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Publication Number
US-12064509-B2
Publication Date
2024-08-20
Expiration Date
Abstract
Provided is an enema for rectal application containing budesonide as an active ingredient in order to treat inflammatory bowel disease, or to prevent a relapse. The enema for rectal application containing budesonide as the active ingredient, in which 1.5 to 2.5 mg of budesonide per dose is administered twice a day for 6 weeks in order to treat inflammatory bowel disease, or to prevent a relapse; the enema for rectal application described above, in which a dose of budesonide is 2.0 mg per dose; the enema for rectal application according to any one of the above, which is taken in order to treat ulcerative colitis or Crohn's disease, or to prevent a relapse; the enema for rectal application according to any one of the above, which has a foamy shape or a liquid shape.
Core Innovation
The disclosed invention relates to an enema for rectal application that contains budesonide and is transanally administered to a subject. The enema contains budesonide in an amount of 1.5 to 2.5 mg per dose, administered twice a day for 6 weeks, with an interval at least 6 hours between the first and second administrations in the twice-daily schedule.
The stated uses include treating inflammatory bowel disease or preventing relapse of inflammatory bowel disease, and healing intestinal mucosa caused by inflammatory bowel disease. The inflammatory bowel disease is described as ulcerative colitis or Crohn’s disease, and the disclosure encompasses either a foamy shape or a liquid shape for the enema formulation while maintaining the budesonide twice-a-day regimen for 6 weeks.
The disclosed results include a randomized double-blind placebo-controlled study comparing budesonide 2 mg once daily versus twice daily for 6 weeks. The twice-daily regimen is asserted to provide higher remission, mucosal remission, and mucosal healing rates, with acceptable safety and tolerability.
Claims Coverage
The independent claims cover three principal inventive outcomes using a shared core dosing regimen of a transanally administered budesonide enema.
Budesonide enema twice daily for 6 weeks
A method of treating inflammatory bowel disease or preventing relapse by transanally administering an enema comprising 1.5 to 2.5 mg of budesonide twice a day for 6 weeks.
Treatment of inflammatory bowel disease by intestinal mucosa healing
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 6 weeks.
Across the independent claims, the inventive concept is a transanally administered budesonide enema given at 1.5 to 2.5 mg twice a day for 6 weeks, directed to treating inflammatory bowel disease, preventing relapse, and healing intestinal mucosa.
Stated Advantages
Superior mucosal curing versus once-daily regimens, with higher remission, mucosal remission, and mucosal healing rates.
Acceptable safety and tolerability.
Documented Applications
Treating inflammatory bowel disease in a subject, including ulcerative colitis or Crohn’s disease, by transanal administration of a budesonide enema.
Preventing relapse of inflammatory bowel disease in a subject by transanal administration of a budesonide enema.
Healing intestinal mucosa caused by inflammatory bowel disease by transanal administration of a budesonide enema.
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