FDA Grants Salix’s UCERIS Rectal Foam for Ulcerative Colitis Final Approval

FDA Grants Salix’s UCERIS Rectal Foam for Ulcerative Colitis Final Approval

salixThe U.S. Food and Drug Administration (FDA) recently approved UCERIS (budesonide) rectal foam, developed by Salix Pharmaceuticals, to induce remission in patients suffering from active mild-to-moderate distal ulcerative colitis (UC) extended up to 40 cm from the anal verge. The therapy works through the use of corticosteroid foam, which is rectally administered, and it is indicated for use alone or combined with oral aminosalicyclic acid (ASA).

There are other available rectal therapies, however, Salix Pharmaceuticals believes that the UCERIS is able to overcome the limitations that other therapies include, such as difficulty of administration and retention (enemas), and limited proximal spread (suppositories). The foam is meant to minimize the systemic adverse effects of other classic corticosteroids, like hydrocortisone, as well as enhance patients’ capacity to retain the medication in the rectum after the administration.

The clinical trials conducted by Salix revealed UCERIS rectal foam’s efficacy to distribute rapidly budesonide to the sigmoid colon and rectum, without the difficulties and inconvenience related to retention of enema formulations, in the treatment of distal ulcerative colitis. In addition, the research also demonstrated that the foam is also able to offer therapy in a more immediate and targeted way than other oral treatments available.

The FDA had already granted UCERIS tentative approval last September, pending expiration of the 45-day waiting period according to the Federal Food, Drug and Cosmetic Act. The product had already been approved in Europe in 2006 and is marketed by Dr. Falk Pharma.

Ulcerative colitis, one of the most common and severe inflammatory bowel diseases, is chronic and causes abdominal discomfort and frequent emptying of the colon, affecting about 700,000 Americans, according to the Crohn’s and Colitis Foundation of America (CCFA). The foundation also estimates that 46% of the patients are also diagnosed with distal UC, experiencing mild symptoms, which includes persistent diarrhea, abdominal pain and blood in the stool.

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