FDA accepts Salix’s NDA filing for Budesonide foam in patients with distal ulcerative colitis

The FDA has issued an action date of 15 September 2014 under the Prescription Drug User Fee Act (PDUFA).

Budesonide is a high potency corticosteroid developed to reduce the systemic adverse consequences of classic corticosteroids, such as hydrocortisone, which have higher levels of systemic absorption.

The company said that in several large studies budesonide 2 mg rectal foam was highly effective in the treatment of distal ulcerative colitis.

According to the clinical trials, budesonide foam formulation shows 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.

The trials also show that the foam provides more immediate and targeted therapy for distal ulcerative colitis than is available with oral therapies.

Salix executive vice president of Medical and Research and Development and chief development officer Bill Forbes said 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," Forbes said.

"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."