Clinical Trial Research

RHEI Pharmaceuticals Announces the Initiation of the Final Clinical Study for Approval of Tibozole in China

Published in Medical Letter on the CDC and FDA, December 28th, 2008

RHEI Pharmaceuticals, Inc. announced that the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, has been initiated in China. This will be the last clinical trial conducted for submission of the New Drug Application (NDA) to the State Food and Drug Administration (SFDA) in China. RHEI licensed Tibozole from Tibotec, a Johnson and Johnson company.

This study will compare Tibozole to Sporanox (itraconazole) and include approximately 350 patients who have oral candidiasis. Patients will be treated once daily for a maximum of 14 days. The endpoint is clinical and mycological cure. The study is expected...

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Source: Medical Letter on the CDC and FDA (2008-12-28)

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