fentanyl buccal / Generic mfg. - LARVOL DELTA

Development and preliminary validation of a clinician-administered Chinese-language tool for breakthrough cancer pain assessment. (PubMed, Asia Pac J Oncol Nurs) - "In an exploratory observational phase, selected BCPA responses were compared in 77 participants before and 7 days after routine-care initiation of fentanyl buccal soluble film. Selected rescue medication-related items detected pre/post changes in an uncontrolled observational sample. Further evaluation of response processes, criterion-related validity, cross-cultural validity, and responsiveness is required before routine clinical implementation."

Journal • Oncology • Pain

Establishing an efficacy hierarchy for breakthrough cancer pain management: a network meta-analysis of rapid-onset fentanyl formulations and morphine. (PubMed, BMC Med) - "This analysis provides evidence for a relative efficacy hierarchy among rapid-onset opioids for BTP. INFS demonstrated the most rapid and sustained analgesia across all evaluated time points, while FBT consistently ranked second. The delayed onset of MSIR warrants consideration when selecting agents for rapid pain relief. Treatment selection should integrate these efficacy data with safety profiles, route feasibility, and patient-specific factors."

Journal • Retrospective data • Oncology • Pain

A NATIONAL PHARMACOEPIDEMIOLOGIC STUDY OF RAPID‑ONSET OPIOIDS FOR ADVANCED CANCER IN AUSTRALIA, 2013–2024: RARELY USED, INTENSIVELY DOSED (MASCC-ISOO 2026) - "Three rapid‑onset opioids (ROOs) were PBS‑listed and included: oral transmucosal fentanyl citrate (OTFC), fentanyl sublingual tablets (FST), and fentanyl buccal tablets (FBT). Descriptive statistics summarised prescribing frequency and oral morphine equivalent daily dose (OMEDD)...Median ROO dose was much higher than other immediate‑release opioids, whereas non-ROO doses have reduced slightly over 13 years. Key drivers of rare ROO use and reasons for relative high dosing warrant further investigation."

Clinical • Metastases • Oncology

Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Universidad Europea de Canarias | N=50 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Musculoskeletal Pain • Oncology • Pain

Three-component synthesis of β-thio tertiary alkylamines from simple alkenes via SH2 homolytic substitution. (PubMed, Sci Adv) - "Mechanistic investigations reveal a key bimolecular homolytic (SH2) substitution process that efficiently traps the nascent C(sp3)-centered radical intermediates in acidic media and facilitates the C─S bond formation with high regioselectivity and even primary enantiocontrol. The introduced S-based functionality can improve the performance of pharmaceuticals such as Fentora."

Journal

Efficacy of fentanyl buccal tablet and morphine for exertional dyspnoea in patients with cancer: a double-blind, placebo-controlled, randomised clinical trial. (PubMed, Thorax) - P3 | "All three groups reported less dyspnoea while walking farther; however, no difference was detected between opioids and placebo. These findings should be considered preliminary given the underpowered sample."

Journal • Asthma • Immunology • Oncology • Palliative care • Pulmonary Disease • Respiratory Diseases

Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2025 ➔ Aug 2027 | Trial primary completion date: Aug 2025 ➔ Aug 2027

Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology • Pulmonary Disease • Solid Tumor

Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Oncology • Pulmonary Disease • Solid Tumor

Effectiveness of fentanyl buccal soluble film in cancer patients with inadequate breakthrough pain control. (PubMed, BMC Palliat Care) - P=N/A | "FBSF can be administrated "on demand" by cancer patients at the onset of BTcP, providing rapid analgesia by achieving meaningful pain relief within 10 min."

Journal • Oncology • Pain

Effectiveness of Percutaneous Neuromodulation vs Pharmacological Treatment in Cancer Patients With Anterior Knee Pain (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: Universidad Europea de Canarias

New trial • Musculoskeletal Pain • Oncology • Pain

Influence of NMB reversal on early neurocognitive function after general anesthesia (ASA 2023) - "This is supported by the EMEA's "Assessment Report for Bridion" on sugammadex, which notes "… a possible flattening of anaesthesia with intraoperative administration of Sugammadex.", and reports: "Most anaesthetic complications and coughing were reported in subjects receiving fentanyl and propofol and not in subjects receiving remifentanil or sevoflurane...Fentanyl redistribution from 'reservoirs' can lead to opioid overstimulation at the end of anesthesia which potentially leads to delayed Neurocognitive recovery and an increased risk of hypoxia.Primarily, the gamma-cyclodextrin, sugammadex binds rocuronium by forming a high-affinity complex via hydrogen bonds (kass: 1.79-107 mol/L) and is eliminated by renal clearance...The possibility of physical-chemical interactions via these Van-der-Waals interactions between cyclodextrins and fentanyl is supported by work in the field of pharmaceutical technology for buccal fentanyl..."

