FDA approves Noxafil for oropharyngeal candidiasis

Journal of Drugs in Dermatology, Jan, 2007 by Marissa Heller

Schering-Plough Corporation recently announced that its product Noxafil has been approved by the FDA for the treatment of Oropharyngeal Candidiasis. Noxafil Oral Suspension, or posaconazole, is a triazole antifungal that had previously been approved for the prevention of invasive Aspergillus and Candida infections in immunocompromised patients.

This new approval is based on results from both a randomized, controlled study in patients with HIV with oropharyngeal candidiasis that compared posaconazole to fluconazole, as well as a study of posaconazole in patients with HIV with oropharyngeal candidiasis who had previously been unresponsive to fluconazole or itraconazole. In both studies, Noxafil was well-tolerated and the most common observed serious adverse effects were predominantly hepatic reactions. Of note, Noxafil is contraindicated in patients who are concomitantly taking a CYP3A4 substrate, as it may increase concentrations of these medications.