fentanyl buccal / Generic mfg. - LARVOL DELTA

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

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (AATD) (clinicaltrials.gov) - P1; N=109; Active, not recruiting; Sponsor: University of Florida; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Fibrosis • Immunology

FDA to approve shared system REMS for TIRF products (FDA) - FDA approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products; This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system; TIRF medicines includes the brand-name drugs Abstral, Actiq, Fentora, Lazanda, and Onsolis

REMS approval • Pain

"Actiq, Fentora (fentanyl transmucosal) dosing, indications, interactions, adverse effects, and more https://t.co/wRGoJI6LhB via @medscape"

Adverse events • Biosimilar

Dismissal of insurers' suit against Cephalon upheld (The Legal Intelligencer) - "The U.S. Court of Appeals for the Third Circuit has affirmed the dismissal of a suit against Cephalon filed by several workers' compensation insurance companies that alleged the drugmaker engaged in off-label marketing of two of its painkillers....The plaintiffs claimed the defendants marketed the drugs Actiq and Fentora—opioid painkillers prescribed to cancer patients—for off-label use in non-cancer patients..."

Corporate lawsuit • Pain

Teva: Annual Report 2015 (Teva) - Anticipated expiry of patents between 2019-2028

Anticipated patent expiry • Pain