Salix Pharmaceuticals, Ltd (RALEIGH, North Carolina), a company focused on prescription pharmaceutical products for the treatment of gastrointestinal diseases, announced that the US FDA has granted marketing approval for Apriso™ (mesalamine) extended-release capsules 0.375 g. Apriso is a locally-acting aminosalicylate (5-ASA) indicated for the maintenance of remission of ulcerative colitis (UC) in adults. Apriso is the first and only mesalamine product approved by the FDA for once-a-day dosing for the maintenance of remission of ulcerative colitis. Additionally, Apriso is the first and only 5-ASA with Intellicor™ extended-release delivery technology. Salix expects to launch Apriso to physicians during the first quarter of 2009.

The approval is based on results from two randomized, double-blind, placebo-controlled multicenter, multinational studies totaling 562 adults in remission from UC. In both studies, the proportion of patients who remained relapse-free at 6 months was greater for Apriso than for placebo. In these studies Apriso maintained remission for 6 months in 7 out of 10 UC patients and sustained improvement in rectal bleeding and bowel movement frequency.

Apriso’s Intellicor delivery system combines an enteric pH-dependent coating that provides for a delayed release starting at a pH of 6.0 and a polymer matrix core, which provides for extended release. This delivery technology is designed to distribute the active ingredient beginning in the small bowel and continuing throughout the colon. Unlike tablets, Apriso's gelatin outer capsule quickly dissolves in the stomach to disperse microgranules into the digestive tract. Next, a delayed-release coating on the microgranules dissolves at pH 6.0 or higher. Lastly, an inner polymer matrix core controls the extended release of mesalamine to provide drug distribution throughout affected areas. Previous generation pH-dependent 5-ASA treatment options provide for release of the active ingredient starting at a pH of 7.0. According to published data, many people never reach a pH of 7.0 in their small or large intestine.

Salix acquired rights to market Apriso in the US from Dr. Falk Pharma GmbH of Freiburg, Germany, one of the most recognized companies worldwide in gastroenterology. Mesalamine granules have been approved in Germany since 2001 for the treatment of symptoms related to inflammatory bowel disease. In addition, consistent with the FDA-approved labeling, once-daily dosing of mesalamine granules is currently approved via the mutual recognition procedure in Austria, Belgium, Denmark, Finland, Greece, Ireland, Luxemburg, Netherlands, Norway, Portugal, Sweden, Spain, and the UK.