FDA Accepts NDA for Budesonide Rectal Foam
Salix announced that the FDA has accepted for filing a New Drug Application (NDA) for Budesonide 2mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40cm from the anal verge.
In several large studies budesonide 2mg rectal foam was found to be effective in the treatment of distal ulcerative colitis. Clinical trials suggest that budesonide foam demonstrates improved reach and rapid distribution of budesonide to the sigmoid colon and the rectum compared to enema formulations. These trials also suggest that the foam provides immediate and targeted therapy for distal ulcerative colitis.
The oral foam formulation for rectal administration was designed to improve both the patient's ability to retain the drug in the rectum following administration as well as distribution of the active drug to the rectum and sigmoid colon.
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