A novel formulation of Multi-Matrix SystemTM (MMX) mesalamine (MesavanceTM) induces remission in patients with active mild-to- moderate ulcerative colitis and is generally well-tolerated at once-daily and twice-daily dosing, researchers announced at the here at Digestive Disease Week (DDW).

The new findings, from two pivotal phase III trials, showed that MMX mesalamine was effective in patients switched from other oral 5-ASA therapies and in patients who were 5-ASA-naive. MMX mesalamine at both doses tested induced remission in patients with left-sided or extensive disease, with no correlation between disease location and treatment activity.

Principal investigator William J. Sandborn, MD, professor of medicine at the Mayo Clinic in Rochester, Minnesota, presented the combined results of Studies 301 and 302, which assessed the efficacy and tolerability of MMX mesalamine in once-daily and twice-daily dosing.

The data were combined for the 172 patients randomized to MMX mesalamine 2.4 g/day (given once daily in Study 302 or twice daily in Study 301), 174 patients assigned to MMX mesalamine 4.8 g/day (given once daily in studies 301 and 302), and 171 placebo-treated patients.

At week 8, significantly more patients achieved remission in the MMX mesalamine 2.4 g/day group compared with the placebo group (37.2% vs. 17.5% [P

“These data show that this novel formulation of MMX mesalamine was generally well tolerated and induced remission in patients with active mild-to-moderate ulcerative colitis,” Dr. Sandborn said.

“The current standard of care for the induction and maintenance of remission in ulcerative colitis is mesalamine,” added Michael A. Kamm, MD, a study co-author and professor of gastroenterology at St. Mark’s Hospital in London, UK. “However, presently available oral formulations do not consistently deliver the active drug to the entire colon and require inconvenient, multiple daily dosing regimens which may reduce patient compliance and efficacy and adversely affect overall treatment outcomes. Mesalamine MMX provides delayed and extended delivery of the active drug to the entire colon, thereby creating the potential for once-daily administration.”

Mesalamine is used as a first-line treatment for mild-to-moderate ulcerative colitis. MMX mesalamine utilizes a novel proprietary MMX technology to provide the highest mesalamine dose per tablet (1.2 g). It also employs a gastro-resistant polymer to delay release of the active drug until it reaches the terminal ileum, and the MMX drug delivery technology is believed to extend delivery of 5-ASA consistently throughout the entire colon.

The medication is currently under review by the FDA and regulatory agencies in Canada and the European Union.

By Jill Stein
Jill Stein is a Paris-based freelance medical writer
Jillstein03@cs.com