FDA Approves Uceris for Ulcerative Colitis

Joe Barber Jr, PhD

January 18, 2013

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.

"We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis," Gerald T. Proehl, president and chief executive officer, Santarus, commented in a news release.

Bryan L. Love, PharmD, BCPS, agreed that the approval of the drug provides clinicians with another viable treatment modality. "The approval of Uceris gives patients and clinicians a new therapeutic option for the induction of remission in active ulcerative colitis," Dr. Love told Medscape Medical News by email.

"The MMX multimatrix delivery system is a unique feature of Uceris that allows for continuous release of budesonide throughout the entire colon," he continued. "This delivery system avoids releasing the medication too quickly as the tablet travels through the colon, maximizing the concentrations available to affected areas within the colon."

Moreover, Dr. Love noted that this drug is associated with less toxicity than other treatment options. "Budesonide is a potent corticosteroid with minimal systemic activity due to rapid inactivation in the liver," Dr. Love said. "In essence, Uceris provides the benefit of a potent anti-inflammatory drug delivered locally to the colon mucosa without many of the troublesome systemic side effects associated with systemic corticosteroids."

Dr. Love has disclosed no relevant financial relationships.