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Home » FDA ACCEPTS IND FROM BIOALLIANCE FOR PHASE III TRIAL
FDA ACCEPTS IND FROM BIOALLIANCE FOR PHASE III TRIAL
September 7, 2005
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.
KEYWORDS Drug Pipeline Alert
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