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news.Rhei Pharmaceuticals, a specialty pharmaceutical company, has initiated the final clinical trial for Tibozole, a locally active antifungal with low dose miconazole in a patented mucoadhesive system, in China.
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This will be the last clinical trial conducted for submission of the new drug application (NDA) to the State Food and Drug Administration in China. Rhei licensed Tibozole from Tibotec, a Johnson and Johnson company.
This study will compare Tibozole to Sporanox 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 to continue through most of 2009, with an expected NDA filing in China toward the end of 2009.
Geert Cauwenbergh, CEO and chairman of Rhei Pharmaceuticals, said: If and when approved, Tibozole will be the first local azole treatment in the Chinese market for oral candidiasis. Although very effective, systemic drugs can have systemic side effects and drug interactions in certain patients, like those with cancer or AIDS, who are often on multiple other therapies.
Tibozole, a locally active azole derivative in a patented slow release mucoadhesive system, will be a welcome alternative when systemic absorption could create issues in patients.