ExeGi Pharma has launched Visbiome and Visbiome Extra Strength, new probiotic formulations comparable to VSL#3 that relieve symptoms associated with ulcerative colitis, chronic pouchitis, irritable bowel syndrome and other GI conditions, according to a press release.
Visbiome and Visbiome Extra Strength are medical foods to be used under physician supervision, the latter of which requires a prescription, according to the press release. The products consist of a probiotic blend of eight strains of live, freeze-dried lactic acid bacteria, which have been tested in more than 60 peer-reviewed studies including double-blind, placebo-controlled trials, and is currently being investigated in over 20 trials worldwide, including an NIH-funded trial in individuals with HIV.
“More than 20 years ago, I created my probiotic formulation with the aim of helping patients manage complex conditions and support a healthy microbiome,” Claudio De Simone, MD, PhD, chief medical officer of ExeGi Pharma, said in the press release. “The benefits of this formulation have been demonstrated in rigorous research again and again, and I am pleased to partner with ExeGi Pharma to ensure continued access to the probiotic blend that patients and their health care professionals trust.”
De Simone previously partnered with VSL Pharmaceuticals to create VSL#3, but that license agreement expired at the end of January 2016. De Simone is now working exclusively with ExeGi Pharma, according to the press release.
“Patients who are managing conditions like ulcerative colitis, pouchitis and IBS often face a roller-coaster ride of ups and downs,” Martin Floch, MD, clinical professor of medicine at Yale and editor-in-chief of the Journal of Clinical Gastroenterology, said in the press release. “In my clinical practice, I’ve seen first-hand how the De Simone Formulation has helped my patients achieve stability in their conditions. It’s so important that they can continue to access the formulation that we both trust and that’s yielded tangible results.”
With the launch of Visbiome, ExeGi has also developed a reimbursement support hotline to assist patients with obtaining insurance coverage for Visbiome Extra Strength. The product will be packaged in “Active-Vials” to reduce moisture intrusion and protect potency, according to the press release.
“As an academic research gastroenterologist, it gives me a great deal of confidence knowing that patients will have access to such an extensively and rigorously tested product,” Claudio Fiocchi, MD, an IBD expert and professor of molecular medicine, Lerner College of Medicine and department of gastroenterology & hepatology at the Cleveland Clinic Foundation, said in the press release. “Professor De Simone’s commitment to maintaining the integrity of his blend means that the known therapeutic effects of his original probiotic formulation will continue to be available to patients with a vast range of gastrointestinal ailments.”
Disclosures: De Simone is an employee of ExeGi Pharma. Healio Gastroenterology was unable to confirm Fiocchi and Floch’s relevant financial disclosures at the time of publication.