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Analysis of Ulcerative Colitis (UC) Remission Rates from Long-term,Safety Study of Lialda (mesalamine) Presented at DDW

ee studies with LIALDA as sole therapy (abstract # T1297)

Another post-hoc analysis assessed long-term remission and relapse rates (secondary endpoints) of study 303. The analysis evaluated data from patients taking Lialda from all three studies: 301, 302, and 303. Patients in the parent studies (301 and 302) who did not achieve remission after eight weeks on Lialda were eligible for enrollment in the acute phase of study 303. In this acute phase, they were given a higher dose of Lialda (4.8g/day, once daily) for an additional eight weeks to induce remission. In total, 63.6 percent of patients (n=220/346) treated with Lialda for up to 16 weeks achieved remission.

Those patients, who achieved remission either in the parent studies (n=125), or the acute phase of study 303 (n=95), were allowed to enter the 12-month maintenance phase of study 303. Of the 220 patients who were in remission, 218 patients actually entered the maintenance phase.

A combined analysis of both long-term remission rates and relapse rates showed that of the patients who started on Lialda therapy, 56.6 percent achieved remission and remained relapse free for at least one year.

About LIALDA

LIALDA is part of a drug class called aminosalicylates, which contain 5-aminosalicyclic acid (5-ASA). 5-ASA is a well-established drug of choice and often a first-line treatment for UC. LIALDA is indicated for the induction of remission in patients with active, mild to moderate UC. The safety and efficacy of LIALDA have been established for up to eight weeks. LIALDA is the first new formulation in this class to be approved since 2000. LIALDA is the only ulcerative colitis treatment that utilizes MMX(TM) Technology. LIALDA with MMX Technology combines a pH dependent gastro-resistant coating, which delays the release of the medication to the colon (the site of the inflammation in ulcerative colitis), with a tablet core containing mesalamine with hydrophilic and lipophilic excipie
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