Salix planning NDA submission for budesonide for UC

Salix Pharmaceuticals Inc. (NASDAQ:SLXP) said budesonide rectal foam given twice daily for two weeks and then once daily for four weeks met the primary endpoint in a pair of Phase III trials to treat ulcerative colitis (UC). Budesonide rectal foam led to a greater proportion of patients achieving remission at the end of six weeks of treatment or withdrawal vs. placebo foam. The identical trials enrolled patients with active mild to moderate ulcerative proctitis or ulcerative proctosigmoiditis.

Salix plans to submit by the end of September an NDA to FDA for budesonide rectal foam to treat ulcerative proctitis, UC limited to the rectum, and ulcerative proctosigmoiditis, UC in the rectum and sigmoid colon. Dr. Falk Pharma GmbH (Freiburg, Germany) markets the product -- a foam formulation of budesonide, a glucocorticosteroid -- for the indications in Europe. Salix has exclusive rights from Dr. Falk to develop and commercialize budesonide products in the U.S. ...