Lazanda (fentanyl) / Assertio, Kyowa Kirin 
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 4 Diseases   0 Trials   0 Trials   70 News 
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    PK/PD data, Review, Journal:  Clinical and pharmacokinetics overview of intranasal administration of fentanyl. (Pubmed Central) -  Dec 25, 2023   
    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
  • ||||||||||  Journal:  Opioids for pain. (Pubmed Central) -  Dec 22, 2022   
    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 No abstract available
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Hakko Kirin, Rapinyl (fentanyl) / Kyowa Kirin, Orexo, Zydus Cadila
    Journal:  The prevalence of off-label prescribing of transmucosal immediate-release fentanyl in France. (Pubmed Central) -  May 26, 2022   
    The prevalence of off-label prescribing of TIRF in France is extremely high. A field survey is now needed 1) to better understand why TIRF is used in conditions not indicated in its marketing authorization, and in what clinical situations, and 2) to determine whether the benefit/risk ratio of such use is favorable.
  • ||||||||||  Duragesic (fentanyl) / J&J
    Clinical, Journal:  Breakthrough pain in patients with head & neck cancer. A secondary analysis of IOPS MS study. (Pubmed Central) -  Jul 7, 2020   
    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.
  • ||||||||||  fentanyl citrate / generics
    Journal:  Transmucosal fentanyl administration: sublingual, buccal, nasal - all the same? Treatment of breakthrough cancer pain (Pubmed Central) -  Aug 15, 2019   
    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.
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Enrollment change, Trial termination:  Lazanda in Cancer Patients Receiving Palliative Radiation (clinicaltrials.gov) -  Mar 20, 2018   
    P2,  N=6, Terminated, 
    N=120 --> 25 N=15 --> 6 | Recruiting --> Terminated; PI is leaving UCSD
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Trial initiation date:  Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) -  Jan 11, 2018   
    P4,  N=3, Terminated, 
    N=15 --> 6 | Recruiting --> Terminated; PI is leaving UCSD Initiation date: Feb 2013 --> Jan 2014
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Instanyl (fentanyl) / Takeda
    Trial primary completion date:  Safety of Intranasal Fentanyl (PecFent (clinicaltrials.gov) -  Oct 26, 2017   
    P2/3,  N=60, Recruiting, 
    The placebo effect was substantial, which needs to be factored in future study designs. Trial primary completion date: Sep 2017 --> Dec 2017
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Instanyl (fentanyl) / Takeda
    Trial primary completion date:  Safety of Intranasal Fentanyl (PecFent (clinicaltrials.gov) -  May 3, 2017   
    P2/3,  N=60, Recruiting, 
    Recruiting --> Completed Trial primary completion date: Mar 2017 --> Sep 2017
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Enrollment open:  Lazanda in Cancer Patients Receiving Palliative Radiation (clinicaltrials.gov) -  May 3, 2017   
    P2,  N=15, Recruiting, 
    Trial primary completion date: Mar 2017 --> Sep 2017 Not yet recruiting --> Recruiting
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Epistatus (midazolam oromucosal solution) / Veriton Pharma
    Trial initiation date, Trial primary completion date:  Nasal Fentanyl and Buccal Midazolam for Dying Patients (clinicaltrials.gov) -  Apr 18, 2017   
    P4,  N=20, Recruiting, 
    Not yet recruiting --> Recruiting Initiation date: Apr 2014 --> Jan 2017 | Trial primary completion date: Apr 2015 --> Jan 2018
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Enrollment change, Trial initiation date, Trial termination, Trial primary completion date:  Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) -  Jan 23, 2017   
    P4,  N=3, Terminated, 
    Initiation date: Apr 2014 --> Jan 2017 | Trial primary completion date: Apr 2015 --> Jan 2018 N=60 --> 3 | Initiation date: Jan 2014 --> Feb 2013 | Suspended --> Terminated | Trial primary completion date: Jan 2017 --> Oct 2014
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Instanyl (fentanyl) / Takeda
    Enrollment open:  Safety of Intranasal Fentanyl (PecFent (clinicaltrials.gov) -  May 27, 2015   
    P2/3,  N=60, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Trial suspension, Trial primary completion date:  Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) -  Feb 10, 2015   
    P4,  N=60, Suspended, 
    Not yet recruiting --> Recruiting Terminated --> Suspended | Trial primary completion date: Jan 2016 --> Jan 2017
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Instanyl (fentanyl) / Takeda
    New P2/3 trial:  Safety of Intranasal Fentanyl (PecFent (clinicaltrials.gov) -  Nov 24, 2014   
    P2/3,  N=60, Not yet recruiting, 
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Trial primary completion date:  Intranasal Fentanyl for Management of Pain Associated With Cystoscopic Procedures (clinicaltrials.gov) -  Nov 12, 2014   
    P1,  N=20, Recruiting, 
    Terminated --> Suspended | Trial primary completion date: Jan 2016 --> Jan 2017 Trial primary completion date: Feb 2014 --> Jul 2015
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Enrollment change, Trial termination:  Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) -  Oct 27, 2014   
    P4,  N=3, Terminated, 
    Trial primary completion date: Feb 2014 --> Jul 2015 N=60 --> 3 | Recruiting --> Terminated
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin
    Enrollment open:  Fentanyl for Breakthrough Pain in the Emergency Department (clinicaltrials.gov) -  Jan 9, 2014   
    P4,  N=60, Recruiting, 
    Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2016 --> Apr 2017 Not yet recruiting --> Recruiting
  • ||||||||||  Lazanda (fentanyl) / Assertio, Kyowa Kirin, Epistatus (midazolam oromucosal solution) / Veriton Pharma
    New P4 trial:  Nasal Fentanyl and Buccal Midazolam for Dying Patients (clinicaltrials.gov) -  Dec 9, 2013   
    P4,  N=20, Not yet recruiting, 
  • ||||||||||  Trial termination:  Cycling of Sedative Infusions in Critically Ill Pediatric Patients (clinicaltrials.gov) -  Dec 5, 2012   
    P=N/A,  N=120, Terminated, 
    Active, not recruiting --> Completed Suspended --> Terminated; Unable to adequately enroll over a reasonable enrollment period.