Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11464733-B2
Publication Date
2022-10-11
Expiration Date
Abstract
Provided is an enema for rectal application containing budesonide as an active ingredient in order to treat an inflammatory bowel disease, or to prevent a relapse.The enema for rectal application contains budesonide as the active ingredient, in which 1.5 to 2.5 mg of budesonide per dose is administered twice a day for 12 weeks in order to treat an inflammatory bowel disease, or to prevent a relapse. The enema for rectal application comprises several doses whereby the most preferable dose of budesonide is 2.0 mg per dose. The enema for rectal application is taken in order to treat ulcerative colitis or Crohn's disease, or to prevent a relapse; has a foamy, more rigid to a more liquid, gel-like structure.
Core Innovation
The invention provides a method of preventing relapse of inflammatory bowel disease by transanally administering an enema comprising budesonide. The enema contains 1.5 to 2.5 mg of budesonide administered twice a day for 12 weeks, where each twice-daily administration is performed after an interval of 6 hours or more. The document further describes budesonide rectal enema formulations having a foamy or gel-like structure and relating the approach to mucosal healing and relapse prevention.
A second aspect is a method of healing intestinal mucosa caused by inflammatory bowel disease using a transanal budesonide enema. The treatment specifies 1.5 to 2.5 mg budesonide twice a day for 12 weeks, with twice-daily administrations separated by an interval of 6 hours or more. The described evaluation includes endoscopic assessment and an emphasis on healing of the intestinal mucosa.
The background problem described in the provided content concerns inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, where relapse and incomplete mucosal healing are clinically relevant. The document provides clinical evidence from a placebo-controlled randomized double-blind multicenter trial using a budesonide 2 mg rectal foam aerosol administered twice daily, with continuation to 12 weeks in non-complete mucosal healers, and reports substantially higher proportions of endoscopic view score 0 at week 12 versus placebo. The document also reports no deaths and no severe/serious adverse events, and describes cortisol/ACTH parameters largely normalizing after treatment cessation.
Claims Coverage
The provided material includes two independent claims that share the same core regimen: transanal budesonide enema dosing of 1.5 to 2.5 mg twice daily for 12 weeks, with a timing constraint of an interval of 6 hours or more between twice-daily administrations. The claims differ by the intended therapeutic effect: preventing relapse versus healing intestinal mucosa.
Preventing relapse of inflammatory bowel disease by a transanal budesonide enema regimen
A method of preventing relapse of inflammatory bowel disease by transanally administering an enema comprising 1.5 to 2.5 mg of budesonide twice a day for 12 weeks, wherein when administering twice a day, the enema is administered twice after an interval of 6 hours or more.
Healing intestinal mucosa caused by inflammatory bowel disease by a transanal budesonide enema regimen
A method of healing intestinal mucosa caused by inflammatory bowel disease by transanally administering an enema comprising 1.5 to 2.5 mg of budesonide twice a day for 12 weeks, wherein when administering twice a day, the enema is administered twice after an interval of 6 hours or more.
Across the independent claims, the inventive coverage centers on transanal administration of a budesonide enema with 1.5 to 2.5 mg twice daily over 12 weeks, with twice-daily administrations separated by an interval of 6 hours or more, for either preventing relapse or healing intestinal mucosa.
Stated Advantages
Higher proportion of endoscopic view score 0 at week 12 versus placebo (40% vs 0%) in the budesonide group.
No deaths were reported and no severe/serious adverse events were reported.
Cortisol/ACTH parameters were largely normalizing after treatment cessation.
Documented Applications
Preventing relapse of inflammatory bowel disease by transanally administering a budesonide enema in an ulcerative colitis or Crohn’s disease context.
Healing intestinal mucosa caused by inflammatory bowel disease via transanal administration of a budesonide enema for a 12-week treatment period, including evaluation by endoscopic finding score.
Interested in licensing this patent?