oxycodone/naloxone ER / Generic mfg. - LARVOL DELTA

Oxycodone/naloxone PR versus oxycodone PR in advanced cancer: A multi-centre randomised trial (ENhANCE trial). (PubMed, Palliat Med) - "OXN PR is non-inferior to Oxy PR in analgesic effectiveness and superior in reducing constipation. These results indicate OXN PR as the choice of opioid preparation in advanced cancer. Future studies may explore adding naloxone to other slow and immediate release opioid preparations."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Oncology • Pain • Palliative care

Pharmacokinetics and Safety of Oxycodone/Naloxone Prolonged-Release Tablets in Chinese Patients with Chronic Pain. (PubMed, Drug Des Devel Ther) - "No serious adverse events were reported. The study showed the pharmacokinetic profiles, as well as good safety and tolerability of 40 mg/20 mg oxycodone/naloxone prolonged-release tablets in Chinese subjects, supporting further development and application in the Chinese population."

Clinical • Journal • PK/PD data • Pain

Prolonged opioid use after single-level lumbar spinal fusion surgery in a Belgian population: a multicentric observational study. (PubMed, Eur Spine J) - "1 in 3 patients undergoing single-level lumbar spinal fusion surgery is at risk for prolonged opioid use. The study underscores the importance of tailored pain management strategies, particularly given the rising prevalence of spinal fusion surgeries. The association between pre-operative low back pain, post-operative improvement in functionality (ODI), and prolonged opioid use emphasizes the need for judicious opioid prescribing practices and highlights the role of functional outcomes in treatment goals."

Journal • Observational data • Surgery • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Managing Severe Cancer Pain with Oxycodone/Naloxone Treatment: A Literature Review Update. (PubMed, J Pers Med) - "Through a comprehensive search of databases, studies focusing on the efficacy, safety, and patient experience of oxycodone/naloxone's prolonged release in severe cancer pain management were identified...Overall, the evidence suggests that oxycodone/naloxone combination therapy offers a valuable option for effectively managing severe cancer pain while minimizing opioid-induced constipation, thereby improving patients' quality of life. However, further research is needed to optimize dosing regimens, evaluate long-term safety, and assess patient outcomes in diverse cancer populations."

Journal • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Oncology • Pain

Breast milk oxycodone concentrations in mothers given oxycodone for post-Caesarean delivery pain management. (PubMed, Br J Clin Pharmacol) - "The oxycodone dose received from colostrum and breast milk during the first three postoperative days after Caesarean delivery is assumed safe for healthy, term neonates, but in extreme cases it is possible for the neonate to receive a dose through breast milk that may elicit opioid effects."

Journal • Pain

Pain Relief After Corneal Collagen Cross-Linking (clinicaltrials.gov) - P1 | N=51 | Not yet recruiting | Sponsor: Assaf-Harofeh Medical Center

New P1 trial • Pain

Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (clinicaltrials.gov) - P2/3 | N=150 | Enrolling by invitation | Sponsor: An-Najah National University | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Anesthesia • Pain

Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (clinicaltrials.gov) - P2/3 | N=150 | Enrolling by invitation | Sponsor: An-Najah National University | Trial completion date: Jan 2023 ➔ May 2023 | Trial primary completion date: Jan 2023 ➔ Apr 2023

Trial completion date • Trial primary completion date • Anesthesia • Pain

Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (clinicaltrials.gov) - P2/3 | N=150 | Enrolling by invitation | Sponsor: An-Najah National University | Trial completion date: Jul 2023 ➔ Jan 2023 | Trial primary completion date: Jun 2023 ➔ Jan 2023

Trial completion date • Trial primary completion date • Anesthesia • Pain

ENhANCE trial protocol: A multi-centre, randomised, phase IV trial comparing the efficacy of oxycodone/naloxone prolonged release (OXN PR) versus oxycodone prolonged release (Oxy PR) tablets in patients with advanced cancer. (PubMed, Contemp Clin Trials Commun) - "17/09/2019. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377673&isReview=trueProtocol version 2.1_28 August 2020."

