Source: www.biospace.com Author: press release Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole – an antifungal medication – approved for this use in the U.S. Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly 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 convenient treatment option that does not interfere with daily activities such as eating and drinking. Oravig will be offered in a 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall treatment experience by bringing to market new products that fulfill patient needs," said John A. MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients suffering from thrush a proven effective treatment in a discreet and convenient once-daily formulation." The FDA approval was based on two pivotal Phase III clinical trials. The first study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex® Troche (clotrimazole) administered five times per day in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 [...]