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 - 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
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