Sigma-Tau Pharmaceuticals, Inc., a wholly owned subsidiary of the US based Sigma-Tau Group, has introduced VSL#3 JUNIOR, a once-a-day, high-potency probiotic medical food for the dietary management of children who suffer from irritable bowel syndrome (IBS) and ulcerative colitis (UC) in US markets.
Unlike other marketed probiotics, VSL#3 JUNIOR is presently the only probiotic sold as a medical food for IBS and UC. Refrigerated VSL#3 JUNIOR contains eight proprietary strains of 225 billion live bacteria, making it approximately 50 times more potent than the average probiotic.
IBS is a chronic disorder that interferes with the normal functions of the large intestine, resulting in symptoms such as cramping, abdominal pain, bloating, gas, and diarrhoea. Clinical research of VSL#3 JUNIOR in the dietary management of IBS and UC has yielded statistically significant results among patients for both designations, and is generally recognized as safe (GRAS). Moreover, it is the first probiotic medical food that has been studied in a paediatric, randomized, double-blind, placebo-controlled crossover trial for children. VSL#3 formulations have been clinically proven to provide a significant improvement in reducing the discomfort and bloating associated with IBS.
“We are very pleased to announce the commercial launch of VSL#3 JUNIOR, a key line extension of the VSL#3 brand and, more importantly, a powerful and unique new product to help the underserved paediatric patient population suffering from IBS and UC,” noted Dave Lemus, Chief Operating Officer of Sigma-Tau Pharmaceuticals. “Moreover, as the first probiotic medical food studied in a paediatric clinical trial environment, both physicians and parents can feel secure knowing that VSL#3 JUNIOR is safe and highly beneficial.”
VSL#3 JUNIOR is natural and comes in a child-friendly watermelon flavor. It can be mixed into cold drinks, such as water and juice, or foods. Natural, VSL#3 JUNIOR is also gluten free, Kosher and Halal certified. Each box contains 30 of the watermelon flavoured packets. VSL#3 JUNIOR is available nationwide, behind the counter, at participating pharmacies. As with all medical foods, the product must be used under medical supervision.
In addition to VSL#3 JUNIOR, Sigma-Tau distributes three other formulations for adults: VSL#3 DS prescription-only medical food packets, containing 900 billion bacteria; VSL#3 packets, containing 450 billion bacteria, and; VSL#3 capsules, containing 112.5 billion bacteria.
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered enterally (within or by way of the intestine) under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
All types of VSL#3 colonize the gastrointestinal (GI) tract with optimal quantities and types of probiotic (“good”) bacteria. Using this high concentration of several different strains of specially selected bacteria, VSL#3 products provide an optimal composition of good bacteria, enhancing the health of the GI tract and aiding in dietary management of IBS. Each packet of VSL#3 JUNIOR contains 225 billion colony-forming units (CFU). VSL#3 is a registered trademark of VSL Pharmaceuticals Inc. VSL#3 has been licensed from VSL Pharmaceuticals Inc. to Sigma-Tau Pharmaceuticals, Inc. for the US territory.
Sigma-Tau Pharmaceuticals, Inc. is dedicated to the global development and commercialization of medicines for patients with rare diseases.