Ferring Pharmaceuticals’ CORTIMENT (budesonide), a treatment for ulcerative colitis indicated for the induction of remission in patients who have an active, mild to moderate form of the disease, recently received marketing approval by the European Union through the EU’s Mutual Recognition Procedure. The drug was already available in the Netherlands since 2013, and the company now plans on launching it in 27 other European countries within the next few months.
CORTIMENT is a novel oral tablet formulation that contains the locally acting glucocorticosteroid budesonide, and uses the company’s multi matrix colonic delivery technology. The drug is prescribed to be administered as a 9 mg tablet daily for up to eight weeks in adults. A phase III study revealed that between 2.4 to 3.9 times more patients were able to achieve clinical and endoscopic remission with CORTIMENT, in comparison to placebo. In addition, no clinically significant side effects were registered.
“Well over two million people in Europe suffer from ulcerative colitis,” noted Simon Travis, the consultant gastroenterologist at Oxford University and the John Radcliffe Hospital, UK. “CORTIMENT, with its proven efficacy and safety profile, will provide an important new option for physicians treating active, mild to moderate ulcerative colitis.”
“Bringing relief to sufferers of inflammatory bowel disease (IBD) is a key area of focus for Ferring, as evidenced by our PENTASA® (mesalazine) range of IBD treatments,” said Michel Pettigrew, the president of the Executive Board and COO of Ferring. “With the launch of CORTIMENT, a new treatment with a novel formulation for active mild to moderate ulcerative colitis, we will expand our portfolio and build on our commitment to innovation in gastroenterology.”
Ferring Pharmaceuticals is currently commercializing CORTIMENT, which was developed by Cosmo Pharmaceuticals SpA, in the EU, Asia Pac with the exception of Japan, Australia, Canada, Latin America and Africa. The drug is also available in the United States under the name UCERIS, and is commercialized by Salix Pharmaceuticals, Inc.
The U.S. Food and Drug Administration recently approved UCERIS (budesonide) rectal foam, a month after granting the treatment tentative approval.