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 curing of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children ripen 16 and older granny. Oravig is the senior and only local, enunciated medicament formulation of miconazole - an antifungal medication - approved for this use in the US.

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

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

The FDA approval was based on two pivotal Phase III clinical trials. The commencement study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates comparable to Mycelex Troche (clotrimazole) administered five times per period 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 aid randomized, open-label, multicenter comparative pain conducted in 282 patients who underwent radiotherapy for conduct and neck cancer showed that Oravig is safe and effective in this patient population who often has reduced salivary flow.