APRISO(TM) first and only 5-ASA with Intellicor(TM) Extended-Release Delivery and 24-Hour Protection from Flare-Ups in a Once-Daily Dose

 

Salix Pharmaceuticals, Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for APRISO™ (mesalamine) extended-release capsules 0.375 g. APRISO is a locally-acting aminosalicylate 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. The Company expects to launch APRISO to physicians during the first quarter of 2009. APRISO is patent protected until 2018.

Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, Salix, stated, “APRISO is an important new once-daily treatment option that encourages compliance in ulcerative colitis patients and provides effective long-term protection from ulcerative colitis flare-ups. A major goal of UC therapy is to prevent relapse which may decrease the risk of disease progression. APRISO accomplishes this goal through the combination of an enteric pH-dependent coating which provides for a delayed release starting at a pH of 6.0 and a polymer matrix core, which provides for extended release. This patented delivery technology is designed to distribute the active ingredient beginning in the small bowel and continuing throughout the colon. 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. APRISO represents a new and important advancement in 5-ASA drug delivery.”