Journal • P4 data • Addiction (Opioid and Alcohol) • Chronic Kidney Disease • Constipation • Gastroenterology • Gastrointestinal Disorder • Hepatology • Liver Failure • Nephrology • Neuralgia • Oncology • Pain • Palliative care • Renal Disease

Oxycodone-Naloxone Combination Hinders Opioid Consumption in Osteoarthritic Chronic Low Back Pain: A Retrospective Study with Two Years of Follow-Up. (PubMed, Int J Environ Res Public Health) - "In 2019, 53 patients suffering from CLBP were treated with either Oxycodone and Naloxone Prolonged Release (27 patients, OXN patients) or Oxycodone Controlled Release (26 patients, OXY patients)...From our results, we can affirm that a long-term opioid treatment with oxycodone-naloxone combination, when compared with oxycodone only, may significantly hinder the development of opioid tolerance. We were also able to confirm, in our cohort, the well known positive effect of naloxone in terms of opioid-induced bowel dysfunction incidence reduction."

Journal • Retrospective data • Back Pain • CNS Disorders • Constipation • Depression • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Lumbar Back Pain • Musculoskeletal Pain • Osteoarthritis • Pain • Psychiatry • Rheumatology

Targin®: An effective opiate analgesia with minimal gastrointestinal side effects-An observational study. (PubMed, J Opioid Manag) - "Only two patients were on opioids at 1-month discharge. This was due to them having Orthopaedic surgery not related to this study."

Adverse events • Journal • Observational data • Gastrointestinal Disorder • Orthopedics • Pain

Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (clinicaltrials.gov) - P2/3 | N=150 | Enrolling by invitation | Sponsor: An-Najah National University

New P2/3 trial • Anesthesia • Pain

NanaBis™ an Oro-buccal Administered delta9-Tetrahydrocannabinol (d9-THC) & Cannabidiol (CBD) Medicine for the Management of Bone Pain From Metastatic Cancers (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Medlab Clinical | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Aug 2023 ➔ Feb 2024

Monotherapy • Trial completion date • Trial primary completion date • Musculoskeletal Pain • Oncology • Pain • Solid Tumor

Targin® for Chronic Pain Management in Patients With Spinal Cord Injury (clinicaltrials.gov) - P4; N=1; Completed; Sponsor: University of British Columbia; Recruiting ➔ Completed; N=20 ➔ 1; Trial completion date: Dec 2022 ➔ Nov 2021

Clinical • Enrollment change • Trial completion • Trial completion date • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Orthopedics • Pain

[VIRTUAL] PROLONGED RELEASE (PR) OXYCODONE/NALOXONE (OXN) FOR CANCER PAIN (CP) & ITS IMPACT ON BOWEL FUN CTION, SA FETY & QUA LITY OF LIFE (QOL): SYSTEMATIC REVIEW (MASCC-ISOO 2021) - "PubMed and EMBASE search for studies evaluating analgesia, bowel function, adverse events (AE) and QoL after OXN PR or oral oxycodone (OXY)/morphine/tapentadol PR, or transdermal fentanyl, in adults with moderate-severe CP. OXN is a valuable option in patients with OIC or nausea from cancer itself or anticancer treatment. This meta-analysis confirms existing evidence on OXN’s c with moderate-severe CP."

Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Targin® for Chronic Pain Management in Patients With Spinal Cord Injury (clinicaltrials.gov) - P4; N=20; Recruiting; Sponsor: University of British Columbia; Trial completion date: Mar 2022 ➔ Dec 2022; Trial primary completion date: Sep 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Complement-mediated Rare Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Orthopedics • Pain

Oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe, chronic cancer pain: Challenges in the context of hepatic impairment. (PubMed, Asia Pac J Clin Oncol) - "Hepatic function test results correlate poorly with presence and extent of liver disease, and are not indicative of porto-systemic shunting. Presence of hepatic impairment should thus be considered when medication-related outcomes with oxycodone-naloxone combination are not as expected, even if liver function test results are normal."

Clinical • Journal • Review • Constipation • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hepatology • Hypertension • Immunology • Oncology • Pain • Portal Hypertension

Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment (clinicaltrials.gov) - P4; N=123; Completed; Sponsor: Mundipharma Korea Ltd; Active, not recruiting ➔ Completed

Clinical • Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

MODERN APPROACHES IN MANAGEMENT OF CHILDREN WITH CHRONIC HEPATITIS B IN REMISSION OF ACUTE LYMPHOBLASTIC LEUKEMIA. (PubMed, Georgian Med News) - "The activity of ALT in the main group was in 1.6 times less (p<0,05) than in comparison group at the end of the course of treatment. «Betargin» has an antifibrotic effect which is confirmed by a decrease in the level of plasma osteopontin up to 104,92 ng/ml against 178,15 ng/ml in the comparison group (p<0,05)."

