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Two Studies Demonstrate Efficacy of Posaconazole in Preventing Aspergillus, Candida Fungal Infection
NOXAFIL is the first and only antifungal agent approved for the prevention of IFIs caused by Aspergillus.
"Prophylaxis is a commonly used therapeutic strategy, because the diagnosis of fungal infection is often delayed or difficult to establish with certainty, and a delay in antifungal treatment increases mortality," said Oliver Cornely, M.D., assistant professor, 1st Department for Internal Medicine, University of Cologne, Germany, and lead author of one of the published studies. "With posaconazole, we now can help prevent infections caused by the two most common pathogens, Aspergillus and Candida, before they occur."
More than 1,200 patients were enrolled in the studies, which demonstrated substantially fewer breakthrough Aspergillus infections with NOXAFIL prophylaxis versus the combined comparator drugs (fluconazole, itraconazole) in high-risk patients. These patients included hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies such as acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) with prolonged neutropenia from chemotherapy. In high-risk neutropenic patients, NOXAFIL prophylaxis was associated with decreased all-cause mortality versus the combined comparator drugs. In these studies, NOXAFIL demonstrated an adverse event profile comparable to fluconazole.
"There is an urgent need worldwide for establishing a standard of care for preventing life-threatening fungal infections in high-risk patients. Due to an expanding patient population, these infections are being seen more frequently and are a leading cause of death in these seriously ill patients," said Andrew J. Ullmann, M.D., attending physician for infectious diseases and hematology/oncology, 3rd Medical Department of the University Hospital of the Johannes Gutenberg University, Mainz, Germany, and lead author of one of the published studies. "These studies demonstrate that posaconazole prophylaxis provides effective, well-tolerated, preventive therapy, allowing physicians to focus on treating their patient's underlying disease."
About the Published Studies
Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients with Neutropenia (Cornely et al.): This randomized, multicenter, open-label study compared NOXAFIL Oral Suspension 200 mg three times daily (n=304) to fluconazole oral suspension 400 mg once daily (n=240) or itraconazole oral solution 200 mg twice daily (n=58) as prophylaxis against IFIs in neutropenic patients who were receiving cytotoxic chemotherapy for AML or MDS. In this study, NOXAFIL versus fluconazole/itraconazole demonstrated a reduction in proven and probable IFIs, the primary study endpoint (2 percent vs. 8 percent); significantly fewer breakthrough Aspergillus infections (1 percent vs. 7 percent); and improved overall survival.
Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host Disease (Ullmann et al.): This randomized, multicenter, double-blind study compared NOXAFIL Oral Suspension 200 mg three times daily (n=301) to fluconazole capsules 400 mg once daily (n=299) as prophylaxis against IFIs in allogeneic hematopoietic stem cell transplant (HSCT) recipients with graft- versus-host disease (GVHD). At the end of the fixed 112-day treatment period, NOXAFIL versus fluconazole demonstrated a reduction in proven/probable IFIs, the primary study endpoint (5 percent vs. 9 percent); a significant reduction in breakthrough Aspergillus infections (2 percent vs. 7 percent); and decreased IFI-related mortality.
NOXAFIL received marketing approval for prophylaxis in the United States and European Union (EU) in 2006, based primarily on the results of these two studies. NOXAFIL also was approved in the United States and EU in 2006 for the treatment of oropharyngeal candidiasis (OPC), a fungal infection of the mouth and throat, and in the EU in 2005 and Australia in 2006 for the treatment of certain IFIs in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents. NOXAFIL is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.
Source: Schering-Plough Corporation