FDA ACCEPTS IND FROM BIOALLIANCE FOR PHASE III TRIAL

BioAlliance Pharma has announced that its investigational new drug application to conduct a pivotal Phase III clinical trial of the antifungal agent miconazole Lauriad has been accepted by the FDA.

Miconazole Lauriad is a once-daily 50 mg extended-release bioadhesive buccal tablet being investigated as a first-line local treatment for oropharyngeal candidiasis (OPC), an oral fungus. OPC infections are frequent within immunocompromised populations, such as those represented by cancer therapy, HIV-infection, ICU and transplant patients, diabetes mellitus and denture use. The trial will be conducted in HIV-positive patients.