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 therapy of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children period 16 and older pro extender di shek o. Oravig is the initially and only local, spoken medication formulation of miconazole - an antifungal medication - approved for this use in the US.

Oravig, which adheres to the gum, utilizes innovative buccal drop technology enabling once-daily dosing that delivers miconazole quickly at the specific area of infection throughout the epoch with minutest systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and helpful treatment option that does not interfere with constantly activities such as eating and drinking.

Oravig will be offered in a 50 mg dosage backbone and is expected to be available in retail pharmacies in the third section of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall healing experience by bringing to exchange new products that fulfill patient needs," said John A MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients agony from thrush a proven functioning remedying in a discreet and convenient once-daily formulation".

The FDA concurrence was based on two pivotal Phase III clinical trials. The in front study demonstrated that Oravig perfectly resolved signs and symptoms of OPC at rates similar to Mycelex Troche (clotrimazole) administered five times per broad daylight in HIV-positive patients. This randomized, double-blind, double-dummy dry run was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A two shakes randomized, open-label, multicenter comparative exploratory conducted in 282 patients who underwent radiotherapy for be in and neck cancer showed that Oravig is safe-deposit and striking in this patient population who often has reduced salivary flow.