Nucynta (tapentadol) / Collegium Pharma, Grunenthal - LARVOL DELTA

Therapeutic challenges in a rare trigeminal autonomic cephalalgia (EHF-EHC 2025) - "A discrete improvement was noted with intravenous eptinezumab 300 mg every 12 weeks, in combination with duloxetine, gabapentin, topiramate and tapentadol. He makes excessive use of fast-acting tramadol and ibuprofen to alleviate acute pain...SUNCT remains a therapeutic challenge due to its rarity, limited evidence base, and frequent refractoriness. This reinforces the need for further research and therapeutic innovation."

Rheumatology

Effect of tapentadol combined with transverse abdominis plane block on postoperative pain in patients undergoing laparoscopic total hysterectomy (ChiCTR) - P=N/A | N=96 | Not yet recruiting | Sponsor: The First People’s Hospital of Jingzhou; The First People’s Hospital of Jingzhou

New trial • Cervical Cancer • Endometriosis • Gynecology • Oncology • Pain • Solid Tumor • Uterine Leiomyoma • Women's Health

Efficacy and safety of pre-emptive tapentadol on pain control in total knee arthroplasty: A randomized, double-blind, placebo-controlled trial. (PubMed, World J Orthop) - "A preemptive single dose of 100 mg oral tapentadol is safe, effective, and significantly reduces postoperative pain and rescue analgesic requirements in TKA patients. This approach may reduce opioid dependence and support enhanced recovery protocols."

Clinical • Journal • Addiction (Opioid and Alcohol) • Musculoskeletal Diseases • Orthopedics • Pain

Effect of Preventive Analgesia with Tapentadol Fumarate on the Incidence of Postoperative Nausea and Vomiting in High-Risk Patients Undergoing Thyroid and Breast Surgery: A Prospective, Double-Blind, Positive-Controlled Trial (ChiCTR) - P4 | N=152 | Not yet recruiting | Sponsor: Guangzhou Institute of Cancer Research,the Afliated Cancer Hospital, Guangzhou Medical University; Guangzhou Institute of Cancer Research,the Afliated

New P4 trial

OPIOID AVAILABILITY FOR PAIN IN PEDIATRIC ONCOLOGY POPULATIONS IN LOW- AND MIDDLE-INCOME COUNTRIES: A PAUCITY OF RESEARCH (SIOP 2025) - "The most frequently reported opioids were morphine and fentanyl, in 11 and 10 articles respectively, followed by tramadol (4), pethidine, methadone, and codeine (2 each), and tapentadol, remifentanil, alfentanil, and oxycodone (one each). Our finding of limited opioid research in pediatric oncology in LMICs highlights a significant research gap and possibly limited access to opioids for pain in LMICs in pediatric oncology. In the context in which opioid distribution is unequal and inequitable generally, this is especially concerning for the vulnerable pediatric oncology population."

Clinical • Pain • Palliative care • Pediatrics

Comparison of the 95% Effective Dose (ED95) and Efficacy between Tegileridine Fumarate and Fentanyl in Hysteroscopic Surgery: A Prospective, Multicenter, Randomized Controlled Trial (ChiCTR) - P=N/A | N=182 | Not yet recruiting | Sponsor: First Affiliated Hospital of Gannan Medical University; First Affiliated Hospital of Gannan Medical University

New trial

Preclinical assay of the effects of lacosamide, pregabalin, and tapentadol on the rat N1 spinal somatosensory evoked potential. (PubMed, Pain) - "Pregabalin (at any dose up to 30 mg/kg) did not modulate the N1 amplitude. These results show that the spinal N1 is differentially modulated in a way that reflects distinct mechanisms of analgesic action consistent with it being a translatable biomarker of target engagement."

Journal • Preclinical • Anesthesia • Pain

A Multicenter, Randomized, Open-Label, Active-Controlled, Parallel-Group Study Evaluating the Pharmacokinetics of Single-Dose Tapentadol Hydrochloride Intravenous Infusion and Tapentadol Hydrochloride Oral Tablets in Patients with Pain. (PubMed, Eur J Drug Metab Pharmacokinet) - "Tapentadol IV exhibits precise pharmacokinetics, promising pharmacodynamic properties, and a favorable safety profile compared with IR and ER routes for patients with moderate noncancer pain, supporting further clinical research and development of tapentadol injection."

