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FDA Agrees to Review Budesonide Foam for Patients With Ulcerative Colitis

Approval decision slated for September 2014 (January 30)

The FDA has accepted for filing a new drug application (NDA) 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 agency has issued an action date of September 15, 2014 under the Prescription Drug User Fee Act (PDUFA).

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

Budesonide 2 mg rectal foam was effective in treating distal ulcerative colitis in several large studies. According to the product’s developer (Salix Pharmaceuticals), clinical data suggest that the budesonide foam formulation offers improved reach (or spread) and rapid distribution of budesonide to the sigmoid colon and the rectum, without the difficulties and inconvenience associated with the 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 foam formulation for rectal administration was designed to improve both the patient’s ability to retain the drug in the rectum following administration and the distribution of the active drug to the rectum and sigmoid colon.

Source: Salix Pharmaceuticals; January 30, 2014.

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