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New Formulation: Miconazole buccal tablets (Oravig) was approved in April 2010 for the local treatment of oropharyngeal candidiasis in adults.
Miconazole buccal tablets (MBTs) are indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. Miconazole, an –azole antifungal, inhibits the enzyme cytochrome P450 14-α-demethylase. This inhibition leads to decreased ergosterol synthesis, an essential component of the fungal cell membrane, and ultimately disruption of fungal growth.
Efficacy. MBTs have been studied using a randomized trial design in both HIV-1 positive and head and neck cancer patients who had received radiation therapy. In these trials, patients (typically infected with Candida albicans or Candida tropicalis) were administered MBT 50 mg once daily for 14 consecutive days. In the HIV-1 positive trial, MBT therapy (n=290) was compared with clotrimazole troches 10 mg, 5 times per day for 14 days (n=287). Clinical cure defined as a complete resolution of both signs and symptoms of OPC (at days 17–22), was similar between groups (difference in clinical cure rates was –4.5%, 95% CI –12.4% to 3.4%). Similarly in head and neck cancer patients who had received radiation therapy, those receiving MBT (n=148) had similar efficacy (complete or partial response) to those receiving miconazole oral gel 125 mg 4 times daily (n=146) for 14 days (53.4% to 46.6%, respectively).
Safety. Overall, 43.5% of patients experienced at least 1 adverse event. The most common ones reported in the overall safety database of 480 patients who received MBTs included diarrhea (6.0%), nausea (4.6%), upper abdominal pain (2.5%), vomiting (2.5%), infections (11.9%), and headache (5.0%).