Lazanda (fentanyl) / Assertio, Kyowa Kirin - LARVOL DELTA

Pain Control Alternatives in Pediatric Patients With Distal Radius Fractures (clinicaltrials.gov) - P3 | N=50 | Not yet recruiting | Sponsor: State University of New York at Buffalo

New P3 trial • Musculoskeletal Diseases • Orthopedics • Pain • Pediatrics

Clinical and pharmacokinetics overview of intranasal administration of fentanyl. (PubMed, Heliyon) - "However, there is limited available literature about the serious adverse effects of INF in adults and children. Intranasal Fentanyl Spray (INFS) results in significantly higher plasma concentrations and has a lower T than oral transmucosal formulation, and the bioavailability of fentanyl in intranasal formulations is very high (89 %), particularly in pectin-containing formulations such as PecFent and Lazanda."

Journal • PK/PD data • Review • Oncology • Pain • Renal Calculi

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

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

Breakthrough pain in patients with head & neck cancer. A secondary analysis of IOPS MS study. (PubMed, Oral Oncol) - "BTcP in patients with H&N cancer is characterized by a larger number of episodes/day and the predictability, particularly with ingestion of food. The use of drugs for background analgesia and BTcP were conditioned by the possible interference with swallowing or local mucosal damage."

Clinical • Journal • Head and Neck Cancer • Mucositis • Oncology • Pain • Solid Tumor • Stomatitis

Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer. (PubMed, Patient Prefer Adherence) - "Patient quality of life was maintained throughout the radiotherapy period. This study showed, in a real-life setting, that a clear majority of H&N cancer patients treated with FPNS for BTcP throughout radiotherapy expressed satisfaction with this analgesic treatment."

Clinical • Journal • CNS Disorders • Depression • Head and Neck Cancer • Mood Disorders • Oncology • Pain • Solid Tumor

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

Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) - P4; N=3; Terminated; Sponsor: M.D. Anderson Cancer Center; N=60 -> 3 ; Recruiting -> Terminated

Enrollment change • Trial termination • Biosimilar • Pain

Depomed reports first quarter 2015 financial results (PRNewswire) - " '...With NUCYNTA, we are now expecting 2015 total product sales of $310-$335 million, which is nearly triple our 2014 product sales and over five times 2013 product sales.'...First quarter 2015 net sales (for Gralise) were $17.3 million, up 59% compared to $10.9 million in first quarter 2014....First quarter 2015 net sales (for Cambia) were $5.4 million, up 16% compared to $4.6 million in first quarter 2014....First quarter 2015 net sales of $3.2 million (for Lazanda), up 369% compared to $680,000 in first quarter 2014....First quarter 2015 net sales (for Zipsor) of $5.8 million, up 9% compared to $5.3 million in first quarter 2014."

Sales • Sales projection • Pain

Depomed reports record fourth quarter and full year 2015 financial results (Depomed Press Release) - "NUCYNTA (tapentadol and tapentadol extended release)...Fourth quarter net sales of $68 million, a 55% increase over the $44 million sold by Janssen in fourth quarter 2014....Gralise® (gabapentin): Full-year net sales of $81 million, an increase of 34% compared to $60 million in 2014....Cambia® (diclofenac potassium for oral solution): Full-year net sales of $27.4 million, an increase of 26% compared to $21.7 million in 2014....Lazanda® (fentanyl) Nasal Spray (CII): Full-year net sales of $17.7 million, an increase of 154% compared to $7.0 million in 2014."

Sales • Pain

Depomed reports second quarter 2016 financial results (Depomed Press Release) - "NUCYNTA and NUCYNTA ER: Second quarter 2016 net sales of $72 million. Net sales of $331 million since acquisition on April 2, 2015. Gralise® second quarter 2016 net sales were a record $23.8 million, an increase of 14% compared to $20.9 million in the same period last year. Cambia® second quarter 2016 net sales were $7.6 million...Lazanda® second quarter 2016 net sales were a record $6.4 million..."

