OpioidsAuthors:Jody L. Green, Ph.D.; Taryn Dailey-Govoni, MPH; Kaitlin Hartlage, MPH; Suzanne K. Vosburg, Ph.D.Presentation Date and Time:Friday, April 4 from 11:15 – 11:20 a.m. CT BELBUCA® (buprenorphine buccal film) CIII is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.Not for use to treat pain that is not around-the-clock. IMPORTANT SAFETY INFORMATION about BELBUCA® WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTSAddiction, Abuse, and MisuseBELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA, and monitor regularly for these behaviors and conditions.Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program,counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and poses a significant risk of overdose and death.Accidental ExposureAccidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine.Neonatal Opioid Withdrawal SyndromeProlonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Important information about BELBUCA: Get emergency help or call 911 right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law.Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not use BELBUCA if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage or have narrowing of the stomach or intestines. Before taking BELBUCA, tell your healthcare provider if you have a history of: head injury, seizuresheart rhythm problems (long QT syndrome)liver, kidney, thyroid problemstooth problems, including a history of cavitiespancreas or gallbladder problemsproblems urinatingabuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby.living in a household where there are small children or someone who has abused street or prescription drugs.taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death. When taking BELBUCA: Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.See the detailed Instructions for Use for information about how to apply BELBUCA.Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA.Avoid touching or moving the buccal film with your tongue or fingers.Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.Call your healthcare provider if the dose you are using does not control your pain.Do not stop using BELBUCA without talking to your healthcare provider.Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging,and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While using BELBUCA DO NOT: Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die. The possible side effects of BELBUCA are: nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of BELBUCA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. Please see full Prescribing Information, including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide or speak to your healthcare provider if you have questions about BELBUCA. INDICATIONS AND USAGE Xtampza® ER (oxycodone) is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them.A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.Not for use to treat pain that is not around-the-clock. IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSAddiction, Abuse, and MisuseXtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program,counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.Neonatal Opioid Withdrawal SyndromeProlonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.Risks From Concomitant Use With Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Xtampza ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Important information about Xtampza ER: Get emergency help or call 911 right away if you take too much Xtampza ER (overdose). When you first start taking Xtampza ER, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an overdose.Taking Xtampza ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone else your Xtampza ER. They could die from taking it. Selling or giving away Xtampza ER is against the law.Store Xtampza ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Xtampza ER if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage, or have narrowing of the stomach or intestines. Before taking Xtampza ER, tell your healthcare provider if you have a history of: head injury, seizuresliver, kidney, thyroid problemsproblems urinatingpancreas or gallbladder problemsabuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of Xtampza ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.breastfeeding. Not recommended during treatment with Xtampza ER. It may harm your baby.living in a household where there are small children or someone who has abused street or prescription drugs.taking prescription or over-the counter medicines, vitamins, or herbal supplements. Taking Xtampza ER with certain other medicines can cause serious side effects that could lead to death. When taking Xtampza ER: Do not change your dose. Take Xtampza ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.If you cannot swallow Xtampza ER capsules, see the detailed Instructions for Use in the Medication Guide.Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.Swallow Xtampza ER whole. Do not snort or inject Xtampza ER because this may cause you to overdose and die.The contents of the Xtampza ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.Call your healthcare provider if the dose you are taking does not control your pain.Do not stop taking Xtampza ER without talking to your healthcare provider.Dispose of expired, unwanted or unused Xtampza ER by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking Xtampza ER, DO NOT: Drive or operate heavy machinery, until you know how Xtampza ER affects you. Xtampza ER can make you sleepy, dizzy, or light-headed.Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Xtampza ER may cause you to overdose and die. The possible side effects of Xtampza ER are: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of Xtampza ER. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov. See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at XtampzaER.com/PI. Speak to your healthcare provider if you have questions about Xtampza ER. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and recently acquired Jornay PM, a treatment for ADHD, establishing a presence in neuropsychiatry. Collegium’s strategy includes growing its commercial portfolio, with Jornay PM as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to realize the anticipated benefits associated with the acquisition of Ironshore; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency (DEA), compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contacts:Ian KarpVice President, Investor Relationsir@collegiumpharma.com Danielle JesseDirector, Investor Relationsir@collegiumpharma.com Media Contact:Cheryl WheelerHead of Corporate Communicationscommunications@collegiumpharma.com

100 Deals associated with Oxycodone

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KEGG	Wiki	ATC	Drug Bank
D05312	Oxycodone	N02AA05	DB00497

R&D Status

Approved

10 top approved records.

