Rapinyl (fentanyl) / Kyowa Kirin, Orexo, Zydus Lifesci - LARVOL DELTA

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Albert Einstein College of Medicine

New P1 trial • Anesthesia

Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study. (PubMed, Support Care Cancer) - "There was no significant difference in the prevalence of AEs among oxycodone, fentanyl, hydromorphone, and tramadol, which are commonly used for analgesic treatment in Japan."

Adverse events • Journal • Observational data • Addiction (Opioid and Alcohol) • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Nephrology • Oncology • Pain • Palliative care • Renal Disease

NCI-2018-01124: Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (clinicaltrials.gov) - P3 | N=96 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2024 ➔ Jul 2026 | Trial primary completion date: Aug 2023 ➔ Jul 2026

Surgery • Trial completion date • Trial primary completion date • Hepatology • Pain

Medical opioid disposal in Fukuoka and Kumamoto cities. (PubMed, Yakugaku Zasshi) - "In Fukuoka city, the most disposed opioid was 20 mg Oxycontin, worth approximately 940,000 ¥...The most disposed opioid was 5 mg Oxinorm at a cost of 600,000 ¥ at the medical institutions over the 2-year study period...These results indicate that the amount of disposed opioids is huge. Small package simulation studies suggest that smaller package units of MS-Contin, Anpec suppository, and Abstral sublingual tablet may be able to reduce the amount of disposed opioids."

Journal

NCI-2018-01124: Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (clinicaltrials.gov) - P3 | N=96 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2022 ➔ Aug 2023

Surgery • Trial completion date • Trial primary completion date • Hepatology • Pain

The prevalence of off-label prescribing of transmucosal immediate-release fentanyl in France. (PubMed, J Pain Symptom Manage) - "The prevalence of off-label prescribing of TIRF in France is extremely high. A field survey is now needed (i) to better understand why TIRF is used in conditions not indicated in its marketing authorization, and in what clinical situations, and (ii) to determine whether the benefit/risk ratio of such use is favorable."

Journal • Oncology

OASIS: Observational Study of Efficacy, Safety and Tolerability of Fentanyl in Korean Cancer Patients (clinicaltrials.gov) - P=N/A | N=143 | Completed | Sponsor: A.Menarini Asia-Pacific Holdings Pte Ltd | Recruiting ➔ Completed | N=309 ➔ 143

Enrollment change • Trial completion • Oncology • Pain

Procedural pain in patients with cancer: a Delphi expert management consensus. (PubMed, BMJ Support Palliat Care) - "These results provide updated expert-based recommendations on the definition, prevention and treatment of moderate to severe procedural pain, which could inform specialists involved in pain management of patients with cancer."

Clinical • Journal • Hematological Disorders • Oncology • Pain • Palliative care

Feasibility of a transmucosal sublingual fentanyl tablet as a procedural pain treatment in colonoscopy patients: a prospective placebo-controlled randomized study. (PubMed, Sci Rep) - "The sedation and oxygen saturation levels and the respiratory rate did not differ between the groups. The majority of the colonoscopies were completed.Our results indicate that a 100 µg dose of sublingual fentanyl is not beneficial compared to the placebo in the treatment of procedural pain during a colonoscopy."

Clinical • Journal • Anesthesia • Pain

"Class 2 @MHRAmedicines Recall: Abstral 200microgram sublingual tablets (Kyowa Kirin Ltd) https://t.co/y5NyZym34P" (@PSNCNews)

A Case Report of Impaired Consciousness in a Patient after Receiving the Fourth Dose of Fentanyl Sublingual Tablet (PubMed, Gan To Kagaku Ryoho) - "In this case, a 73-year-old man with rectal cancer and third lumbar vertebral metastasis was treated with 100 μg FST and 12.5 μg/h fentanyl patch every day for the management of cancer-related breakthrough pain. However, his respiration was stable. This case shows that due care should be taken while administering FSTs to patients, specifically geriatric patients with bone metastasis and hypoalbuminemia."

Clinical • Journal • CNS Disorders • Colorectal Cancer • Gastrointestinal Cancer • Geriatric Disorders • Oncology • Pain • Rectal Cancer • Solid Tumor

Effect of opioid exposure on efficacy and tolerability of sublingual fentanyl and subcutaneous morphine for severe cancer pain episodes. Secondary analysis from a double-blind double-dummy, randomized trial. (PubMed, J Pain Symptom Manage) - "In this study, we could not demonstrate an effect of previous opioid exposure, from 20 to 120mg OMEDD, on the absolute and relative efficacy and tolerability of 100 μg FST and 5 mg SCM for severe cancer pain episodes."

