The European Phase III clinical trial is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using three Entocort EC?® (budesonide) 3 mg capsules dosed once daily (9 mg). The U.S. Phase III clinical trial is comparing a single tablet of budesonide MMX 6 mg or budesonide MMX 9 mg dosed once daily to placebo and to a reference arm using two Asacol?® (mesalamine) 400 mg delayed-release tablets dosed three times daily (2.4 grams).

The European and U.S. clinical trials are powered to show a statistical difference between budesonide MMX and placebo. The reference arms using Entocort EC in the European trial and Asacol in the U.S. trial are not powered to show statistical differences versus budesonide MMX.

Additionally, up to approximately 150 patients are expected to continue in a 12-month double-blind extended use trial to evaluate the long term safety and tolerability of budesonide MMX 6 mg and to collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo. The U.S. Food and Drug Administration (FDA) requested that the results of the 12-month extended use trial be included in the Phase III clinical program to support a U.S. regulatory submission.

The protocols for the budesonide MMX Phase III clinical program were reviewed and approved by the FDA under Special Protocol Assessments.

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