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 duration 16 and older malebooster.men. Oravig is the triumph and only local, uttered instruction formulation of miconazole - an antifungal medication - approved for this use in the US.

Oravig, which adheres to the gum, utilizes innovative buccal headstone technology enabling once-daily dosing that delivers miconazole promptly at the provincial placement of infection throughout the heyday with slightest systemic absorption herbalm.top. Oravig is easy-to-use and provides patients with a flavorless, odorless and expedient therapy way out that does not trammel with commonplace activities such as eating and drinking.

Oravig will be offered in a 50 mg dosage tenaciousness and is expected to be at one's disposal in retail pharmacies in the third district of 2010. "The FDA green light of Oravig underscores Strativa's commitment to improving patients' overall care test by bringing to market new products that fulfill resolved needs," said John A MacPhee, President, Strativa Pharmaceuticals products. "Oravig offers patients affliction from thrush a proven efficient remedying in a discreet and helpful once-daily formulation".

The FDA approval was based on two radical Phase III clinical trials. The initial study demonstrated that Oravig clearly resolved signs and symptoms of OPC at rates alike to Mycelex Troche (clotrimazole) administered five times per period in HIV-positive patients. This randomized, double-blind, double-dummy plague was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A alternate randomized, open-label, multicenter comparative ass conducted in 282 patients who underwent radiotherapy for turn and neck cancer showed that Oravig is secure and real in this perseverant citizenry who often has reduced salivary flow.