The approval is based on results from two randomized, double-blind, placebo-controlled multi-center, multi-national studies totaling 562 adults in remission from ulcerative colitis (UC).
Apriso is a locally-acting aminosalicylate indicated for the maintenance of remission of UC adults. Additionally, Apriso is said to be 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, chief development officer of Salix, said: “Apriso is an important new once-daily treatment option that encourages compliance in UC patients and provides effective long-term protection from UC flare-ups. A major goal of UC therapy is to prevent relapse which may decrease the risk of disease progression.”