Uceris Approved for Active Ulcerative Colitis #UC #IBD

Uceris sounds just like a drug that has been around for a while, Entercort (spelling?).  It works the same exact way Uceris works; it's a form of a steroid and releases in the colon.  Wonder what the difference is?/

January 15, 2013

Uceris Approved for Active Ulcerative Colitis

Santarus announced that the FDA has approved Uceris (budesonide) extended-release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Uceris contains budesonide in a novel oral tablet formulation that utilizes proprietary MMX multi-matrix system technology, which is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide is a corticosteroid known to have localized anti-inflammatory effect.

Uceris will be available in 9mg extended-release tablets in 30-count bottles. Uceris is expected be available in March 2013.

For more information call (858) 314-5700 or visit www.santarus.com

Uceris Approved for Active Ulcerative Colitis - MPR:


http://www.drugs.com/newdrugs/santarus-receives-fda-approval-uceris-budesonide-induction-remission-patients-active-mild-moderate-3638.html

FDA Approves Uceris

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

SAN DIEGO--(BUSINESS WIRE)--Jan 15, 2013 - Santarus, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Uceris (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. The company expects to commence the commercial launch of Uceris in March 2013.

“The FDA approval of Uceris provides an important new therapeutic option to patients and physicians for the treatment of active, mild to moderate ulcerative colitis,” said William J. Sandborn, M.D., chief, division of Gastroenterology, director, University of California San Diego (UCSD) IBD Center and professor of clinical medicine, UCSD Health System. “Specifically, Uceris is indicated for use in the induction of remission of active disease, an acute phase of the disease often characterized by cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements.”Uceris contains budesonide, a corticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX^® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. Uceris was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A.

Gerald T. Proehl, president and CEO of Santarus, said, “We are pleased to provide a new option for patients to treat the active phase of mild to moderate ulcerative colitis. With the incremental revenue from Uceris and continued growth in our marketed products, we anticipate another robust year of solid financial results for Santarus in 2013. We expect total revenues of $320 million to $325 million, representing significant double-digit growth over our 2012 revenue guidance."

Important Safety Information About Uceris

Uceris is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. Uceris is taken once daily in the morning with or without food for up to 8 weeks.

• Do not take Uceris if you are allergic to budesonide or any of the ingredients in Uceris.
• Before you take Uceris, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
• Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. Uceris and other medicines may affect each other, causing side effects.
• Do not eat grapefruit or drink grapefruit juice while taking Uceris because these can increase the level of Uceris in your blood.
• Long-time use of Uceris can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
• When Uceris is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with Uceris, including tiredness, weakness, nausea and vomiting, and low blood pressure.
• Uceris weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking Uceris. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
• If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to Uceris may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking Uceris.
• The most common side effects with Uceris are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.

Uceris is available by prescription only. For additional information, talk to your healthcare provider and see the Full Prescribing Information including Patient Labeling.