Palexia RP (tapentadol extended release) / Assertio, J&J, Grunenthal, Collegium Pharma - LARVOL DELTA

Formulary access to key cancer supportive care medications in U.S. Medicare: Coverage, utilization management, and standardized monthly cost trends (MASCC-ISOO 2026) - "Methods Using Medicare-Part-D formularies from 2019Q1–2025Q1, we performed a descriptive trend study evaluating 23 common supportive care drugs/dose forms spanning antiemetics, opioid and opioid-adjacent analgesics, and common adjuvant symptom agents (e.g., duloxetine, pregabalin), based on NCCN guidelines. In antiemetics, ondansetron 4 mg (tablet/ODT) had 100% coverage but high prior authorization (73.32%), and granisetron 1 mg had PA 89.62% despite low monthly cost (~$16).Opioid access stratified into three patterns:(1) short-acting generics were predominantly quantity-limit (QL) restricted with minimal PA (oxycodone 5 mg and hydromorphone 2 mg: ~95% QL; 0.90% PA; ~$28–$29/month); (2) long-acting regimens were more often PA-gated (fentanyl transdermal PA 49.25%, ~$108/month; methadone 5 mg PA 44.06%, ~$19/month); and(3) novel/brand opioids concentrated high costs and formulary exclusion (tapentadol IR 0.70% coverage, ~$1,494/month; tapentadol ER 1.02%, ~$761/month;..."

Medicare • Reimbursement • US reimbursement • Oncology

Short-term risk of falls among initiators of controlled-release tapentadol versus oxycodone in New South Wales between 2014 and 2020: A population-based retrospective cohort study. (PubMed, PLoS Med) - "Tapentadol (SR) was associated with a lower risk of falls than oxycodone (CR) up to four weeks after initiation, although absolute differences were small. The reduction in risk may be an important consideration in older patients where the consequences of falls are most severe."

Clinical • Journal • Retrospective data • Addiction (Opioid and Alcohol)

Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods Using Real World Data. (PubMed, Learn Health Syst) - "We investigated prescription drug claims for tapentadol extended release (ER) from the Colorado All-Payers Claims Database (2012-2019)...Our modified SPC method, which monitors model misspecification rather than raw prescribing data, detects more periods of changing behavior that better temporally align with risk minimization actions. This tool may be useful for regulatory agencies to independently monitor for emerging risks and prescribing trends to complement REMS assessments."

Journal • Real-world evidence • Addiction (Opioid and Alcohol)

(PREVENT)A Randomized, Double-blind, Placebo-controlled Trial on the Prevention of Chronic Postoperative Pain after Inguinal Hernia and Knee Surgery by Postoperative Treatment with Tapentadol (clinicaltrialsregister.eu) - P4 | N=540 | Recruiting | Sponsor: Leids Universitair Medisch Centrum (LUMC) | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Pain

Zoster sine herpete: An atypical presentation of herpes zoster without rash (ASRA-FALL 2025) - "Of note, they were recently diagnosed with pneumonitis concomitant with severe persistent asthma by a pulmonologist and were on week four of a prednisone taper and trimethoprim-sulfamethoxazole regimen...They were also prescribed lidocaine 5% ointment and advised to continue their chronic pain regimen consisting of tapentadol extended-release 50 mg two times daily to provide neuropathic and nociceptive pain control in addition to acetaminophen, celecoxib, 1% diclofenac gel, and cyclobenzaprine...Discussion ZSH is an important diagnosis to consider for immunocompromised patients presenting with acute, localized, dermatomal pain without skin changes or a clear, identifiable source. Similar to HZ, ZSH treatment includes antivirals like valacyclovir or acyclovir alongside analgesics.2,4,5 Prevention also plays an important role with the herpes zoster vaccine given as a two-dose series.1,4 While rare, prompt diagnosis and timely treatment of ZSH are crucial to avoid..."

Asthma • Fibromyalgia • Herpes Zoster • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Neuralgia • Pneumonia • Respiratory Diseases • Rheumatology • Varicella Zoster

Comprehensive insights into diabetic peripheral neuropathy: pathophysiology and therapeutic approaches. (PubMed, J Diabetes Metab Disord) - "The United States Food and Drug Administration has approved pharmacological treatments for painful diabetic peripheral neuropathy: pregabalin, duloxetine, gabapentin, extended-release tapentadol, tramadol, and the capsaicin 8% patch. Non-Food and Drug Administration-approved therapies, such as amitriptyline and the 5% lidocaine patch, are also widely used...A multifaceted approach incorporating pharmacological and non-pharmacological therapies is essential for optimizing patient outcomes in diabetic peripheral neuropathy. Targeting underlying pathophysiological mechanisms while providing symptomatic relief can enhance treatment efficacy and improve the quality of life for individuals with diabetic peripheral neuropathy."

