First sulfite-free rectal suspension for UC

Jan 13 2010

sfRowasa™ (mesalamine) Rectal Suspension 4g/60mL –Sulfite-Free Formulation, is the first sulfite-free rectal suspension available for Ulcerative colitis (UC). According to a study published in The American Journal of Gastroenterology, products containing sulfites may exacerbate natural sulfide levels in the colon and may increase inflammation in UC patients. With its sulfite-free preparation, sfRowasa™ offers a new treatment option for the treatment of active, mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

“UC is a chronic, inflammatory bowel disease (IBD) affecting approximately one half million people in the United States. This chronic disorder is interspersed with episodes of acute worsening (flares) that are characterized by rectal bleeding and abdominal pain”

According to the U.S. Food and Drug Administration (FDA), sulfites are a group of sulfur-based compounds that occur naturally or may be added to food as an enhancer and preservative. Potassium metabisulfite is a preservative currently used in all mesalamine rectal suspension products, except for sfRowasa™. It is believed that potassium metabisulfite converts to hydrogen sulfide and sulfuric acid when introduced in the colon (due to presence of water, oxygen, and/or sulfur reducing bacteria). According to an article published in The American Journal of Clinical Nutrition, hydrogen sulfide is toxic to colonocyte (colonic mucosal), which is implicated in UC.

“UC is a chronic, inflammatory bowel disease (IBD) affecting approximately one half million people in the United States. This chronic disorder is interspersed with episodes of acute worsening (flares) that are characterized by rectal bleeding and abdominal pain” said Stephen B. Hanauer, MD Professor of Medicine and Clinical Pharmacology, University of Chicago Medical Center. He added,“Rectal mesalamine therapy is recommended as the primary choice in controlling acute flares quickly in patients with disease of the distal colon. sfRowasa may improve tolerability in certain patients who are intolerant to sulfites and the potential benefits of this treatment option would be a useful and welcome addition to the current therapeutic choices for these debilitating acute flares.”