Salix Pharmaceuticals’ (NASDAQ:SLXP) experimental drug to treat inflammation in the colon and the rectum has completed late-stage clinical studies, readying the drug for an expected approval filing with the Food and Drug Administration.
Raleigh-based Salix said today its budesonide foam performed better than a placebo in two phase III clinical trials. The drug, a topical foam, is intended to treat mild to moderate ulcerative colitis (UC), an inflammatory disease affecting the colon lining, and ulcerative proctitis, which is ulcerative colitis that is limited to the rectum
The condition, which can cause symptoms including diarrhea, rectal bleeding and abdominal pain, is currently treated with oral treatments or enemas. Salix believes that its foam treatment will offer a better alternative. The company aims to file a new drug application with the FDA by the end of September.
Budesonide was developed by German company Dr. Falk Pharma, which has already commercialized the drug in Europe. Salix licensed budesonide from Dr. Falk in 2008 in a deal that could total up to $9.5 million, including milestone payments to Dr. Falk. If approved by the FDA, Salix would have to pay Dr. Falk royalties on net sales of budesonide. Budesonide’s U.S. patents expire in 2015.