Journal • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic 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

Decline and Pronounced Regional Variation in Tapentadol Use in the US (APA 2025) - "While much research has focused on opioids like fentanyl and hydrocodone, less is known about tapentadol, an atypical opioid. Tapentadol extended-release (ER), approved in 2013 for diabetic neuropathy-related chronic pain, is not recommended by the American Diabetes Association due to addiction risk and modest pain relief... Tapentadol accounted for 1.3% of Schedule II opioids by morphine milligram equivalents in 2020. Distribution was higher in the South Atlantic (29.0 mg/person) and East South Central (28.8 mg/person) regions compared to the Pacific (12.9 mg/person) and New England (12.8 mg/person). Nationally, tapentadol use declined by 53.8% between 2012 and 2020, with New Hampshire being the only state showing an increase (+13.1%)."

Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Mood Disorders • Neuralgia • Pain • Psychiatry

Study of human bioequivalence of Tapentadol Hydrochloride Prolonged-Release Tablets (ChiCTR) - P=N/A | N=64 | Not yet recruiting | Sponsor: Second Affiliated Hospital of Guangzhou Medical University; Yichang Humanwell Pharmaceutical Co.,Ltd.

New trial • Pain

Pharmacodynamic characteristics and influencing factors of tapentadol for chronic pain relief under dose titration. (PubMed, Front Pain Res (Lausanne)) - "Additionally, subgroup analysis suggested that higher titration doses, higher baseline NRS levels, the use of extended-release tapentadol, and a smaller proportion of male participants were trends associated with better analgesic effects, although the differences were not statistically significant. This model can guide the formulation of dosing titration protocols for tapentadol in clinical research. https://inplasy.com/inplasy-2024-5-0014/."

Journal • PK/PD data • Review • Back Pain • Musculoskeletal Pain • Pain

Tapentadol: A Comprehensive Review of Its Role in Pain Management. (PubMed, Cureus) - "Approved by the FDA in 2008 for immediate release and in 2011 for extended release, tapentadol effectively addresses both nociceptive and neuropathic pain, offering a more favorable efficacy-safety profile compared to traditional opioids such as tramadol. Additionally, tapentadol is gaining recognition as a preferred option for managing significant pain in cancer patients due to its effectiveness and reduced side effects. This review evaluates tapentadol's clinical and pharmacological attributes, systematically analyzing literature on its efficacy, safety, pharmacokinetics, and comparative effectiveness, suggesting that tapentadol is a viable option for effective pain management with potential for broader clinical applications."

Journal • Review • Neuralgia • Oncology • Pain

Pain control and functional recovery as therapeutic goals in patients with chronic musculoskeletal pain: two experiences with tapentadol hydrochloride. (PubMed, Eur Rev Med Pharmacol Sci) - "In the study population, tapentadol prolonged release was effective and well tolerated in treating cLBP and post-traumatic foot/ankle OA chronic pain when used in a multimodal manner. The reduction in pain was accompanied by clinically relevant improvements in patients' functionality and QoL."

Journal • Observational data • Retrospective data • Back Pain • Immunology • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Collegium Announces Authorized Generic Agreement with Hikma Pharmaceuticals USA Inc. for Nucynta and Nucynta ER (GlobeNewswire) - "Collegium Pharmaceutical, Inc...announced it has entered into an authorized generic agreement with Hikma Pharmaceuticals USA Inc...pursuant to which Hikma will have the exclusive right to sell the authorized generic versions of Nucynta and Nucynta ER...in the United States....Under the terms of the agreement: Collegium will manufacture and supply Hikma with all authorized generic product for sale on an exclusive basis during the term of the agreement. Hikma will sell the authorized generic forms of the Nucynta Franchise in the United States, commencing 30 days prior to the anticipated loss of exclusivity for each product, or earlier under certain circumstances. Collegium will receive a meaningful share of net profits of the authorized generic products, that declines based on the number of generic entrants, if any." "

Licensing / partnership • Back Pain • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Collegium Reports Record Fourth Quarter and Full-Year 2023 Financial Results (GlobeNewswire) - "Grew Belbuca total prescriptions 3.2% in the quarter ended December 31, 2023, compared to the prior year quarter....Submitted a pediatric extension to the U.S. Food and Drug Administration (FDA) in December 2023 for the Nucynta Franchise to potentially extend exclusivity of the Nucynta Franchise an additional six months to December 27, 2025, for Nucynta ER and January 3, 2027, for Nucynta. The Company expects a decision in the second half of 2024."

Commercial • sNDA • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Update on Treating Painful Diabetic Peripheral Neuropathy: A Review of Current US Guidelines with a Focus on the Most Recently Approved Management Options. (PubMed, J Pain Res) - "These include three oral medications (duloxetine, pregabalin, and tapentadol extended release) and one topical agent (capsaicin 8% topical system). This article provides an overview of the most recent US guidelines for managing painful DPN, with a focus on the two most recently approved treatment options (SCS and capsaicin 8% topical system), as well as evidence for using FDA-approved and guideline-supported drugs and devices. Also discussed are unmet needs for this patient population, and evidence for potential future treatments for painful DPN, including drugs with novel mechanisms of action, electrical stimulation devices, and nutraceuticals."

