FDA News

FDA grants tentative approval for Uceris for ulcerative colitis

The FDA has granted tentative approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis, according to a company press release.

Budesonide (Uceris, Salix Pharmaceuticals) 2 mg corticosteroid, applied rectally, enables better distribution of active drug to the distal colon unlike currently approved and often ineffective therapies, the release said.

“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,” Bill Forbes, executive vice president, medical and research and development and chief development officer of Salix, said in the release. “People suffering from distal UC [ulcerative colitis] now have another option to consider when facing this disease.”

The approval follows two phase 3 studies that found “a significantly greater percentage of patients receiving Uceris 2 mg rectal foam achieved remission of distal ulcerative colitis at 6 weeks compared with placebo (41.2% vs. 24%).” In addition, patients treated with budesonide had improvements in disease activity and rectal bleeding.

William J. Sandborn

“These trials 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,” trial researcher William J. Sandborn, MD, chief of the division of gastroenterology, director of the IBD Center at University of California, San Diego, said in the release. “Treatment with Uceris rectal foam also led to a rapid response for rectal bleeding that was sustained through the sixth week of the trial. Uceris rectal foam is a welcome addition to the treatment options available to gastroenterologists and their patients coping with this complex disease.”

The tentative approval from the FDA indicates that the product meets standards of manufacturing, quality, safety and efficacy and will receive final approval upon resolution of patent issues before the end of the year. The product is expected to launch in early 2015.

The FDA has granted tentative approval for budesonide rectal foam for the induction of remission in patients with mild to moderately active distal ulcerative colitis, according to a company press release.

Budesonide (Uceris, Salix Pharmaceuticals) 2 mg corticosteroid, applied rectally, enables better distribution of active drug to the distal colon unlike currently approved and often ineffective therapies, the release said.

“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,” Bill Forbes, executive vice president, medical and research and development and chief development officer of Salix, said in the release. “People suffering from distal UC [ulcerative colitis] now have another option to consider when facing this disease.”

The approval follows two phase 3 studies that found “a significantly greater percentage of patients receiving Uceris 2 mg rectal foam achieved remission of distal ulcerative colitis at 6 weeks compared with placebo (41.2% vs. 24%).” In addition, patients treated with budesonide had improvements in disease activity and rectal bleeding.

William J. Sandborn

“These trials 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,” trial researcher William J. Sandborn, MD, chief of the division of gastroenterology, director of the IBD Center at University of California, San Diego, said in the release. “Treatment with Uceris rectal foam also led to a rapid response for rectal bleeding that was sustained through the sixth week of the trial. Uceris rectal foam is a welcome addition to the treatment options available to gastroenterologists and their patients coping with this complex disease.”

The tentative approval from the FDA indicates that the product meets standards of manufacturing, quality, safety and efficacy and will receive final approval upon resolution of patent issues before the end of the year. The product is expected to launch in early 2015.

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