Addiction (Opioid and Alcohol) • Anesthesia • Pain

"Specific Lots of Fentanyl Buccal Tablets by Teva: Recall - Due to a Labeling Error https://t.co/8Axcwzwyf4" (,@FDAMedWatch)

Effect of prophylactic fentanyl buccal tablet (FBT) on exertional dyspnea in patients with cancer: A pilot double-blind, placebo-controlled, randomized trial. (ASCO 2017) - P2; "These data support our hypothesis that proportionally dosed FBT was associated with improvement in exertional dyspnea, and highlights the need for larger confirmatory trials."

Clinical • Biosimilar • Oncology

Predicting tolerability of high-dose fentanyl buccal tablets in cancer patients. (PubMed, PLoS One) - "According to the dose relationship between the final FBT dose and the clinical features, three factors (sex, age, daily use of FBT) were independently associated with the final dose of FBT. Our risk score model could help predict tolerance to high-dose FBT and guide the titration plan for BTcP."

Journal • Addiction (Opioid and Alcohol) • Oncology • Pain

Opioids for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Pain

Comparison table: Some oral/transdermal opioid analgesics. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Pain

An Observation Study to Assess the Efficacy and Safety of Proportional Doses of Painkyl® in Patients With Breakthrough Cancer Pain (clinicaltrials.gov) - P=N/A | N=37 | Completed | Sponsor: Mackay Memorial Hospital | Recruiting ➔ Completed

Trial completion • Oncology • Pain

Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions (clinicaltrials.gov) - P2 | N=5 | Terminated | Sponsor: University Hospitals Cleveland Medical Center | N=32 ➔ 5 | Trial completion date: Dec 2013 ➔ Dec 2021 | Trial primary completion date: Dec 2013 ➔ Dec 2021

Enrollment change • Trial completion date • Trial primary completion date • Anesthesia • Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Immunology • Ischemic stroke

Fentanyl Buccal Tablet or Morphine for Exertional Dyspnea in Cancer Patients (clinicaltrials.gov) - P3; N=150; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Oncology • Pulmonary Disease • Solid Tumor

Improving Pediatric Drug Safety in Prehospital Emergency Care-10 Years on. (PubMed, J Patient Saf) - "The distribution of the PaedER combined by educational measures significantly reduced the rates of life-threatening medication errors in a large EMS. Those results should motivate further initiatives on pediatric drug safety in prehospital emergency care."

Clinical • Journal • Pediatrics

'Nasal fentanyl and buccal midazolam carer administration 'as needed' for breakthrough symptom control in a specialist palliative care unit: a nested qualitative study'. (PubMed, BMJ Support Palliat Care) - "Participation was acceptable to patients and lay carers, and beneficial for symptom relief. The findings will inform planning for a future community-based study."

Journal • Oncology • Palliative care

Clinical outcomes of concomitant rifamycin and opioid therapy: a systematic review. (PubMed, Pharmacotherapy) - "Available literature suggests that a decrease in opioid clinical effects are appreciated with concomitant rifamycin therapy. Further research is needed to focus on specific mitigation strategies beyond opioid agent selection, such as dosing adjustment recommendations."

Clinical • Clinical data • Journal • Review • Pain

The role of fentanyl in the treatment of breakthrough cancer pain: Different biotechnologies, different results and different drug costs. (PubMed, J Oncol Pharm Pract) - "The aim of this paper was to assess the drug costs of the different biotechnologies (intranasal fentanyl spray (INFS), oral transmucosal fentanyl citrate (OTFC) and fentanyl buccal tablet (FBT)) in the treatment of breakthrough cancer pain (BTCP). INFS resulted the less expensive towards OTFC and FBT, with 697 440 €versus (vs.) 809 552 €vs. 779 662 €every 100 patients treated for BTCP, respectively. In conclusion, combining drug costs of different biotechnologies (INFS, OTFC and FBT) with the measure of efficacy represented by the reduction of BTCP avoided (incremental cost-effectiveness ratio, ICER), INFS resulted in better cost-effectiveness."

HEOR • Journal • Oncology • Pain

Fentanyl Sublingual Tablet or Morphine for the Control of Shortness of Breath During or After Physical Activity in Cancer Patients (clinicaltrials.gov) - P3; N=150; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center; Initiation date: Apr 2020 ➔ Apr 2021

Clinical • Trial initiation date • Oncology • Solid Tumor

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (AATD) (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: University of Florida; Trial primary completion date: Apr 2016 ➔ Apr 2017

Trial primary completion date • Biosimilar • Fibrosis • Immunology • Inflammation