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 care of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children time 16 and older remedies. Oravig is the beforehand and only local, said preparation formulation of miconazole - an antifungal medication - approved for this use in the US.

Oravig, which adheres to the gum, utilizes innovative buccal tombstone technology enabling once-daily dosing that delivers miconazole entirely at the nearby locale of infection throughout the daytime with minimum systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and handy treatment option that does not interfere with regularly activities such as eating and drinking.

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

The FDA confirmation was based on two pivotal Phase III clinical trials. The ahead study demonstrated that Oravig in toto resolved signs and symptoms of OPC at rates similar to Mycelex Troche (clotrimazole) administered five times per era in HIV-positive patients. This randomized, double-blind, double-dummy go was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A sec randomized, open-label, multicenter comparative trial run conducted in 282 patients who underwent radiotherapy for control and neck cancer showed that Oravig is non-toxic and operational in this patient population who often has reduced salivary flow.