A proposed treatment for a difficult to threat form of rectal inflammation from Salix Pharmaceuticals is moving closer to approval by the FDA.
Salix (NASDAQ: SLXP) said early Thursday that the FDA has accepted a New Drug Application. Action is expected by Sept. 16.
In May, Salix said 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.
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.
“Patients with distal ulcerative colitis, also known as proctitis or proctosigmoiditis, are often difficult to treat and present the most challenging subset of patients given the limitations of available treatment options,” said Bill Forbes, chief development officer and executive vice president for medical research and development at Salix. “For these patients with disease limited to the rectum and sigmoid areas of the colon, treatment with currently approved oral therapies is often ineffective due to insufficient distribution of active drug to the distal colon. Distal ulcerative colitis remains an unmet medical need, and we believe the availability of a rectally administered corticosteroid such as budesonide foam may help overcome limitations of existing products to treat this condition.”
