Uceris, Treatment for Ulcerative Colitis Approved by the FDA
Posted Jan 19 2013 10:11pm
This is a new option for treatment and is a once a day single pill dose. The drug has less toxicity that other treatments according to one physician and may offer fewer side effects versus using a steroid type treatment. The drug is to treat mild to moderate ulcerative colitis in adults. BD
From the website: UCERIS is an investigational product that is a corticosteroid in a novel oral tablet formulation that uses proprietary MMX® colonic delivery technology designed to result in the controlled release and distribution of budesonide throughout the length of the colon. A New Drug Application for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild-to-moderate active ulcerative colitis is under review by the U.S. Food and Drug Administration with a target action date in January 2013. Ulcerative colitis is a form of inflammatory bowel disease that produces ulcerations along the lining of the colon and rectum.
The US Food and Drug Administration (FDA) has approved budesonide extended release tablets (Uceris, Santarus) for the treatment of active mild to moderate ulcerative colitis in adult patients, the manufacturer announced January 16.
The therapy contains the corticosteroid budesonide in an oral formulation that employs the proprietary MMX multimatrix system colonic delivery technology. The approved dosing regimen for the drug, which was developed in collaboration with Cosmo Technologies Limited, is a single 9-mg tablet taken once daily in the morning for up to 8 weeks.