The US Food and Drug Administration (FDA) has accepted Salix Pharmaceuticals’ New Drug Application (NDA) filing for budesonide 2 mg rectal foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. The FDA has issued an action date of September 15, 2014 under the Prescription Drug User Fee Act (PDUFA).
Bill Forbes, executive vice president, Medical and Research and Development and chief development officer, Salix, stated, “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. 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.”
Budesonide is a high potency corticosteroid that was developed to minimize the systemic adverse consequences of classic corticosteroids, such as hydrocortisone, which have higher levels of systemic absorption. In several large studies budesonide 2 mg rectal foam was highly effective in the treatment of distal ulcerative colitis. Clinical trials suggest that the budesonide foam formulation demonstrates improved reach (or spread) and rapid distribution of budesonide to the sigmoid colon and the rectum, without the difficulties and inconvenience associated with retention of enema formulations. These trials also suggest that the foam provides more immediate and targeted therapy for distal ulcerative colitis than is available with oral therapies. 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. Salix licensed this budesonide foam product from Dr Falk Pharma. The product was approved in Europe in 2006 and is marketed in Europe by Dr Falk Pharma.
Salix Pharmaceuticals develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases.