Salix’s UCERIS Granted Tentative FDA Approval for Distal Ulcerative Colitis

Salix’s UCERIS Granted Tentative FDA Approval for Distal Ulcerative Colitis
Salix's UCERISSalix Pharmaceuticals may soon bring a new treatment for mild-to-moderate distal ulcerative colitis to the market with its tentative Food and Drug Administration (FDA) approval for UCERIS (budesonide) rectal foam. The product, which is a rectally-administered corticosteroid foam, addresses limitations of other currently approved therapies. "The unique delivery system of UCERIS rectal foam can help overcome current treatment limitations by reaching the affected area of the distal colon and keeping the medication there long enough to be effective," said Bill Forbes, Executive Vice President of Medical and Research Development and Chief Development Officer of Salix, in a news release from the company. "People suffering from distal ulcerative colitis now have another option to consider when facing this disease." In fact, rectal therapy is the recommended means for inducing remission in patients with mild-to-moderate ulcerative proctitis and patients with mild-to-moderate ulcerative colitis. Enemas and suppositories used today can be difficult to administer and provide a small spread of distribution to afflicted areas of the colon. Although UCERIS was not tested head-to-head against these other treatments, it was evaluated through a number of preclinical studies and clinical trials.
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