A rectal foam formulation of 2% budesonide has been approved by the Food and Drug Administration for treating distal ulcerative colitis, the manufacturer, Salix Pharmaceuticals, has announced.
The approved indication is for the induction of remission in patients with mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The foam is administered rectally and “overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon,” the company said in a statement announcing the final approval on Oct. 8.
The company will be marketing the product as Uceris.
The company also markets budesonide oral extended-release tablets under the same name.