FDA Approves First Localized Oral Miconazole Therapy for Thrush

Yael Waknine

April 20, 2010

April 20, 2010 — The US Food and Drug Administration (FDA) has approved the first and only localized oral miconazole therapy (Oravig, Strativa Pharmaceuticals, under license from BioAlliance Pharma SA). The 50-mg buccal tablets are indicated for the treatment of oropharyngeal candidiasis, also known as thrush, in patients aged 16 years and older.

Thrush is an oral fungal infection that occurs most commonly in people with weakened immune systems, particularly those with HIV/AIDS or undergoing certain cancer treatments. Symptoms include oral soreness, pain, burning, and/or altered taste.

Miconazole buccal tablets represent a convenient once-daily treatment option with minimal systemic effects. Flavorless and odorless, the product adheres to the gum and delivers miconazole directly to the site of infection.

FDA approval was based in part on data from a multinational pivotal phase 3 clinical trial (n = 577) showing that treatment with once-daily miconazole buccal tablets was similarly effective to 5 daily clotrimazole troches (Mycelex, Bayer) for resolving thrush in HIV-positive patients.

A second phase 3 study (n = 282) demonstrated that miconazole buccal tablets are safe and effective in patients with reduced salivary flow secondary to radiotherapy for head and neck cancer.

Adverse events most commonly associated with localized miconazole therapy included diarrhea (6.0%), nausea (4.6%), headache (5.0%), dysgeusia (2.9%), upper abdominal pain (2.5%), and vomiting (2.5%).

Miconazole buccal tablets should not be used in patients with known hypersensitivity to miconazole, milk protein concentrate, or other product components. Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with miconazole therapy, and treatment should be discontinued immediately if these occur. Because there is no information regarding cross-hypersensitivity with miconazole, patients with a history of hypersensitivity to other azoles should be monitored.

Miconazole buccal tablets previously were approved for use in 26 countries and are currently being marketed in several European Union territories as Loramyc.


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