Mechanism of Action

Oravig contains the active ingredient miconazole, an imidazole antifungal agent. Miconazole inhibits the enzyme cytochrome P450 14a-demethylase, which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell.

Side Effects

Adverse events associated with the use of Oravig may include, but are not limited to, the following:

Diarrhea

Headache

Nausea

Dysgeusia

Upper abdominal pain

Vomiting

Dosing/Administration

Oravig is supplied as a 50-mg buccal tablet designed to be dissolved in the gum region. The recommended dose is the application of one 50-mg buccal tablet to the upper gum region once daily for 14 consecutive days.

Clinical Trial Results

FDA Approval
The FDA approval of Oravig was based on the following studies:

HIV-Infected Patients
This randomized, double-blind, double-dummy, multicenter trial compared Oravig 50 mg once daily for 14 consecutive days (n = 290) with clotrimazole troches 10 mg five times per day for 14 days (n = 287) in HIV-positive patients. Clinical cure was defined as a complete resolution of both signs and symptoms of OPC at the test of cure (TOC) visit (days 17 to 22). The clinical cure was reported by 60.7 percent of subjects in the Oravig arm and 65.2 percent of the Clotrimazole troches arm. Mycological cure was defined as eradication (i.e., no yeast isolates) of Candida species at the TOC visit (days 17 to 22). Mycological cure was reported by 27.2 percent of the Oraig arm and 24 percent of the Clotrimazole troches arm.

Study in Head and Neck Cancer Patients
This open-label, randomized, multicenter trial compared Oravig 50 mg once daily for 14 days to miconazole oral gel 125 mg four times daily for 14 days in head and neck cancer patients who had received radiation therapy. Success rates of treatment at day 14 (defined as a complete [complete disappearance of candidiasis lesions] or partial response [improvement by at least two points of the score for extent of oral lesion compared with the score at day 1] based on a blind assessment) was reported in 53.4 percent of the Oravig arm and 46.6 percent of the Miconazole oral gel arm. Mycological cure was reported in 44.6 percent of the Oravig arm and 53.4 percent of the Miconazole oral gel arm.