An orphan drug designation request for Vitality Biopharma’s prodrug VITA-100, a cannabinoid that treats pediatric ulcerative colitis, has been sent to the U.S. FDA.
An orphan drug designation request for Vitality Biopharma’s prodrug VITA-100, a cannabinoid that treats pediatric ulcerative colitis (UC), has been sent to the U.S. Food and Drug Administration (FDA).
Vitality is a Northern California based corporation dedicated to developing cannabinoids as lifelong treatment options for serious neurological and inflammatory disorders.
“In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications,” stated Robert Brooke, CEO and Co-Founder of Vitality Biopharma in a press release. “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.”
Ulcerative colitis is a digestive disease that causes abdominal pain, diarrhea, intestinal obstruction, and growth delay in children. VITA-100 delivers THC to the gut through targeted prodrug technology, providing therapeutic benefits to the patient. This process causes no psychoactivity or intoxication from the prodrug within the patient due to the systematic delivery of THC which limits the amount that enters the bloodstream.
The company writes on its website that prodrugs are medications that are metabolized into a pharmacologically active drug. These oral doses of cannabinoids have a lower risk of triggering harmful side effects than specialty pharmaceutical drugs.
In preclinical studies conducted by the pharmaceutical company, patients who took cannabosides for the treatment of colitis had reduced weight loss, decreased damage to the colon, and improved gastrointestinal health compared to the placebo group. Vitality plans to complete a first-in-man clinical study during the first half of 2018 that would analyze the efficacy of VITA-100 in treating inflammatory bowel disease, irritable bowel syndrome, and narcotic bowel syndrome.
In independent clinical trials, THC improved visceral pain and abdominal cramping through cannabinoid treatment.
“As independent clinical studies are demonstrating the therapeutic effects of THC, we are well positioned with our VITA-100 gut-restricted prodrug formulation,” said Brooke in a press release. “Many parents, pediatric gastroenterologists, and affected adults are eagerly seeking a treatment option that provides therapeutic effects without the resulting psychoactivity. In developing a THC prodrug, we will also benefit from a robust track record of safety and history of FDA drug approvals.”
Vitality intends for this groundbreaking prodrug technology to enable more use of cannabinoids for the treatment of pediatric digestive disorders.