Pharmacology Update

Miconazole Buccal Tablets (Oravig™)

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationships to this field of study.

The FDA has approved a miconazole buccal tablet for the treatment of oropharyngeal candidiasis. This once-daily mucoadhesive buccal tablet provides slow release of the drug over the course of the day. The tablet is marketed by Strativa Pharmaceuticals as Oravig™.

Indications

Miconazole buccal tablets are indicated for the local treatment of oropharyngeal candidiasis in adults.1

Dosage

The buccal tablet should be placed to the gum region (with the round side facing the gum) once daily for 14 consecutive days.1 It should be applied in the morning after brushing the teeth and placed against the upper gum just above the incisor tooth and held in place for 30 seconds to ensure adhesion. The tablets should not be crushed, chewed, or swallowed. Chewing gum should be avoided, but food and drink can be taken normally. The application site should be alternated between the right and left sides of the mouth.

Miconazole buccal tablets are supplied as 50 mg tablets.

Potential Advantages

Miconazole buccal tablet is applied once daily compared to five times daily for clotrimazole troches.

Potential Disadvantages

Some Candida strains show reduced in vitro susceptibility to miconazole.1

Comments

Miconazole is an azole antifungal agent with in vitro activity against Candida albicans, Candida parapsilosis, and Candida tropicalis. The efficacy of the buccal tablets for the treatment of oropharyngeal candidiasis was shown in two studies, one in HIV-infected patients and in patients who were receiving radiotherapy for head and neck cancer.1,2 In both studies the infections were mainly caused by C. albicans (85% and 71%, respectively). In the first study, HIV patients with symptoms and microbiological documentation of oropharyngeal candidiasis were randomized to miconazole 50 mg daily for 14 days (n = 290) or clotrimazole troches 10 mg five times daily for 14 days (n = 287). Clinical cures (complete resolution of signs and symptoms) on days 17-22 were similar, 60.7% for miconazole and 65.2% for clotrimazole. The relapse rates (21-24 days after treatment completion) were also similar, 27.3% and 27.8%, respectively.

In the second study, adult patients who underwent radiation therapy for head and neck cancer with oropharyngeal candidiasis were randomized to miconazole buccal tablets (50 mg daily; n = 148) or miconazole oral gel (125 mg four times daily; n = 146) for 14 days. The complete response (complete disappearance of lesions) rates at day 14 were 50% for miconazole tablets compared to 43.8% for miconazole gel. The clinical relapse rates 14 days after the end of treatment were 18.9% and 12.5%, respectively. Patients with normal secretion responded better (100%) than those with reduced secretion (56.2%) or those with xerostomia (46.7%).2 The adhesion of the tablet to the gum was reported as very good, as 92.2% adhered for 6 hours and 61.1% for 12 hours.2 The tablets were generally well-tolerated with adverse events similar to the comparator; however, dysgeusia and ageusia were reported more frequently than the comparator (4.1% vs. 0% and 2.4% vs. 0.3%, respectively).

Clinical Implications

Oropharyngeal candidiasis is a common infection in immunosuppressed patients. The causative agent is generally Candida albicans. Oral fluconazole is considered the drug of choice,3 although topical therapy is often adequate for initial episodes. These include clotrimazole troches, nystatin suspension, or pastille or miconazole mucoadhesive tablets.

References

1. Oravig Product Information. Woodcliff Lake, NJ: Strativa Pharmaceuticals; April 2010.

2. Bensadoun RJ, et al. 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;112:204-211.

3. Kaplan JE, et al. Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. Recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR 2009;58(RR04):1-198. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5804a1.htm. Accessed May 6, 2010.