Date: 2011-09-20
Type of information:
phase: 3
Announcement: results
Company: Cosmo Pharmaceutical (Italy) Santarus (USA)
Product: budesonide MMX®
Action mechanism: Budesonide MMX is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo’s proprietary MMX® multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.
Disease: induction of remission of mild or moderate active ulcerative colitis
Therapeutic area: Inflammatory diseases - Autoimmune diseases
Country: USA India Europe
Trial details: A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of budesonide MMX 6 mg. The extended use study evaluated patients with mild or moderate ulcerative colitis who had previously been enrolled in the Phase III clinical studies conducted by Santarus in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals S.p.A., at clinical sites in the U.S., India and Europe. The study was completed (last patient last visit) in late May 2011.
Latest
news: Cosmo Pharmaceuticals has announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide MMX® 6 mg or placebo will be provided as support for the planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the FDA for the induction of remission of mild or moderate active ulcerative colitis by its US partner Santarus. The submission is planned for December 2011. Cosmo and Santarus had previously announced results from two Phase III clinical studies that evaluated the safety and efficacy of budesonide MMX 9 mg over an eight week course of treatment for induction of remission of mild or moderate active ulcerative colitis.
A total of 123 patients were enrolled in the extended use study, which was undertaken to evaluate the long-term safety and tolerability of budesonide MMX 6 mg. Top-line results indicate:
* The frequency of treatment related adverse events for budesonide MMX 6 mg (21.0%) was similar to placebo (21.3%).
* Mean morning plasma Cortisol levels remained within normal limits at all visits for both budesonide MMX 6 mg and placebo.
* There were no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end-of-study between budesonide MMX 6 mg and placebo.
The extended use study also explored the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo, but the study was not powered to show statistical significance. The top-line efficacy analysis indicates that budesonide MMX 6 mg was not statistically different from placebo for the primary endpoint, which was the percentage of patients achieving clinical remission at 1, 3, 6, 9 and 12 months. However, there was a positive trend for the secondary endpoint of clinical relapse, which showed a higher percentage of placebo patients (59.4%) experienced clinical relapse vs. the budesonide MMX 6 mg group (30.8% ). Moreover, time to relapse (number of days without a new flare) was longer in the Budesonide group compared to placebo.
