Treatment Of Oropharyngeal Candidiasis By Oravig (Miconazole) Buccal Tablets

Treatment Of Oropharyngeal Candidiasis By Oravig (Miconazole) Buccal Tablets.
Strativa Pharmaceuticals today announced that the US Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the healing of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children stage 16 and older. Oravig is the elementary and only local, voiced medicament formulation of miconazole - an antifungal medication - approved for this use in the US.

Oravig, which adheres to the gum, utilizes innovative buccal notebook technology enabling once-daily dosing that delivers miconazole precisely at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and accessible treatment option that does not interfere with regularly activities such as eating and drinking.

Oravig will be offered in a 50 mg dosage strength and is expected to be convenient in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall care experience by bringing to market new products that fulfill perseverant needs," said John A MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients torment from thrush a proven effective treatment in a discreet and commodious once-daily formulation".

The FDA approval was based on two pivotal Phase III clinical trials. The prime study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates nearly the same to Mycelex Troche (clotrimazole) administered five times per daylight in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A promote randomized, open-label, multicenter comparative headache conducted in 282 patients who underwent radiotherapy for control and neck cancer showed that Oravig is safe and effective in this patient population who often has reduced salivary flow.