A comparative randomized, open-label, multicenter study of the efficacy and safety of miconazole mucoadhesive tablets and miconazole gel in the treatment of oropharyngeal candidiasis

Introduction: SO-1105 is an oral mucosal adhesive tablet containing 50 mg of miconazole. It had been shown overseas that a once-daily application of the drug continues antifungal effect in the treatment of oropharyngeal candidiasis. We report the results of the phase 3 clinical study of this drug with miconazole gel as a control in Japan. Methods: The study included patients aged 20 years or older with oropharyngeal candidiasis who had oral lesions characterized by oropharyngeal candidiasis and whose fungi was confirmed by direct microscopic examination. The primary efficacy endpoint was the clinical cure rate on Day15 after 14 days of administration. The population analyzed for efficacy was per protocol set (PPS). Results: 120 subjects were included in PPS. In detail, 59 subjects were in the SO-1105 group (SO-1105 group) and 61 subjects were in the miconazole gel group (Gel group). For efficacy, the clinical cure rate on Day15 was 47.5% in SO-1105 group and 47.5% in Gel group, showing the similar efficacy between both groups. For safety, adverse drug reactions were observed in 29.0% of SO-1105 group and 24.6% of Gel group, showing the similar safety between both groups. Conclusion: The efficacy of SO-1105 was shown to be similar to that of miconazole gel. Meanwhile, SO-1105 is an adhesive tablet and is administered once-daily. For this, SO-1105 is expected to better compliance and useful drug for the elderly. Therefore, SO-1105 is considered to be widely used in clinical practice as one of the therapeutic drugs for oropharyngeal candidiasis.