Shire announces results of Lialda analysis

Shire has announced the results from a multidisciplinary analysis of the drug release profiles of Lialda (mesalamine) compared to Asacol (mesalamine) as a treatment for ulcerative colitis.

The in vitro and in vivo data for the compounds were presented at a meeting of the American College of Gastroenterology.

Factors assessed included the transit and disintegration of tablets as well as tablet-coating thickness which could affect the consistent release of 5-aminosalicylate acid (5-ASA) in both therapies

The company noted the trial did not evaluate or compare the clinical efficacy of both compounds and the clinical significance of the results had not been established.

Srini Tenjarla, senior director of pharmaceutical sciences at Shire, said: “Previous studies have demonstrated that Lialda is an effective and generally well-tolerated treatment for patients who have active, mild-to-moderate ulcerative colitis.”

He added the time of initial release of 5-ASA in the colon and its duration of release is important when treating ulcerative colitis, while Lialda shows a steady release of the acid throughout the colon.

In June 2008, Shire announced the publication of a long-term safety and tolerability study of Lialda that month’s issue of Gut, the journal of the British Society of Gastroenterology.