Upon approval, VITA-100 would be designated as an orphan drug for the treatment of pediatric ulcerative colitis (UC), a form of pediatric inflammatory bowel disease. The U.S. Orphan Drug Act (ODA) of January 1983 is meant to encourage development of drugs for rare diseases, and review by the FDA’s Office of Orphan Products Development can expedite the evaluation and eventual market approval of products that demonstrate significant promise for the treatment of these conditions.
Vitality Biopharma’s gut-targeted cannabosides enable delivery of THC without psychoactivity or intoxication, which may enable more widespread use of cannabinoids for treatment of pediatric digestive disorders. The Company has already completed studies that demonstrate the efficacy of cannabosides for treatment of preclinical models of colitis. Cannabosides were able to reduce weight loss, decrease damage to the colon, and markedly improve gastrointestinal health compared to the placebo controls.
“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” said Robert Brooke, CEO and Co-Founder of Vitality Biopharma. “Given the mounting clinical data documenting use of cannabinoids for treatment of gastrointestinal disorders, we are very excited about the potential of VITA-100 and our cannabosides platform to provide a meaningful impact for these patients, helping them to stabilize their disease and avoid debilitating surgeries.”
About Vitality Biopharma (VBIO)
Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn.
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