The Santarus’s extended-release budenoside tablets (Uceris) received the Food and Drug Administration (FDA) approval for the treatment of the active phase of mild to moderate form of ulcerative colitis. The drug was jointly developed by Santarus and Cosmo Technologies.
The tablets were formulated with a new drug delivery platform, multimatrix system (MMX) that releases budenoside extended-release molecules into the colonic mucosal tissues to decrease inflammation. The approved dose is 9 mg, once-daily tablet that should be taken in the morning time for a treatment period up to 8 weeks.
According to Gerald Proehl, President and CEO of Santarus, the company is delighted to present a new therapeutic option for the treatment of mild to moderate form of ulcerative colitis.
The USFDA’s approval of Uceris can pave a new, reliable treatment approach for the healthcare providers against ulcerative colitis, said Dr. Bryan Love, an independent reviewer. The new drug can promote remission in active phases of mild to moderate forms of ulcerative colitis, Dr. Bryan explained.
Uceris was developed by Santarus by an innovative drug development platform Multimatrix (MMX) delivery system to aid the continuous release of budenoside all over the colonic tissue. The sustained drug release can prevent rapid drug release and metabolic loss in the colon and hence increases the drug availability in the affected colon tissues, he said.
The reviewer said the Budenoside in MMX delivery system causes less adverse events than other treatments. Budenoside is rapidly metabolized in the liver, and it causes very less systemic events. Uceris, a corticosteroid can be a good anti-inflammatory drug that is delivered into the colonic mucosa by targeted delivery system without conventional adverse events, Dr. Bryan concluded.
Dr. Love discloses no financial interest with Santarus.