Noxafil Approved for Treatment of Oropharyngeal Candidiasis

November 1, 2006

The FDA has approved Schering-Plough's novel triazole antifungal agent Noxafil (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole.

ROCKVILLE, Maryland--TheFDA has approved Schering-Plough'snovel triazole antifungal agent Noxafil(posaconazole) Oral Suspension for thetreatment of oropharyngeal candidiasis,including infections refractory to itraconazoleand/or fluconazole. The drugrecently received FDA approval for theprevention of invasive Aspergillus andCandida infections in patients 13 years ofage and older who are at high risk ofdeveloping these infections due to beingseverely immunocompromised, such ashematopoietic cell transplant recipientswith graft-vs-host disease or those withhematological malignancies with prolongedneutropenia from chemotherapy(see ONI October 2006, page 1).

The FDA approval of Noxafil for treatingoropharyngeal candidiasis is basedprimarily on the results of a randomized,controlled, evaluator-blinded clinicalstudy in HIV-infected patients that comparedNoxafil with fluconazole, as well asa noncomparative study of Noxafil inHIV-infected patients with oropharyngealcandidiasis refractory to treatmentwith fluconazole or itraconazole.