Sales • Demo Pain • Pain

FCNS: An Assessment of the Ability of Fentanyl Citrate Nasal Spray to Manage Breakthrough Pain in Cancer Patients. (clinicaltrials.gov) - P4; N=0; Withdrawn; Sponsor: James Graham Brown Cancer Center; N=40 ➔ 0; Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Biosimilar • Oncology • Pain

Depomed announces acquisition of Lazanda (fentanyl) nasal spray from Archimedes Pharma Limited (PRNewswire) - "Depomed...today announced that it has acquired all United States and Canadian rights to Lazanda® (fentanyl) nasal spray from Archimedes Pharma Limited. Lazanda is indicated for the management of breakthrough pain in cancer patients (BTPc) 18 years of age and older who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain."

Licensing / partnership • Pain

Depomed releases Lazanda 300 mcg dose for treatment of breakthrough cancer pain (PRNewswire) - "Depomed today announced that Lazanda® (fentanyl) nasal spray, CII, is now available at a 300 mcg dose strength to treat breakthrough cancer pain (BTPc), offering physicians another titration option for dosing flexibility...Lazanda can now be titrated to 200, 300, 400, 600 or 800 mcg if adequate pain relief is not achieved with the starting dose of 100 mcg for all patients."

Launch • Demo Pain • Pain

Nasal Fentanyl and Buccal Midazolam for Dying Patients (clinicaltrials.gov) - P4; N=20; Recruiting; Sponsor: Gloucestershire Hospitals NHS Foundation Trust; Initiation date: Apr 2014 ➔ Jan 2017; Trial primary completion date: Apr 2015 ➔ Jan 2018

Trial initiation date • Trial primary completion date • Biosimilar • Oncology • Pain

Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying. (PubMed, BMJ Support Palliat Care) - P4 | "Study participation in a hospice population of the dying was acceptable. The results will help guide future community study planning."

Clinical • Journal

"1. Emergency ESWL if access (and nil contraindications) + IV / nasal fentanyl on table (as per @NICEComms) OR 2. Primary URS + stent Depends on #access to #surgery! #urology" (@DrDRW)

Effectiveness of fentanyl pectin nasal citrate in controlling episodes of breakthrough cancer pain triggered by routine radiotherapy procedures. (PubMed, Clin Transl Oncol) - "In our knowledge, our study is the one of highest recruitment, and with the fastest response of BTCP treated with FPNS reported in advanced cancer patients undergoing radiotherapy. FPNS has proven to be highly effective in reducing the intensity of procedural BTCP in a very short period of time."

Journal

Fentanyl nasal spray in a patient with end-stage COPD and severe chronic breathlessness. (PubMed, Breathe (Sheff)) - "Prescription of fentanyl nasal spray for breathlessness should only be done as part of palliative treatment and requires close follow-up. http://bit.ly/2YdOjJ1."

Clinical • Journal

Transmucosal fentanyl administration: sublingual, buccal, nasal - all the same? Treatment of breakthrough cancer pain (PubMed, MMW Fortschr Med) - "Tablets with an applicator (lozenge), sublingual and buccal tablets, as well as a buccal film are available for the oral transmucosal administration of fentanyl; there is an aqueous fentanyl nasal spray and a pectin-rich nasal spray for nasal transmucosal administration. The individual preparations differ considerably with regard to their pharmacological (e.g. bioavailability, cand t) and patient-relevant parameters (e.g. onset of action, potency and duration of effect). Fentanyl nasal spray is superior to the other forms of administration in terms of rapid onset of action and clinically relevant pain reduction and can thus be recommended as a treatment option for rapidly evolving and/or spontaneously occurring breakthrough cancer pain."

Journal

Factors influencing the use of opioids for breakthrough cancer pain: a secondary analysis of the IOPS-MS study. (PubMed, Eur J Pain) - "The use of opioids for breakthough cancer pain was effective and safe in a large sample of advanced cancer patients recruited in different stages of disease and settings. Doses of opioids proportional to opioid doses used for background analgesia, seem to guarantee both effectiveness and safety."

Journal

Comparison of analgesia, adverse effects, and quality of life in cancer patients during treatment of procedural pain with intravenous morphine, fentanyl nasal spray, and fentanyl buccal tablets. (PubMed, Cancer Manag Res) - "Patients treated with intranasal and buccal fentanyl had higher physical functioning and were more active. In the treatment of procedural pain induced by nursing procedures in cancer patients, intravenous morphine and rapid-onset fentanyl show similarly high analgesic efficacy, with good tolerance of treatment and improvement in QoL."

Adverse events • Clinical • HEOR • Journal