WITHDRAWN: Opioids for the management of breakthrough pain in cancer patients.
CONCLUSIONS: Oral and nasal transmucosal fentanyl is an effective treatment in the management of breakthrough pain. The RCT literature for the management of breakthrough pain is relatively small. Given the importance of this subject, more trials, including head-to-head comparisons of the available transmucosal fentanyl formulations are required. PMID: 26275024 [PubMed - as supplied by publisher] (Source: Cochrane Database of Systematic Reviews)
Source: Cochrane Database of Systematic Reviews - August 14, 2015 Category: Journals (General) Authors: Zeppetella G, Davies AN Tags: Cochrane Database Syst Rev Source Type: research

Interaction of fentanyl with various cyclodextrins in aqueous solutions
ConclusionsThis study revealed that hydrophilic β‐CD derivatives, such as G1‐β‐CD, could be useful pharmaceutical additives for oral mucosal formulations because of the improved fentanyl base solubility via inclusion complexation. (Source: Journal of Pharmacy and Pharmacology)
Source: Journal of Pharmacy and Pharmacology - June 16, 2015 Category: Drugs & Pharmacology Authors: Noriko Ogawa, Takayuki Furuishi, Hiromasa Nagase, Tomohiro Endo, Chisato Takahashi, Hiromitsu Yamamoto, Yoshiaki Kawashima, Thorsteinn Loftsson, Masaru Kobayashi, Haruhisa Ueda Tags: Research Paper Source Type: research

A Randomized Crossover Clinical Trial to Evaluate the Efficacy of Oral Transmucosal Fentanyl Citrate in the Treatment of Dyspnea on Exertion in Patients With Advanced Cancer
Conclusion: It could not be demonstrated that the OTFC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all the patients. (Source: American Journal of Hospice and Palliative Medicine)
Source: American Journal of Hospice and Palliative Medicine - April 12, 2015 Category: Palliative Care Authors: Pinna, M. A. C., Bruera, E., Moralo, M. J. R., Correas, M. A. S., Vargas, R. M. Tags: Original Articles Source Type: research

Reduction in Medication Errors: The Fentora Case Study
Fentora (fentanyl citrate) is an analgesic opioid used in the management of breakthrough pain in adult cancer patients. Numerous reports of medication errors had been reported since the product’s launch in 2006, 74% of which were prescribing errors. Subsequent to the initiation of a risk evaluation and mitigation strategy (REMS) by FDA and the sponsor in 2011, reports of prescribing errors dropped rapidly. It is likely the REMS had a significant impact on the safe use of this important product. While further data from subsequent years would be needed to confirm this hypothesis, this is one of the first reports of an ...
Source: Therapeutic Innovation and Regulatory Science - January 8, 2015 Category: Drugs & Pharmacology Authors: Palvatla, G. R., Martin, I. G. Tags: Product Safety Source Type: research

Hydrogen Profiles of Dobutamine Hydrochloride and Fentanyl Citrate Solutions According to Intravenous Administration Systems, Temperature, and Luminosity Conditions
Factors such as temperature, light exposure, drug concentration, ionic strength, time of infusion, and duration of drug association can influence the effectiveness of pharmacological solutions, which can compromise the solutions' quality, resulting in unstable solutions and drug incompatibility. The aim of this study was to determine the pH of solutions of dobutamine hydrochloride, fentanyl citrate, and their combination in 5% dextrose in water (D5W) under various light exposures and temperature conditions over time. The analysis was performed by measuring the pH of the substances in both pharmacological (commercial) prepa...
Source: Journal of Infusion Nursing - September 1, 2014 Category: Nursing Tags: Features Source Type: research

Safety and efficacy of oral transmucosal fentanyl citrate compared to morphine sulphate immediate release tablet in management of breakthrough cancer pain.
CONCLUSIONS: OTFC was found to provide faster onset of analgesic effect than immediate release oral morphine in management of breakthrough cancer pain. PMID: 25191003 [PubMed] (Source: Pain Physician)
Source: Pain Physician - September 1, 2014 Category: Anesthesiology Authors: Bhatnagar S, Devi S, Vinod N, Jain P, Durgaprasad G, Maroo SH, Patel KR Tags: Indian J Palliat Care Source Type: research

Safety and efficacy of oral transmucosal fentanyl citrate compared to morphine sulphate immediate release tablet in management of breakthrough cancer pain
Conclusions: OTFC was found to provide faster onset of analgesic effect than immediate release oral morphine in management of breakthrough cancer pain. (Source: Indian Journal of Palliative Care)
Source: Indian Journal of Palliative Care - August 8, 2014 Category: Palliative Care Authors: Sushma BhatnagarSaraswathi DeviNK VinodPN JainG DurgaprasadSanjaykumar H MarooKetan R Patel Source Type: research

A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer.
PMID: 25048312 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - July 18, 2014 Category: Drugs & Pharmacology Authors: Gombert-Handoko KB Tags: Clin Ther Source Type: research

