FDA Approves New Indication for the Treatment of Distal Ulcerative Colitis

Salix Pharmaceuticals announced today the US Food and Drug Administration (FDA) has extended final approval for Uceris (budesonide) rectal foam for the induction of remission in patients afflicted with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.

According to Salix, Uceris foam is “a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon.”

The FDA had granted tentative approval for Uceris on September 15, 2014, as the product had met all FDA manufacturing quality and clinical safety and efficacy standards. However, at the time there were several unresolved patent issues surrounding the medication. As those have now been resolved, Uceris has received final approval.

Uceris was first approved by the FDA in January 2013 in the form of extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

However, in the statement announcing Uceris had received tentative approval, Bill Forbes, Executive Vice President, Medical and Research and Development and Chief Development Officer, Salix, noted that distal ulcerative colitis can be challenging to treat. Now, “the unique delivery system of Uceris rectal foam can help overcome current treatment limitations by reaching the affected area of the distal colon and keeping the medication there long enough to be effective. People suffering from distal UC now have another option to consider when facing this disease.”

Approval for Uceris was based on data from two randomized, double-blind, placebo-controlled Phase III studies that enrolled a total of 546 patients with confirmed mild-to-moderate active distal UC extending ≥5cm, but no further than 40cm from the anal verge and Modified Mayo Disease Activity Index (MMDAI) endoscopy scores between 5 and 10. Patients were randomized 1:1 to receive UCERIS rectal foam (2 mg/25 mL; n=267) or placebo (n=279) twice daily for two weeks, then once daily for four weeks.

In the trials, a significantly greater percentage of patients treated with Uceris 2mg rectal foam achieved remission of distal ulcerative colitis at six weeks compared with placebo (41.2% vs 24.0%). Also, significantly more patients treated with UCERIS rectal foam also achieved key secondary outcome measures compared with placebo at six weeks, including a MMDAI endoscopy score of 0 or 1 in 55.6% versus 43.2% in the first trial and 56.0% vs 36.7% in the second trial.

A significantly greater percentage of patients treated with Uceris experienced improvement in rectal bleeding within the first two weeks of treatment.

William Sandborn, MD, Chief, Division of Gastroenterology and Director, UCSD IBD Center, University of California San Diego and UC San Diego Health System, and principle investigator of the trials, said these trial results “definitively demonstrated that UCERIS rectal foam is an efficacious and well-tolerated rectal therapy for the induction of remission in patients with mild-to-moderate distal UC. Treatment with UCERIS rectal foam also led to a rapid response for rectal bleeding that was sustained through the sixth week of the trial.”

“This unique treatment modality allows the medication to reach the target area and stay there long enough to work,” Sandborn said.

Uceris is contraindicated in patients with a known history of hypersensitivity to budesonide or any of its ingredients; reactions have included anaphylaxis. In the clinical trials, the most common adverse reactions (incidence ≥ 2%) were decreased blood cortisol, adrenal insufficiency, and nausea, according to the clinical studies.

Patients should be monitored if they are suffering from hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, have a family history of diabetes or glaucoma, or any other condition where glucocorticosteroids may have unwanted effects. Patients with moderate to severe hepatic impairment should carefully be observed for increased signs and/or symptoms of hypercorticism.