Clinical • Journal • Acute Lymphocytic Leukemia • Cholestasis • Fibrosis • Hematological Malignancies • Hepatitis B • Hepatology • Immunology • Infectious Disease • Leukemia • Metabolic Disorders • Musculoskeletal Pain • Oncology • Pain • SPP1

Chronic Pain Treatment Strategies in Parkinson's Disease. (PubMed, Neurol Int) - "One of the most used combination drugs for PD is Levodopa-Carbidopa, a dopamine precursor that is converted to dopamine by the action of a naturally occurring enzyme called DOPA decarboxylase. Pramipexole, a D2 dopamine agonist, and apomorphine, a dopamine agonist, and Rotigotine, a dopamine receptor agonist, have showed efficacy on PD-associated pain...Opioids and opioid-like medications such as oxycodone, morphine, tramadol, and codeine are also commonly employed in treatment of chronic pain in PD. Other opioid related medications such as Tapentadol, a central-acting oral analgesic with combined opioid and noradrenergic properties, and Targinact, a combination of the opioid agonist oxycodone and the opioid antagonist naloxone have shown improvement in pain. Anticonvulsants such as gabapentin, pregabalin, lamotrigine, carbamazepine and tricyclic antidepressants (TCAs) can be trialed when attempting to manage chronic pain in PD...A treatment plan can be devised that may..."

Journal • Review • CNS Disorders • Mood Disorders • Movement Disorders • Musculoskeletal Diseases • Neuralgia • Pain • Parkinson's Disease • Peripheral Neuropathic Pain • Psychiatry

[VIRTUAL] Prolonged release (PR) oxycodone/naloxone (OXN) for cancer pain (CP) & its impact on bowel function, safety & quality of life (QoL): Systematic review (ESMO Asia 2020) - "Methods Systematic review of literature from PubMed and EMBASE that evaluated analgesia, bowel function, adverse events (AE) and QoL after OXN PR or oral oxycodone (OXY)/morphine/tapentadol PR, or transdermal fentanyl, in adults with moderate-severe CP...Legal entity responsible for the study: Mundipharma Singapore Holding Pte Ltd. Funding: Mundipharma Singapore Holding Pte Ltd."

Clinical • HEOR • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

[VIRTUAL] Prolonged release (PR) oxycodone/naloxone (OXN) for cancer pain (CP) & its impact on bowel function, safety & quality of life (QoL): Systematic review (ESMO Asia 2020) - "Systematic review of literature from PubMed and EMBASE that evaluated analgesia, bowel function, adverse events (AE) and QoL after OXN PR or oral oxycodone (OXY)/morphine/tapentadol PR, or transdermal fentanyl, in adults with moderate-severe CP...Although limited, this meta-analysis confirms existing evidence on OXN’s efficacy and tolerability in patients with moderate-severe CP and highlights that few data on OXN in CP is available. Mundipharma Singapore Holding Pte Ltd."

Clinical • HEOR • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

[VIRTUAL] Prolonged release (PR) oxycodone/naloxone (OXN) for cancer pain (CP) & its impact on bowel function, safety & quality of life (QoL): Systematic review (ESMO Asia 2020) - "Systematic review of literature from PubMed and EMBASE that evaluated analgesia, bowel function, adverse events (AE) and QoL after OXN PR or oral oxycodone (OXY)/morphine/tapentadol PR, or transdermal fentanyl, in adults with moderate-severe CP...Although limited, this meta-analysis confirms existing evidence on OXN’s efficacy and tolerability in patients with moderate-severe CP and highlights that few data on OXN in CP is available. Mundipharma Singapore Holding Pte Ltd."

Clinical • HEOR • Review • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain

Perioperative steroid administration improves knee function and reduces opioid consumption in bilateral total knee arthroplasty. (PubMed, J Orthop) - "Eighteen patients received 2 doses of 8 mg IV dexamethasone in the perioperative setting. Both Targin® (p = 0.03) (Prolonged-Release Oxycodone) and Fentanyl (p = 0.01) requirements were significantly reduced in the 'steroid' group. We recommend the use of perioperative steroids in bilateral TKA to allow accelerated rehabilitation, improved immediate knee function and an overall reduction in the consumption of potentially problematic opioid-based analgesics."

Journal • Orthopedics • Pain