Budesonide MMX meets Phase III endpoint

Santarus Inc. (NASDAQ:SNTS) and Cosmo Pharmaceuticals S.p.A. (SIX:COPN) said the higher of two doses of budesonide MMX met the primary endpoint of superiority to placebo in the proportion of patients with ulcerative colitis who achieved clinical remission at week eight in the Phase III CB-01-02/01 trial (17.9% vs. 7.4%, p=0.0143). The lower dose 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 Asacol mesalamine from Warner Chilcott plc (NASDAQ:WCRX) showed a 12.1% remission rate, though the partners said the study was not powered to show a statistical difference between the Asacol and budesonide MMX treatment arms. Santarus has an SPA from FDA for the double-blind, U.S. and Indian trial, which enrolled 489 patients. Budesonide MMX is budesonide delivered using MMX multi-matrix system technology. ...