Salix receives US appro for Apriso in UC

The USA's Salix Pharmaceuticals has received marketing approval for Apriso (mesalamine) extended-release capsules 0.375g, a locally-acting aminosalicylate for the maintenance of remission of ulcerative colitis in adults, from the Food and Drug Administration. The firm expects to launch the product during the first quarter of 2009.

The approval is based on results from two randomized, double-blind, placebo-controlled multicenter trials in 562 adults in remission from ulcerative colitis. The studies showed that Apriso maintained remission for six months in seven out of 10 patients and sustained improvement in rectal bleeding and bowel movement frequency.

Salix acquired rights to market Apriso in the USA from Germany's Dr Falk Pharma. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. The drug utilizes the company's Intellicor delivery system, which it says is the first and only device to combine delayed and extended 5-ASA release. Unlike tablets, Apriso's gelatin outer capsule quickly dissolves to disperse microgranules into the digestive tract, then a delayed-release coating on the microgranules is dispersed and lastly, an inner polymer matrix core controls the extended release of mesalamine.