NOXAFIL ORAL SUSPENSION SIGNIFICANTLY REDUCES INVASIVE FUNGAL INFECTIONS
Schering-Plough has reported results of a new clinical study demonstrating that
its investigational antifungal agent Noxafil (posaconazole) oral suspension,
compared to fluconazole, significantly reduced the incidence of aspergillosis,
a serious fungal infection associated with a high rate of mortality, as well
as serious invasive fungal infections (IFIs) overall during treatment, in allogeneic
hematopoietic stem cell transplant recipients with graft-versus-host disease.
In this patient population, Noxafil decreased deaths due to IFIs compared to
fluconazole, while demonstrating a similar safety profile. Both drugs were well-tolerated
in this study.
In this large, prospective, double-blind, double-dummy, controlled study, a total of 600 patients from 90 centers worldwide were randomized to receive Noxafil oral suspension 200 mg three times daily or fluconazole 400 mg capsules once daily for a maximum of 112 days, or until a protocol specified endpoint was reached. All patients were monitored for fungal infection during the 112-day treatment phase and were followed for two months after completing treatment or after prematurely discontinuing therapy. Noxafil, compared to fluconazole, significantly reduced the incidence of aspergillosis, as well as invasive fungal infections overall in patients while on treatment. It also significantly reduced the incidence of aspergillosis during the 112-day study-specified primary time period.