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 demo
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