Salix Pharmaceuticals Announces the Publication of a Study Evaluating the Safety and Efficacy of UCERIS® (budesonide) Tablets for Induction of Remission in Patients with Active Mild to Moderate Ulcerative Colitis Refractory to Mesalamine Therapy

BRIDGEWATER, N.J., May 18, 2017 /PRNewswire/ -- Salix Pharmaceuticals today announced the peer-reviewed publication of a study in the Journal of Crohn's & Colitis evaluating the safety and efficacy of budesonide multimatrix (MMX), which was examined for induction of remission in patients with mild to moderate ulcerative colitis (UC) refractory to baseline mesalamine therapy. Budesonide MMX or UCERIS tablets, is a prescription corticosteroid medicine used to help get mild to moderate UC under control.

The study evaluated budesonide MMX 9 mg administered once daily for eight weeks for the induction of remission of mild to moderate UC not adequately controlled by stable, oral mesalamine therapy. The results of this randomized, double-blind, placebo-controlled study evaluated the efficacy, safety, and tolerability of once-daily, oral budesonide MMX 9 mg for the induction of remission of patients with mild to moderate UC unresponsive to oral mesalamine monotherapy.

Lead author David T. Rubin, M.D., Professor and Chief of Gastroenterology at The University of Chicago Medicine explained, "The data suggest the efficacy and safety of UCERIS in patients experiencing an active flare of UC despite initial oral 5-ASA therapy."

This multicentre, randomized, double-blind, placebo-controlled study was conducted in the USA, Canada, and Europe. Patients aged 18 to 75 years with active mild to moderate UC were included. Patients were randomized 1:1 to receive budesonide MMX 9 mg or placebo once daily after breakfast for eight weeks in an outpatient setting.  The study consisted of a two-week screening phase, an eight-week treatment phase, and a four-week posttreatment phase. Additional details on the study methodology can be found by clicking here.

About UCERIS^® 

UCERIS^® (budesonide) extended release tablets are a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

UCERIS extended release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS tablets. Anaphylactic reactions have occurred with other budesonide formulations.

When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.

Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients. Taper patients slowly from systemic corticosteroids if transferring to UCERIS tablets.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients.

Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.

In clinical studies, the most common adverse reactions of UCERIS tablets (occurring in ≥2% of UCERIS patients and at a higher incidence than placebo) were headache (11%), nausea (5%), decreased blood cortisol (4%), upper abdominal pain (4%), fatigue (3%), flatulence (2%), abdominal distension (2%), acne (2%), urinary tract infection (2%), arthralgia (2%), and constipation (2%).

Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Advise patients to avoid ingestion of grapefruit and grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS tablets.

Since the dissolution of the coating of UCERIS tablets is pH dependent, the release properties and uptake of the compound may be altered when UCERIS tablets are used after treatment with gastric acid–reducing agents (eg, PPIs, H2-blockers and antacids).

There are no adequate and well-controlled studies in pregnant women. Budesonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue UCERIS tablets, taking into account the clinical importance of UCERIS tablets to the mother.

Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS tablets should be considered in these patients.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Please click here for full Prescribing Information for UCERIS Tablets.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center
Phone: 1-800-321-4576
Fax: 1-510-595-8183
Email: [email protected]

About Ulcerative Colitis

Ulcerative colitis is a form of chronic inflammatory bowel disease that produces inflammation and ulcers along the inside of the colon, which can interfere with the normal function of the colon. The disease typically starts to manifest in patients as young adults. Ulcerative colitis is an intermittent disease with periods of exacerbated symptoms, or flares, and periods that are relatively symptom-free. Although the symptoms of ulcerative colitis may resolve without treatment, the disease usually requires medication to go into remission. According to the Crohn's and Colitis Foundation of America, as many as 700,000 people in the U.S. suffer from ulcerative colitis.

About Salix

Salix Pharmaceuticals, Ltd., a Valeant Pharmaceuticals International, Inc. company, is one of the largest gastrointestinal specialty pharmaceuticals companies in the world. Salix develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases and disorders. For more information on Salix Pharmaceuticals, visit www.salix.com.

Forward-looking Statements

This press release contains forward-looking statements.  Forward-looking statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Readers are cautioned not to place undue reliance on any of these forward-looking statements.  These forward-looking statements speak only as of the date hereof. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, unless required by law.

UCE.0042.USA.17

Contact Information:
Salix Pharmaceuticals
Karen Paff, (347) 920-0248
[email protected]

SOURCE Salix Pharmaceuticals, Ltd.