Journal • Review • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Tapentadol helps in trigeminal neuralgia: a case report. (PubMed, Ann Palliat Med) - "Despite pain chronification, tapentadol was efficient and well tolerated in TN. Further research is needed to reveal tapentadol's efficacy in neuralgias."

Biomarker • Clinical • Journal • Retrospective data • Review • Neuralgia • Pain

Quality use of publicly subsidised tapentadol in Australia: a population-based analysis. (PubMed, Intern Med J) - "Patterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales."

Journal • Addiction (Opioid and Alcohol) • Pain

The role of tapentadol in cancer pain pharmacotherapy in patients with metastatic malignant disease. (PubMed, Eur Rev Med Pharmacol Sci) - "Tapentadol prolonged-release formulation is an effective pharmacotherapy solution, along with palliative radiotherapy, for pain relief in patients with skeletal metastatic breast cancer. Palliative radiotherapy in these patients does not provide adequate neuropathic pain component relief."

Journal • Metastases • Breast Cancer • Neuralgia • Oncology • Pain • Solid Tumor

Abuse of tapentadol compared to other atypical opioids among individuals entering treatment for opioid use disorders. (PubMed, J Opioid Manag) - "Tapentadol use to get high is less frequent than other atypical opioids. Findings suggest tapentadol is rarely the primary drug abused by an individual."

Journal • Addiction (Opioid and Alcohol) • Pain • Substance Abuse

Comparison of the effects of OPRM1 A118G polymorphism using different opioids: A prospective study. (PubMed, J Pain Symptom Manage) - "Tapentadol and methadone may be more suitable than hydromorphone, oxycodone, and fentanyl for G-allele carriers due to their dual mechanism of action and low susceptibility to OPRM1 A118G polymorphism."

Journal • Oncology • Pain • OPRM1

Differences in the Analgesic Effect of Opioids on Pain in Cancer Patients With Spinal Metastases. (PubMed, Palliat Med Rep) - "A total of 274 patients were enrolled, who started a tapentadol extended-release tablet, methadone tablet, hydromorphone extended-release tablet, oxycodone extended-release tablet, or transdermal fentanyl patch for cancer pain due to spinal metastasis in Japan from January 1, 2013 to October 31, 2021. In patients without numbness, no significant differences were observed in decreases of the NRS scores on day seven among the five groups. Tapentadol and methadone may be more effective than hydromorphone, oxycodone, and fentanyl for cancer pain due to spinal metastasis with numbness."

Journal • Back Pain • Musculoskeletal Pain • Neuralgia • Oncology • Pain • Solid Tumor

Collegium Reports Record 1H’23 Net Revenue of $280.3 Million, Up 35% Year-over-Year (GlobeNewswire) - "Generated Belbuca® total prescription growth of 3.5% compared to the first quarter of 2023. Increased Xtampza® ER revenue 24% year-over-year to $41.2 million. Grew Nucynta Franchise revenue 8% year-over-year to $47.3 million."

Sales • Back Pain • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Physical activity in the first postoperative week in 132 knee arthroplasty patients randomized to 3 different analgesic regimens. (PubMed, Medicine (Baltimore)) - "Patients in the non-opioid placebo group spent more time mobilized the first week after surgery than those in the tapentadol ER and the oxycodone CR groups, while the number of steps was not different between the groups."

Clinical • Journal • Orthopedics • Pain

Appropriate use of tapentadol: focus on the optimal tapering strategy. (PubMed, Curr Med Res Opin) - "Studies for this narrative review were identified via PubMed using a structured search strategy, focusing on management of chronic non-cancer pain with opioids, and the efficacy, tolerability, and pharmacology of tapentadol prolonged release. While tapentadol is associated with a low frequency of opioid withdrawal symptoms after abrupt discontinuation, use of a tapering strategy is prudent. Tapering strategies developed for opioids in general can potentially be safely individualized in tapentadol-treated patients, although research on tapering strategies for tapentadol is required."

Journal • Review • Gastrointestinal Disorder • Oncology • Pain

Cebranopadol, a Novel Potent Analgesic: Review of Clinical Studies Conducted Across Multiple Types of Pain including Chronic Lower Back Bain, Acute Pain, Diabetic Peripheral Neuropathy, and Cancer Pain (PAINWeek 2022) - "Across the 8 trials, patients were randomized to receive 25-1000μg/day of cebranopadol by mouth or a control including , placebo, morphine sulfate sustained release (SR), tapentadol prolonged release (PR), morphine sulfate PR, pregabalin, or oxycodone controlled release (CR), for a duration of 2 days to 15 weeks... Cebranopadol has demonstrated efficacy across a variety of pain types, and when considered along with safety and abuse potential data may serve as a much-needed treatment option for patients with moderate to severe pain. Learning Objectives: Upon completion, participant will be able to describe the clinical studies used to study the efficacy and safety of cebranopadol. Upon completion, participant will be able to identify the pain types that cebranopadol has demonstrated efficacy in Upon completion, participant will be able to describe the safety of cebranopadol in patients"

Clinical • Review • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain • Peripheral Neuropathic Pain