Generic Version Uceris Rectal Foam Now Available

A generic version of Uceris^® (budesonide 2mg rectal foam) has been made available by Padagis.

Budesonide 2mg Rectal Foam is a glucocorticoid indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40cm from the anal verge. The treatment is supplied in a kit containing 2 aerosol canisters each containing 14 metered doses (2mg of budesonide per metered dose).

The safety and efficacy of budesonide rectal foam was evaluated in 2 double-blind, placebo-controlled studies. In both trials, a higher proportion of patients treated with budesonide rectal foam were in remission (primary endpoint) and had a rectal bleeding subscore of 0 at week 6, compared with placebo. The most common adverse reactions reported with budesonide rectal foam were decreased blood cortisol, adrenal insufficiency, and nausea.

Padagis was granted 180 days of Competitive Generic Therapy exclusivity for Budesonide Rectal Foam by the Food and Drug Administration.