Sosei's fentanyl spray product goes into Ph I in USA
Tokyo, Japan-based Sosei Group says that AD 923, a novel sublingual fentanyl spray for the treatment of cancer breakthrough pain, has entered into a Phase I comparative pharmacokinetic study in the USA under an Investigational New Drug regulatory submission.
The trial is a single center, open-label, single dose, cross-over study to investigate the comparative pharmacokinetics of AD923 against intravenous and oral transmucosal formulations of fentanyl in 24 healthy human volunteers.
Commenting on the progress, Sosei chief executive Shinichi Tamura said that "there is a major requirement for a simple ad manageable method of providing immediate-release fentanyl for the rapid relief of breakthrough pain which AD923 has been optimized to deliver."
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