A Randomized Crossover Clinical Trial to Evaluate the Efficacy of Oral Transmucosal Fentanyl Citrate in the Treatment of Dyspnea on Exertion in Patients With Advanced Cancer
I have read with interest the article “Fentanyl for the Relief of Refractory Breathlessness: A Systematic Review.” Our research group has carried out a randomized, double-blind, crossover clinical trial to evaluate the efficacy of oral transmucosal fentanyl citrate (OTFC; 200–400 μg) in dyspnea on exertion after the completion of a six-minute walk test (6MWT) (EudraCT no. 2012-021399-26). All patients were attended in 2011 by the Palliative Care Supportive Team from Badajoz, Spain. On Visit 1, patients were randomly assigned to one of the two treatment groups, and on the second visit, the patients who had been recei...
Source: Journal of Pain and Symptom Management - March 31, 2014 Category: Palliative Care Authors: Miguel Ángel Cuervo Pinna Tags: Letters Source Type: research

A Randomized, Placebo-Controlled Study of a New Sublingual Formulation of Fentanyl Citrate (Fentanyl Ethypharm) for Breakthrough Pain in Opioid-Treated Patients With Cancer.
CONCLUSIONS: This newly developed galenic formulation with a higher early systemic exposure and a shorter Tmax compared with oral transmucosal fentanyl citrate makes FE a particularly suitable formulation for the management of BTP in opioid-treated cancer patients due to the very rapid onset of action. FE provided significant improvement in pain intensity of BTP compared with placebo as early as 6 minutes' postadministration with a sustained effect over 60 minutes. FE was well tolerated by patients. ClinicalTrials.gov identifier: NCT 01842893. PMID: 24508417 [PubMed - as supplied by publisher] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - February 5, 2014 Category: Drugs & Pharmacology Authors: Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F, on Behalf of the ETHYFYL Study Group Tags: Clin Ther Source Type: research

Efficacy of Sublingual Fentanyl vs. Oral Morphine for Cancer-Related Breakthrough Pain.
CONCLUSIONS: Administration of SLF might provide a more effective treatment option than oral morphine for BTcP. PMID: 24385406 [PubMed - as supplied by publisher] (Source: Advances in Therapy)
Source: Advances in Therapy - January 3, 2014 Category: Drugs & Pharmacology Authors: Velázquez Rivera I, Muñoz Garrido JC, García Velasco P, España Ximénez de Enciso I, Velázquez Clavarana L Tags: Adv Ther Source Type: research

A Randomized Crossover Clinical Trial to Evaluate the Efficacy of Oral Transmucosal Fentanyl Citrate in the Treatment of Dyspnea on Exertion in Patients With Advanced Cancer.
Conclusion:It could not be demonstrated that the OTFC improved exertion dyspnea in patients with advanced cancer. A placebo effect was observed in all the patients. PMID: 24259406 [PubMed - as supplied by publisher] (Source: The American Journal of Hospice and Palliative Care)
Source: The American Journal of Hospice and Palliative Care - November 20, 2013 Category: Palliative Care Authors: Pinna MA, Bruera E, Moralo MJ, Correas MA, Vargas RM Tags: Am J Hosp Palliat Care Source Type: research

Opioids for the management of breakthrough pain in cancer patients.
CONCLUSIONS: Oral and nasal transmucosal fentanyl is an effective treatment in the management of breakthrough pain. The RCT literature for the management of breakthrough pain is relatively small. Given the importance of this subject, more trials, including head-to-head comparisons of the available transmucosal fentanyl formulations are required. PMID: 24142465 [PubMed - as supplied by publisher] (Source: Cochrane Database of Systematic Reviews)
Source: Cochrane Database of Systematic Reviews - October 21, 2013 Category: Journals (General) Authors: Zeppetella G, Davies AN Tags: Cochrane Database Syst Rev Source Type: research

A Network Meta-Analysis of the Efficacy of Opioid Analgesics for the Management of Breakthrough Cancer Pain Episodes
Conclusion: From current evidence, although all BTCP medications provided pain relief within the time frames assessed, transmucosal fentanyl medications achieved a greater level of pain relief in a shorter time frame than placebo or oral morphine. (Source: Journal of Pain and Symptom Management)
Source: Journal of Pain and Symptom Management - August 26, 2013 Category: Palliative Care Authors: Giovambattista Zeppetella, Andrew Davies, Indra Eijgelshoven, Jeroen P. Jansen Tags: Review Article Source Type: research

Single-dose pharmacokinetics of fentanyl sublingual spray and oral transmucosal fentanyl citrate in healthy volunteers: a randomized crossover study.
CONCLUSIONS: Absorption of fentanyl in this study was faster and bioavailability was greater with FSS than with OTFC. The pharmacokinetic profile of the sublingual spray closely matches the duration of onset to pain intensity in a breakthrough cancer pain episode. These findings suggest that FSS is appropriate for the treatment of breakthrough cancer pain. ClinicalTrials.gov identifier: NCT01780233. PMID: 23497761 [PubMed - in process] (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 1, 2013 Category: Drugs & Pharmacology Authors: Parikh N, Goskonda V, Chavan A, Dillaha L Tags: Clin Ther Source Type: research