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ORAVIG

Last Updated: September 16, 2010

Manufacturer:

Strativa Pharmaceuticals

Pharmacological Class:

Azole antifungal.

Active Ingredient(s):

Miconazole 50mg; buccal tablet.

Indication(s):

Local treatment of oropharyngeal candidiasis.

Pharmacology:

Miconazole inhibits the enzyme cytochrome P450 14α-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. This antifungal is active against Candida albicans, C. parapsilosis and C. tropicalis.

Oravig buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves.

Clinical Trials:

Two multicenter, randomized trials were conducted to evaluate the safety and efficacy of Oravig buccal tablets in the local treatment of oropharyngeal candidiasis (OPC). The first trial was a double-blind, double-dummy study that compared Oravig 50mg once daily for 14 consecutive days (n=290) to clotrimazole troches 10mg 5 times per day for 14 days (n=287) in HIV-positive patients with OPC. Clinical cure was defined as complete resolution of both the signs and symptoms of OPC at the test of cure visit (days 17–22). Clinical cure rates showed Oravig to be comparable to clotrimazole troches (60.7% vs. 65.2%, respectively; difference in clinical cure rates was -4.5%, with 95% CI: -12.4%, 3.4%). In patients who relapsed (27.3% in the Oravig arm and 27.8% in the clotrimazole troches arm) the mean time to relapse was 15.3 days (SD 4.6) and 15.7 days (SD 6.6) for Oravig and clotrimazole, respectively. Mycological cure, defined as eradication of Candida species at the test of cure visit, was 27.2% for Oravig vs. 24.7% for clotrimazole.

A second, open-label comparative trial conducted in head and neck cancer patients who had received radiation therapy showed Oravig 50mg once daily to be non-inferior to miconazole oral gel 125mg four times daily for 14 days. 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. In patients who relapsed (18.9% for Oravig vs. 12.5% for miconazole oral gel), the mean time to relapse was 18.8 days (SD 16.3) and 20.6 days (SD 13.5), in the Oravig and miconazole oral gel group, respectively. Mycological cure was 44.6% vs. 53.4% for Oravig and miconazole oral gel, respectively.

Legal Classification:

Adults:

Do not crush, chew, or swallow. Alternate application site. Apply to upper gum region, hold in place for 30 seconds. ≥16yrs: 50mg once daily in the AM for 14 consecutive days.

Children:

<16yrs: not recommended.

Contraindication(s):

Allergy to milk protein concentrate.

Warnings/Precautions:

History of hypersensitivity to azoles; monitor and discontinue if allergic reactions develop. Hepatic impairment. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

May potentiate anticoagulant effects with warfarin (monitor PT, INR, evidence of bleeding). Caution with drugs metabolized by CYP2C9 and CYP3A4 (eg, oral hypoglycemics, phenytoin, ergot alkaloids).