Oravig (miconazole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 2010

Specific Treatments:

oropharyngeal candidiasis

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General Information

Oravig contains the active ingredient miconazole, an imidazole antifungal agent. Miconazole works by inhibiting the synthesis of ergosterol, a critical component of fungal cell membranes.

Oravig is specifically indicated for the local treatment of oropharyngeal candidiasis in adults.

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 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 5 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 17-22). The clinical cure was reported by 60.7% of subjects in the Oravig arm and 65.2% of the Clotrimazole troches arm. Mycological cure was defined as eradication (i.e., no yeast isolates) of Candida species at the TOC visit (days 17-22). Mycological cure was reported by 27.2% of the Oraig arm and 24.% of the Clotrimazole troches arm.
Study in Head and Neck Cancer Patients
This open-label, randomized, multicenter trial comparing 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 2 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% of the Oravig arm and 46.6% of the Miconazole oral gel arm. Mycological cure was reported in 44.6% of the Oravig arm and 53.4% of the Miconazole oral gel arm.

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

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.

Literature References

Bensadoun RJ, Daoud J, El Gueddari B, Bastit L, Gourmet R, Rosikon A, Allavena C, Céruse P, Calais G, Attali P Comparison of the efficacy and safety of miconazole 50-mg mucoadhesive buccal tablets with miconazole 500-mg gel in the treatment of oropharyngeal candidiasis: a prospective, randomized, single-blind, multicenter, comparative, phase III trial in patients treated with radiotherapy for head and neck cancer. Cancer 2008 Jan 1;112(1):204-11

Van Roey J, Haxaire M, Kamya M, Lwanga I, Katabira E Comparative efficacy of topical therapy with a slow-release mucoadhesive buccal tablet containing miconazole nitrate versus systemic therapy with ketoconazole in HIV-positive patients with oropharyngeal candidiasis. Journal of Acquired Immune Deficiency Syndromes 2004 Feb 1;35(2):144-50

Additional Information

For additional information regarding Oravig or oropharyngeal candidiasis, please visit the Oravig web page.