Shire has announced the approval of mesalamine with MMX technology (Lialda), indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. This product is the first once-daily oral formulation of mesalamine.
Mesalamines are a part of a drug class called aminosalicylates.
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Because the once-daily product contains the highest mesalamine dose per tablet (1.2 g), patients can take as few as two tablets once daily. Other mesalamines must be taken three to four times per day for a total of six to 16 tablets per day.
The FDA’s approval was based on the results of two phase 3 clinical studies. At doses of 2.4 g/day and 4.8 g/day, Lialda was effective in bringing about remission, compared with placebo, after eight weeks of treatment. The safety and effectiveness of Lialda beyond eight weeks have not been established.