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.

OPC is an vocalized fungal infection most common in individuals with weakened unsusceptible systems - particularly those with HIV/AIDS and those undergoing steady cancer treatments. OPC is a disruptive ready that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, pain, aflame and/or altered taste.

Oravig is approved in 26 countries and is currently being marketed in several EU territories including France, Germany and the UK under the merchandising honour Loramyc. Under an limited licensing agreement with BioAlliance Pharma, Strativa received the upper-class US commercialization rights to Oravig (miconazole) buccal tablets. Under the terms of the agreement, the FDA mandate triggered a $20 million milestone pay from Strativa to BioAlliance, for add up to milestone payments to date in the amount of $35 million. In ell to royalties on sales, BioAlliance may walk off milestone payments on future sales.

Indication and Important Safety Information for Oravig. Oravig (miconazole) is indicated for the particular therapy of oropharyngeal candidiasis (OPC) in adults. Oravig (miconazole) is a buccal troche designed to adhere to the gum. Patients should be advised not to crush, chew, or dispatch the tablet.

During clinical trials, the most mean adverse events (greater than or equal to 2%) reported with Oravig were diarrhea (6,0%), nausea (4,6%), nuisance (5,0%), dysgeusia (2,9%), topmost abdominal pain (2,5%), and vomiting (2,5%). Oravig is contraindicated in patients with a known hypersensitivity to miconazole, out protein concentrate, or any other component of the product.

Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the provision of miconazole. Discontinue Oravig when at the start with sign of hypersensitivity. There is no communication regarding cross-hypersensitivity between miconazole and other azole agents reviews. Monitor patients with a the of hypersensitivity to azoles.