New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Coliti...(eks) and for the maintenance of remissio...),Health

Date:10/15/2007

eks) and for the maintenance of remission of UC (the indicated dosage is 1.6 g/day in divided doses). Asacol is a non-steroidal medication that belongs to the class of agents known as 5-aminosalicylic acids (5-ASAs) and is the number one most prescribed oral sulfa-free 5-ASA therapy for UC with more than 20 million prescriptions written since its introduction in 1992.(2,3)

Asacol was well-tolerated in clinical studies. Overall, the incidence of adverse events with Asacol was comparable to placebo. In pivotal clinical studies of mildly to moderately active UC, the most frequent adverse events reported for Asacol and placebo, respectively, were headache (35% vs. 36%), abdominal pain (18% vs. 14%), eructation (16% vs. 15%), pain (14% vs. 8%) and nausea (13% vs. 15%); for the maintenance of remission of UC, the most frequent adverse events were headache (50% vs. 50%), rhinitis (42% vs. 36%), diarrhea (35% vs. 50%), abdominal pain (32% vs. 44%) and flatulence (24% vs. 30%).

Asacol is contraindicated in patients with hypersensitivity to salicylates. Caution should be exercised when using Asacol in patients with known renal dysfunction or history of renal disease. It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol tablets and periodically while on Asacol therapy. Serious adverse events may occur with Asacol. Please visit http://www.Asacol.com/pdf/us-asacol.pdf for full prescribing information. Additional information about Asacol can be found by visiting http://www.Asacol.com.

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