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news.Salix Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) 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.
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The rectal foam is a rectally administered corticosteroid that overcomes treatment limitations related with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.
In September, the FDA tentatively approved UCERIS rectal foam pending expiration of the 45-day waiting period described in section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act.
Rectal therapy is recommended for the induction of remission in patients with ulcerative proctitis, and recommended alone or in combination with oral aminosalicyclic acid (ASA) for mild-to-moderate distal UC.
The company said that currently available rectal therapies have limitations, including difficulty of administration and retention and limited proximal spread.
The UCERIS rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam.