KENILWORTH, N.J. -- Schering-Plough Corporation reported that the U.S. Food and Drug Administration (FDA) has approved NOXAFIL® (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis (OPC), including infections refractory to itraconazole and/or fluconazole. OPC is a fungal infection of the mouth and throat caused by the yeast Candida. NOXAFIL is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.
This approval follows the Sept. 15, 2006, FDA approval of NOXAFIL for prophylaxis (prevention) of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Invasive fungal infections are a leading cause of death in these high-risk populations.
The FDA approval of NOXAFIL for treating OPC is based primarily on the results of a randomized, controlled, evaluator-blinded clinical study in HIV-infected patients that compared NOXAFIL to fluconazole, as well as a non-comparative study of NOXAFIL in HIV-infected patients with OPC that was refractory to treatment with fluconazole or itraconazole.
Source: Schering-Plough Corporation