Journal • PK/PD data • Oncology • Pain

EXPRESS: Efficacy of combined grapiprant and tapentadol for analgesia in cats undergoing elective ovariohysterectomy. (PubMed, J Feline Med Surg) - "At 3 hours postoperatively, FGS scores differed significantly between CON and GT groups (p = 0.0363). Rescue analgesia requirements also varied among groups (p = 0.0110): GT required rescue at 3 hours, compared with 1 hour in CON (p = 0.0007) and 2 hours in GRA (p = 0.0058).The results of this study showed that the analgesic effect of the grapiprant-tapentadol combination lasted up to 3 hours in the postoperative period, which was longer than the 2 hours of grapiprant and tapentadol alone, without compromising intraoperative physiological stability."

Journal • Anesthesia • Gynecology • Pain

Prevalence and Predictors of Opioid Use Before Spine Surgery: A Multicenter, Cross-Sectional Observational Study. (PubMed, Pharmacol Res Perspect) - "The most frequently used opioids were oxycodone (32%), codeine (20%), and tapentadol (9%)...Given the risks of opioids, efforts to better understand and manage opioid use before spine surgery are warranted. Addressing this issue could lead to more effective pain management strategies and improved patient outcomes."

Journal • Observational data • Orthopedics • Pain

Stereodivergent Synthesis of Allylic All-Carbon Quaternary Centers by Bimetallic Iridium/Magnesium-Catalyzed Allylic Alkylation. (PubMed, J Am Chem Soc) - "The synthetic utility of this methodology is demonstrated through the preparation of key intermediates for a number of natural products. Particularly, stereodivergent synthesis of an analgesic drug derivative Me-tapentadol has been achieved, exhibiting significantly enhanced μ-opioid receptor agonistic activity compared to its parent compound."

Journal • Pain

Long-Term Neuropathic Pain Management Following Thoracolumbar Neurinoma Surgery: A Case Report withMultimodal and Neuromodulation Strategies (NeuPSIG 2025) - "Psychological screening questionnaires revealed positive scores for anxiety and depression at baseline, highlighting the need for an integrated biopsychosocial approach.Strategies included medication adjustments (carbamazepine, duloxetine, trazodone, methadone, and eventually tapentadol), cannabis-based therapy, epidural and transforaminal blocks, pulsedradiofrequency (PRF) of dorsal root ganglia (DRGs), sympathetic blocks via venous access (BSV), and spinal cord stimulation (SCS)...Within one week, the patient experienced a 70% reduction in pain, with a mean pain score of 2/10 and low interference in daily function: 30% for general activity and interpersonal relations, and no interference with work or enjoyment of life.This improvement was achieved while maintaining a stable regimen of duloxetine, trazodone, methadone, and pregabalin... This case demonstrates the value of individualized, stepwise multimodal management for complex neuropathic pain, especially when..."

Case report • Clinical • Surgery • CNS Disorders • Depression • Neuralgia • Pain • Psychiatry

Spinal somatosensory-evoked potential modulation by tapentadol is mediated through inhibition of wide dynamic range neuronal activity (NeuPSIG 2025) - "Here, using single unit analysis, we have shown that the evoked activity of WDR neurons contributes to the generation of the N1 component and are the likely neuronal correlate of the analgesic sensitive component of the N1 SEP. Pharmacological reversal of the tapentadol effect by naloxone confirms this biomarker is sensitive to opioidergic modulation."

CNS Disorders • Neuralgia

Health Care Professionals’ Perspectives of Inadequately Managed Painful Diabetic Peripheral Neuropathy: A Qualitative Analysis (PAINWeek 2025) - "Five products have been approved by the US Food and Drug Administration (FDA) for the management of pain associated with DPN: duloxetine, pregabalin, tapentadol, capsaicin 8% patch, and spinal cord stimulation devices...The most frequently prescribed first-line therapies included gabapentin (n=16), pregabalin (n=7), topical creams (n=7), and duloxetine (n=6)... Twenty HCPs participated in the study, with an equal distribution between generalists (family medicine or internal medicine; n=10) and specialists (neurology, n=5; pain medicine, n=5). The sample was mostly male (n=13, 65%) and White (n=11, 55%). On average, participants had 24.3 years of experience managing painful DPN and reported treating between 2-50 patients with pain associated with DPN per week."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Epilepsy • Neuralgia • Pain • Peripheral Neuropathic Pain • Psychiatry • Sleep Disorder

