BioAlliance Pharma SA (Euronext Paris – BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announced positive preliminary results from the first Phase I trial of fentanyl Lauriad®.
This first randomized, single-centre trial in healthy volunteers has evaluated the pharmacokinetics of a single application of 2 different innovative muco-adhesive formulations of fentanyl Lauriad®. The fentanyl was detected in the plasma soon after the application of each formulation and plasma concentrations remained stable over the next 24 hours, with low intersubject variability, especially for one of the two formulations that will be used for subsequent clinical development. Both muco-adhesive buccal formulations displayed a good local safety profile. These preliminary results suggest that a single daily application of fentanyl Lauriad® may provide effective relief of severe chronic pain in cancer patients. The company is planning to perform a second pharmacokinetic repeated-dose study by the end of the year.
“The success of this first Phase I clinical trial with fentanyl Lauriad® relies on our original know-how in mucosal drug delivery”, explained Dominique Costantini, BioAlliance Pharma’s President and CEO. “The Lauriad® technology has been extended to fentanyl and enables molecules which can cross the mucosa to remain in the body for long periods. This is a very important step on the path to clinical development for fentanyl Lauriad®”.
About this first Phase I trial of fentanyl Lauriad®
This clinical trial was performed in healthy volunteers who were successively administered two innovative formulations one week apart according to a randomized design. The objective was to obtain stable fentanyl plasma concentrations over several hours. Fentanyl has already been shown to be systemically absorbed through the mucosal route leading to the development of fentanyl-based treatments for severe, acute pain. With the patented Lauriad® formulation, fentanyl is rapidly and continuously released in the oral mucosa and systemically absorbed. This concept of a sustained release addresses the treatment of cancer chronic pain.