Miconazole Lauriad is a once-daily 50mg extended-release tablet being investigated as a first-line local treatment for oropharyngeal candidiasis (OPC), an oral fungus. OPC infections are frequent within patients whose immune systems have been compromised, such as those receiving cancer therapies or with HIV infection.
BioAlliance intends to initiate the phase III trial in the fourth quarter of 2005.
“FDA allowance of the miconazole Lauriad investigational new drug (IND) application for a pivotal phase III study represents an important milestone in our efforts to expand development of this first product in the Lauriad line,” said Dr Dominique Costantini, president and CEO of BioAlliance Pharma. “With our upcoming registration filing in the EU together with ongoing activities aimed at clinical development in Japan, we are rapidly expanding the potential global market for miconazole Lauriad and, as regulatory approvals are obtained, the possibility of a new treatment option for physicians and their patients suffering from OPC.”
The pivotal phase III trial will be conducted in HIV-positive patients. As part of the IND filing, BioAlliance submitted the results of two completed phase III trials conducted in the EU, one in head and neck cancer patients following radiotherapy and the other in HIV-positive patients.