Route of Administration and Other Clinical Outcomes Among Exposures to Buprenorphine Pain Medications and Schedule II Opioids (PAINWeek 2025) - "Four study groups were studied: buprenorphine buccal film (BBF), buprenorphine transdermal patch (BTP), CII immediate-release (CII-IR) opioids, and CII extended-release (CII-ER) opioids. CII opioid compounds included solid oral dosage forms of hydrocodone, oxycodone, hydromorphone, oxymorphone, and tapentadol... From 1 January 2020 to 31 December 2023, there were 276 exposures to BBF (9 resulted in a major effect or death); 134 exposures to BTP (13 resulted in a major effect or death); 43,322 exposures to CII-IR opioids (5,519 resulted in a major effect or death); and 2,453 exposures to CII-ER opioids (435 resulted in a major effect or death) reported to NPDS. The risk of exposure resulting in major effect or death was greatest for CII-ER opioids (0.18), followed by CII-IR opioids (0.13), BTP (0.10) and lowest for BBF (0.03). Exposure resulting in major effect or death was 3.91 times (95% CI: 2.05,7.43) greater for CII-IR opioids, 5.44 times (95% CI: 2.84,10.40) greater..."

Clinical • Clinical data • Addiction (Opioid and Alcohol) • CNS Disorders • Pain

Clinical Outcomes Translated to Healthcare Costs: Comparison of Buprenorphine Pain Medications with Full-agonist Extended-Release Opioids (PAINWeek 2025) - "Buprenorphine has potentially fewer negative side effects and adverse events than other opioids used for chronic pain treatment (Adler et al., 2024), such as full-agonist opioids fentanyl, hydromorphone, morphine and oxycodone (Dalal et al., 2021)... This was an observational, cross-sectional study design with three groups: buprenorphine buccal film (BBF), buprenorphine transdermal patch (BTP) and full-agonist extended-release opioids (FA-ER; included ER oxycodone, ER hydromorphone, ER oxymorphone, and ER tapentadol)... From 01 January 2020 to 31 December 2023, there were 276 reported exposures to BBF; 134 reported exposures to BTP; and 2,453 reported exposures to FA-CII opioids. Of these, intentional abuse or misuse exposures involving BBF and BTP were similar to one another and lower than rates of FA-ER exposures: BBF intentional abuse/misuse exposures n= 41 (14.9%); BTP exposures n=19 (14.2%); and FA-ER opioid exposures n= 665 (27.1%). Percentages of admissions to a..."

Clinical • Clinical data • HEOR • Addiction (Opioid and Alcohol) • CNS Disorders • Pain • Substance Abuse

The efficacy and safety of XG005, a novel non-opioid chemical entity concurrently inhibiting both nociceptive and neuropathic signals, in managing post-operative pain: a randomized, placebo-controlled phase 2b trial (PAINWeek 2025) - P2/3 | "XG005 is a single molecule conjugating naproxen and pregabalin, which is not active in gastrointestinal tract and thus minimizes naproxen side effects compared with administering naproxen directly...Qualified subjects were randomized (1:1:1) to receive either 1250 mg or 750 mg of XG005 tablets, or placebo...Tramadol consumption in the placebo group was 4.1- or 3.0-fold more than in the 1250 mg or 750 mg groups over 72 hours, and those were 3- or 2.5-fold in acetaminophen consumption...In comparison with other analgesics to treat acute pain using the same bunionectomy model with the same efficacy endpoint (SPI48) or Summed Pain Intensity Difference at 48 hours (SPID48), the pooled mean effect sizes are: 0.59 with various NSAIDs, 0.52 with various opioids combination with either acetaminophen or NSAIDs, 0.88 with tapentadol (an opioid) and 0.36 with a Nav1.8 antagonist... This trial randomized 450 participants (median age, 48 years; 80% female) with comparable..."

Clinical • P2b data • Addiction (Opioid and Alcohol) • CNS Disorders • Neuralgia • Pain • Psychiatry • Sleep Disorder • NAV1

Short-term stability evaluation of synthetic opioids, cathinones and ketamine in dried urine spots. Method validation and application to real cases. (PubMed, Forensic Sci Int) - "This study validates an LC-MS/MS method for the simultaneous quantification of twelve psychoactive drugs in DUS: methadone, EDDP, oxycodone, tapentadol, tramadol, ketamine, norketamine, fentanyl, carfentanyl, furanyl fentanyl, 3,4-MD-α-PHP, and MDPV. Nevertheless, molecule-specific stability profiles necessitate tailored validation strategies. Future studies should expand the analyte range and assess long-term stability under variable environmental conditions."

