New Treatment for Pediatric Ulcerative Colitis Submitted for FDA Orphan Drug Classification

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A New, Non-Corrosive, Non-Irritating Treatment for Pediatric Ulcerative Colitis Has Been Submitted for FDA‘s Orphan Drug Classification

Financial Press Commentary

(FinancialPress) — The US Federal Drug Administration (FDA) has received an orphan drug designation request from Vitality Biopharma Inc. (OTCQB: VBIO)—a cannabinoid prodrug pharma corporation in the process of developing its flagship asset VITA-100, targeting the treatment of pediatric ulcerative colitis.

A positive response from the FDA’s Office of Orphan Products Development stands to benefit the company as it continues to develop the treatment.

The drug could potentially serve to alleviate the pediatric condition – which holds a rare disease classification itself.

VITA-100 holds the particular distinction of being based on Vitality’s proprietary “cannabosides” technology—a delivery system aimed to deliver therapeutic-grade cannabinoids (THC and CBD) directly to the targeted area in the gastro-intestinal tract without the composite entering the bloodstream. The benefit of this delivery method is the avoidance of all psychoactive effects traditionally associated with it.

“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 the company.

“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,” he added. 

The cannabosides technology has already been tested and demonstrated as effective by the company—particularly in preclinical models of colitis.

The non-intoxicant formulation also helped reduce the side effects that often come with similar treatments such as weight loss, damage to the colon and overall improved GI health when compared to placebos.

The restricted delivery-drug, enabled by the company’s know-how in enzymatic glycosylation, is geared up to be available as an oral pharmaceutical.

Formerly a stevia-focused company, Vitality is one of the few companies operating in the cannabinoid pharmaceutical sector.

It found its niche in obtaining its own intellectual properties in the aforementioned delivery system.

Their inaugural discovery in the field came as it attempted to make stevia taste better. They found a much better – and more exploitable – result in lieu.

Therapeutic synthetic THC, AKA dronabinol, has been an instrumental factor in giving companies such as Vitality a head start over the rest of the medicinal cannabis sector, as the FDA‘s 2016 approval has allowed them to delve deeper into the medical uses and benefits of the cannabinoid.

The legal THC sector has been making waves ever since the approval, with companies such as Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX) and INSYS Therapeutics, Inc. (NASDAQ: INSY) releasing their products Marinol and Syndros respectively – both of which use the cannabis derivate as the active ingredient. GW Pharmaceuticals plc (NASDAQ: GWPH) is also expected to have its Sativex (naxibimol) product approved soon.

Vitality‘s submission brings it one step closer to tapping into the massive medicinal cannabinoid market, putting it neck and neck with the giants of the sector while having only a fraction of, for example, GW‘s $3.723 billion market cap.

POTENTIAL COMPARABLES

Valeant Pharmaceuticals, Inc. (NYSE: VRX) (TSX: VRX)

Valeant operates as a pharmaceutical and medical device company worldwide. Among its many products, the company offers Uceris to get ulcerative colitis under control; and Zegerid to treat certain stomach and esophagus problems; Tobramycin and Dexamethasone ophthalmic suspension for steroid responsive inflammatory ocular conditions; and Latanoprost medicines to treat a type of glaucoma. The company was founded in 1983 and is headquartered in Laval, Canada.

INSYS Therapeutics, Inc. (NASDAQ: INSY)

Insys Therapeutics, Inc., is a specialty pharmaceutical company, which develops and commercializes supportive care products. The company markets SUBSYS, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant cancer patients in the United States. Its lead product candidate is SYNDROS, an orally administered liquid formulation of dronabinol for treating CINV and anorexia associated with weight loss in patients with AIDS. The company is also developing Cannabidiol Oral Solution, a synthetic cannabidiol for childhood catastrophic epilepsy syndromes; and other product candidates, including other dronabinol line extensions and sublingual spray product candidates. Insys Therapeutics, Inc. is headquartered in Chandler, Arizona.

GW Pharmaceuticals plc (NASDAQ: GWPH)

GW is a biopharmaceutical company, engaging in discovering, developing, and commercializing cannabinoid prescription medicines derived from the Cannabis plant. GW markets Sativex, for the treatment of spasticity due to multiple sclerosis, which is also in Phase II trials for neuropathic pain. Their product pipeline includes Epidiolex, which is in Phase III clinical development to treat dravet syndrome, lennox-gastaut syndrome, tuberous sclerosis complex, and infantile spasms. GW Pharmaceuticals plc was founded in 1998 and is based in the UK.

About Vitality Biopharma (OTCQB: 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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