Salix announced that the Food and Drug Administration (FDA) has granted tentative approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.

Two randomized, double-blind, placebo-controlled Phase 3 studies (n=546) found that a significantly greater percentage of patients treated with Uceris 2mg rectal foam achieved remission of distal ulcerative colitis at 6 weeks vs. placebo (41.2% vs. 24.0%). Also, patients treated with Uceris rectal foam also achieved key secondary outcome measures compared with placebo at six weeks, including a Modified Mayo Disease Activity Index (MMDAI) endoscopy score of 0 or 1.

RELATED: Ulcerative Colitis Treatments

Uceris, a glucocorticosteroid, is currently available as 9mg extended-release tablets indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis.

The FDA’s tentative approval indicates that upon resolution of patent issues, Uceris rectal foam will be granted final approval. The launch of Uceris rectal foam is anticipated for the first quarter of 2015.

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