Budesonide MMX: Phase III data
Top-line data from the double-blind, U.S. and Indian Phase III CB-01-02/01 trial in 489 patients showed that once-daily 9 mg budesonide MMX met the primary endpoint of superiority to placebo in the proportion of patients achieving clinical remission as measured by UCDAI score at week 8 (17.9% vs. 7.4%, p=0.0143). The once-daily 6 mg dose of budesonide MMX missed the endpoint (13.2%, p=0.1393). According to the trial's protocol, the budesonide MMX treatment arms each required a p-value of 0.025 compared with placebo to achieve statistical significance.
A reference arm evaluating 2.4 g/day Asacol mesalamine from Warner Chilcott plc (NASDAQ:WCRX, Ardee, Ireland) showed that 12.1% of patients achieved remission, though the partners said the trial was not powered to show a statistical difference between the Asacol and budesonide MMX treatment arms. Both doses of budesonide MMX were well tolerated, and the frequency of adverse events was similar to placebo. Santarus has an SPA from FDA for the trial. ...