Vitality Biopharma Seeks FDA’s Orphan Drug Status for Cannabinoid Therapy VITA-100

Vitality Biopharma Seeks FDA’s Orphan Drug Status for Cannabinoid Therapy VITA-100
Vitality Biopharma is seeking orphan drug designation from the U.S. Food and Drug Administration (FDA) for its targeted cannabinoid therapy, VITA-100, for the treatment of pediatric ulcerative colitis. The FDA grants orphan drug status to promising treatments for rare diseases affecting fewer than 200,000 people per year in the United States. Upon approval, the designation is expected to expedite and facilitate the clinical development and regulatory review of the treatment. The regulatory status also offers additional incentives, including tax credits for clinical testing, seven years of market exclusivity, fast-tracking for regulatory proceedings, and exemption from prescription drug user fees. "In young children, ulcerative colitis can often be hyperactive and difficult to control using existing FDA-approved medications," Robert Brooke, CEO and co-founder of Vitality Biopharma, said in a press release. VITA-100 was developed to deliver directly to the gut two of the active ingredients of cannabis plants — cannabidiol and tetrahydrocannabinol (THC) — to reduce localized inflammation and pain. Because the activity of the drug is targeted to the gut, it does not caus
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