BioAlliance Announces Phase I Trial for Fentanyl Lauriad® and the Submission of a Clonidine Lauriad® Phase II Clinical Trial Application
News Oct 13, 2009
BioAlliance Pharma SA has announced the approval from the French Drug Agency (AFSSaPS) to enter first Phase I clinical trial for Fentanyl Lauriad®.
This clinical trial will evaluate the plasma pharmacokinetic parameters of Fentanyl Lauriad® in healthy volunteers. It is expected to complete before end 2009.
Fentanyl Lauriad® is based on the proprietary muco-adhesive technology already validated with Loramyc®, BioAlliance already marketed drug, and with acyclovir Lauriad® positive Phase III clinical trial. This new sustained release product is dedicated to the treatment of cancer chronic pain.
Clonidine Lauriad®, the fourth product using the same technology, is being developed for the treatment of oral mucositis. A Phase II clinical trial application has been submitted to the French Drug Agency and the first patient should be recruited early 2010.
“BioAlliance confirms it is accelerating the development of supportive care products in oncology, such as the treatment of chronic pain and mucositis that are both frequent complications of cancer and its treatments”, added Dominique Costantini, President and CEO of BioAlliance Pharma.