Journal • Addiction (Opioid and Alcohol) • Anesthesia

Pulmonary Arterial Hypertension Due to Talc Granulomatosis Following Intravenous Use of Oral Medications: A Report of a Rare Case. (PubMed, Cureus) - "A detailed history revealed longstanding intravenous polysubstance abuse over five years, including methamphetamine, tapentadol, and cocaine, likely contributing to his pulmonary pathology...The patient was managed with supplemental oxygen, antiplatelet therapy, and oral sildenafil, resulting in symptomatic improvement, and was strongly advised to cease intravenous drug use. A lung biopsy was planned for histological confirmation. This case report aims to emphasize the importance of recognizing pulmonary talc granulomatosis as a rare but serious complication of intravenous drug use, particularly in patients presenting with unexplained respiratory symptoms, due to its potential to cause irreversible PAH if left untreated."

Journal • Cardiovascular • Cough • Fatigue • Hypertension • Inflammation • Pain • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TAPentadol vs OxycodoNe on the incidence of persistent opioid use after hip or knee arthroplasty (TAP-ON Study) (ANZCTR) - P=N/A | N=60 | Not yet recruiting | Sponsor: The University of Sydney

New trial • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

Tapentadol withdrawal, a newer trend in opioid overuse in Nepal: A case report. (PubMed, J Nepal Health Res Counc) - "Genetic counselling is essential for the recognition and prevention of severe hyperbilirubinemia which, in the absence of timely medical intervention, may lead to neurotoxicity. Keywords: Case report; crigler-Najjar syndrome; genetic counseling; phenobarbitone; unconjugated hyperbilirubinemia."

Journal • Genetic Disorders • Metabolic Disorders • UGT1A1

Combination of Tapentadol Nasal Spray and Radiotherapy for Managing Moderate-to-Severe Pain from Lytic Bone Metastasis. (PubMed, Ann Afr Med) - "Tapentadol nasal spray presents a favourable option for bone metastasis pain management along with radiotherapy, offering improved pain reduction, better sleep outcomes, and enhanced patient comfort. The nasal delivery method proves efficient and patient-friendly, marking a significant advancement in achieving early and sustained pain relief."

Journal • Oncology • Pain • Solid Tumor

Urinary metabolic ratio of pain management and substance abuse treatment drugs: Drug-drug interactions. (PubMed, J Opioid Manag) - "The 18 drugs include dextromethorphan, oxycodone, hydrocodone, tramadol, morphine, buprenorphine, fentanyl, clonazepam, alprazolam, quetiapine, carisoprodol, tapentadol, ketamine, methadone, impramine, and amitriptyline. The 14 interfering drugs include fluoxetine, paroxetine, bupropion, citalopram, sertraline, venlafaxine, duloxetine, risperidone, trazodone, aripiprazole, cyclobenzaprine, amphetamine, and tetrahydrocannabinol...Using the MR reference intervals of the 18 drug pairs established in an earlier study, and the current DDI system, we can alert providers of unusual metabolism caused by DDIs. This will help providers do better prescribing or review more closely all medications and supplements patients are taking, thus avoiding underdosing or potential medication adverse reactions."

Journal • Pain • Substance Abuse • CYP2C19 • CYP3A4

Urinary metabolic ratio of pain management and substance abuse treatment drugs: Reference intervals. (PubMed, J Opioid Manag) - "These drugs were dextromethorphan, morphine, oxycodone, hydrocodone, quetiapine, tapentadol, tramadol, buprenorphine, clonazepam, fentanyl, imipramine, ketamine, carisoprodol, alprazolam, methadone, and amitriptyline. Ratio values outside of this reference range could be considered to be caused by genetic metabolizing variants, drug-drug interactions, age, or deception. Alerting providers of the variance in metabolism from the expected norm might reduce overdosing or underdosing patients."

Journal • Pain • Substance Abuse

Immunalysis Tapentadol Assay Reformulation Resolves Tramadol Interference. (PubMed, J Anal Toxicol) - "These findings demonstrate the importance of assay verification to assess cross-reactivity, particularly for structurally related compounds. The reformulated Immunalysis Tapentadol 343UR kit shows improved specificity, reducing false-positive rates and enhancing the accuracy of tapentadol detection in clinical and forensic toxicology applications."

Journal • Pain