FDA approves budesonide for the induction of remission in patients with active, mild to moderate ulcerative colitis

January 17, 2013

FDA has approved budesonide (Uceris, Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals SpA) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

 

FDA has approved budesonide (Uceris, Santarus and Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals SpA) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Ulcerative colitis is a form of chronic inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon, which can interfere with the normal function of the colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, as many as 700,000 people in the United States suffer from ulcerative colitis.

The drug is expected to be launched in March 2013.

Uceris contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX multimatrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks.

"The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis," William J. Sandborn, MD, chief, division of Gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System, said in a press release.