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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
Low Back Pain	Phase 3	United States	Collegium Pharmaceutical, Inc.	01 Aug 2012
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

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05924165 (CTgov)	Phase 4	Nephrolithiasis	90	5mg Oxycodone, Q6 PRN (Opioid Group)	jirlovcoiu(iobimxytkc) = lzrwjcamng hbxfpndkgt (wjrduphkgj, iufffbggze - zprkhsoijr) View more	-	26 Mar 2025
				10mg Ketorolac, Q6 PRN (NSAID)	jirlovcoiu(iobimxytkc) = vxvvscvizx hbxfpndkgt (wjrduphkgj, ufwyjtmurm - nlufjrbdmn) View more
PF614-MPAR-102 (Company_Website) Manual	Phase 1	Severe pain	-	PF614-MPAR	mkfeelpris(saarhuqufd) = 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. vupiyeaxgz (dtpubakfgc ) View more	Positive	22 Jan 2025
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	xisyrvqelu(otzvioqwgy) = cjcyqbecqc qumdppgjpk (bkrhijocvf, ykziuluhlf - ixxvrppmhi) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	xisyrvqelu(otzvioqwgy) = mqinnixjhk qumdppgjpk (bkrhijocvf, iecsbxmcji - xwwjcyyzdv) View more
NCT04791761 (CTgov)	Phase 1/2	Pain, Postoperative	73	Opioid disposal education+Acetaminophen+Ibuprofen+Oxycodone (Opioid Pain Control)	kwhizcgkqx(zbbdepzdkf) = mkjsuhnexk htfiecpenb (kwaputxtmq, ruimzvwoej - snwsruezam) View more	-	16 Aug 2024
				Acetaminophen+Ibuprofen (Non-opioid Pain Control)	kwhizcgkqx(zbbdepzdkf) = egvitaujov htfiecpenb (kwaputxtmq, dnjkmkgzzg - nbejixohtt) 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)	kgwupqbunv(tywvwxqrrs) = wfkkljkzwy lrbadtfsim (xvljhvxube ) View more	Positive	01 Aug 2024
				Fixed quantity (20 tablets of 5 mg oxycodone)	kgwupqbunv(tywvwxqrrs) = fgqqemmfvf lrbadtfsim (xvljhvxube ) View more
NCT04015908 (CTgov)	Phase 4	-	100	Pregabalin+Acetaminophen+Celecoxib+Oxycodone (Multi-modal)	ebvkrankgf(wrerxfofsk) = klewpygojq uutgipvgyd (qhhaklmwuy, qdrgifqtrd - jqgfzcsxoo) View more	-	08 Jul 2024
				Percocet (Control)	ebvkrankgf(wrerxfofsk) = ticekwcwft uutgipvgyd (qhhaklmwuy, osgaiorodt - cmfcqidytb) View more
PF614-201 (Biospace) Manual	Phase 2	-	-	PF614	xlgzqrhagc(tcckafnwhp) = demonstrated time-to-efficacy onset for the analgesia effect and significant decrease of pain intensity versus placebo of PF614 at two different dose levels sflgmmketr (yjcxjsksjh )	Positive	14 Dec 2023
				placebo
WSC2023	Not Applicable	-	-	Opioid medications	ufzfcmtrqn(yemlwhdxzr) = dbzaequykv dtuigpuoql (pvwaefwtwj )	-	23 Oct 2023
NCT04285853 (CTgov)	Phase 4	Anterior Cruciate Ligament Injuries	98	Oxycodone (Oxycodone Arm)	lfwbabinac(zputcdgmrf) = urxoookizu yawlezhggm (dcglujnahc, fbwbwnbilt - bmhcmkjmjb) View more	-	11 Oct 2023
				Placebo oral tablet (Placebo Arm)	lfwbabinac(zputcdgmrf) = ssyculvbmy yawlezhggm (dcglujnahc, voexljnqka - vrdwqnwagb) View more

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