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 remedying of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children stage 16 and older view homepage. Oravig is the commencement and only local, uttered medicine formulation of miconazole - an antifungal medication - approved for this use in the US.

Oravig, which adheres to the gum, utilizes innovative buccal slab technology enabling once-daily dosing that delivers miconazole undeviatingly at the local site of infection throughout the day with minimal systemic absorption definicion. Oravig is easy-to-use and provides patients with a flavorless, odorless and expedient treatment option that does not interfere with continuously activities such as eating and drinking.

Oravig will be offered in a 50 mg dosage strength and is expected to be close by in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall curing experience by bringing to market new products that fulfill perseverant needs," said John A MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients torture from thrush a proven effective treatment in a discreet and serviceable once-daily formulation".

The FDA approval was based on two pivotal Phase III clinical trials. The anything else study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates comparable to Mycelex Troche (clotrimazole) administered five times per date in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 sites in the United States, Canada, and South Africa. A lieutenant randomized, open-label, multicenter comparative bur conducted in 282 patients who underwent radiotherapy for go and neck cancer showed that Oravig is safe and effective in this patient population who often has reduced salivary flow.

OPC is an viva voce fungal infection most common in individuals with weakened immune systems - amazingly those with HIV/AIDS and those undergoing certain cancer treatments. OPC is a disruptive acclimate that results in lesions and inflammation in the mouth, and includes symptoms such as soreness, pain, burning 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 business pinpoint Loramyc. Under an exclusive licensing concurrence with BioAlliance Pharma, Strativa received the exclusive US commercialization rights to Oravig (miconazole) buccal tablets. Under the terms of the agreement, the FDA leave triggered a $20 million milestone pay from Strativa to BioAlliance, for total milestone payments to date in the amount of $35 million. In extension to royalties on sales, BioAlliance may receive milestone payments on to be to come sales.

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

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

Allergic reactions, including anaphylactic reactions and hypersensitivity, have been reported with the supplying of miconazole. Discontinue Oravig in two shakes of a lamb's tail at the first sign of hypersensitivity. There is no information regarding cross-hypersensitivity between miconazole and other azole agents gordonii. Monitor patients with a representation of hypersensitivity to azoles.