BioAlliance has announced that it will begin Phase I clinical trials for Fentanyl Lauriad, a new treatment for chronic cancer-based pain, after receiving approval from the French Drug Agency (AFSSaPS).
A Phase II clinical trial application for Clonidine Lauriad has also been submitted to the French Drug Agency for patient recruitment by the end of 2010.
BioAlliance Pharma president and CEO Dominique Costantini said that BioAlliance is accelerating the development of supportive care products in oncology, such as the treatment of chronic pain and mucositis that are frequent complications of cancer and its treatments.
The new clinical trial will evaluate the plasma pharmacokinetic parameters of Fentanyl Lauriad in healthy volunteers and is expected to be complete before the end of 2009.
Fentanyl Lauriad is based on the proprietary muco-adhesive technology already validated with Loramyc, BioAlliance’s already marketed drug, and with acyclovir Lauriad.
Clonidine Lauriad is the fourth product using the same innovative technology and is being developed for the treatment of oral mucositis.