Clinical • Journal • Oncology • Pain

The reasons and timing of the oral transmucosal fentanyl administration in Japan (ESMO Asia 2017) - "...Median dose of fentanyl patch was 25mcg/hr (range 12.5-250mcg/hr). 90 patients (81%) had difficulties in the administration of oral medicine, which was the main reason of Abstral administration...ROO was administered for the patients who cannot take the oral medicine while it is supposed to be administered to those who want to relieve BTcP fast. In addition, it was administered after aggressive treatment in many patients. The study results represented the short prognosis of these patients."

Retrospective data • Oncology

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

Orexo settles Abstral US patent litigation with Actavis (Businesswire) - "Orexo AB (publ) today announced that it has entered into a settlement and license agreement with Actavis Laboratories...to settle the patent litigation regarding Abstral® in the U.S....The agreement allows Actavis to enter the market in June 2018, or earlier under certain conditions.

Corporate lawsuit • Pain

Orexo receives paragraph IV notice letter concerning Abstral in the US (Reuters) - "Orexo AB...today announced that it has, together with its partner Galena Biopharma, Inc. ('Galena'), received a 'Paragraph IV' patent certification notice from Actavis Laboratories FL, Inc. ('Actavis'). The Notice Letter advice Orexo of Actavis’s filing of an Abbreviated New Drug Application ('ANDA') with the U.S. Food and Drug Administration seeking approval of generic versions of Abstral® (fentanyl) sublingual tablets prior to the expiration of Orexo’s patents listed in the Orange Book."

ANDA • Pain

Fentanyl Sublingual Tablets Versus Subcutaneous Morphine for the Management of Severe Cancer Pain Episodes in Patients Receiving Opioid Treatment: A Double-Blind, Randomized, Noninferiority Trial. (PubMed) - J Clin Oncol - "Both treatments were safe, and patients preferred the sublingual route of administration. FST provides analgesia with modest to moderate increased risk of lower efficacy compared with SCM."

Journal • Biosimilar • Demo Pain • Oncology • Pain

Sublingual Versus Endovenous Fentanyl for Pain Treatment in Trauma Patients in the Emergency Room (clinicaltrials.gov) - P4; N=108; Active, not recruiting; Sponsor: Azienda Sanitaria dell'Alto Adige; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2018 ➔ Aug 2018; Trial primary completion date: Nov 2017 ➔ May 2017

Enrollment closed • Trial completion date • Trial primary completion date • Biosimilar • Mood Disorders • Pain

Breakthrough Pain Management with Sublingual Fentanyl Tablets in Patients with Cancer: Age Subgroup Analysis of a Multicenter Prospective Study. (PubMed, Drugs R D) - "Age subgroup analyses suggest that SFTs are an effective and safe treatment for the management of BTP in cancer patients of all ages. SFTs may offer a well-tolerated and efficient option to control cancer BTP in the elderly."

Journal • Biosimilar • CNS Disorders • Depression • Oncology • Pain

Galena Biopharma reports fourth quarter and year end 2014 financial results (GlobeNewswire) - "Abstral® (fentanyl) Sublingual Tablets 2014 net revenue hits guidance range with $9.3 million; 2015 net revenue guidance reiterated at $15-$18 million."

Sales • Pain

Drug approval reports (FDA) - Abstral label revised on 04th Nov, 2014.

FDA event • Pain

Orexo announces submission of a New Drug Application for KW 2246 (Abstral) in Japan (Orexo) - “Orexo today communicated that its partner Kyowa Hakko Kirin Co., Ltd has submitted a New Drug Application (“NDA”) in Japan for KW-2246 (Abstral), a fentanyl sublingual tablet developed for the treatment of breakthrough cancer pain”

Japanese regulatory • Pain

Therapeutic experience with tramadol for opioid dependence in a patient with chronic low back pain: a case report. (PubMed, JA Clin Rep) - "Our case highlighted that sustained-release tramadol could be effectively applied as a detoxification agent for iatrogenic opioid dependence in patients with chronic non-cancer pain."

Clinical • Journal

Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets. (PubMed, Drugs R D) - "The results of this study showed that SFTs provided safe and clinically meaningful pain relief in both elderly subgroups. Clinical implications of these findings await validation in large, confirmatory studies to identify age subgroup divergences among elderly cancer patients treated with SFTs."

Clinical • Journal

The efficacy of oral piroxicam fast-dissolving tablets versus sublingual fentanyl in incident breakthrough pain due to bone metastases: a double-blinded randomized study. (PubMed, Support Care Cancer) - "Our study demonstrated that oral piroxicam fast-dissolving tablet is an analgesic alternative to sublingual fentanyl in patients with bone metastasis to control incidental BTP attacks with more favorable cost-benefit values."

Clinical • Journal