Unique cannabinoid formulations, dosages and delivery systems for FDA approved synthetic THC
The Company’s Joint Pharma program is currently preparing for Phase II clinical trials starting in Q4 2016 using a unique pharmaceutical formulation and combination. Joint Pharma utilizes the “Entourage Effect,” combining Dronabinol (synthetic THC), an FDA approved compound, with PEA, PEA is naturally occurring in various food sources such as egg yolk, soybeans and milk. In parts of Europe, PEA derived products (e.g., Normast® and Pelvilen®) have been marketed as a food for special medical purposes. In April 2015, Health Canada added PEA to its list of Natural Health Products, a class of health products which includes vitamins, mineral supplements, herbal preparations, traditional and homeopathic medicines, probiotics and enzymes. in treatment of the high reward CNS indication of Tourette Syndrome (TS).
The BrainBright Pharma program of Therapix is targeted to the high value and underserved CNS market of mild cognitive impairment (MCI) using ultra low-dose THC. This program is scheduled to begin a Phase I study in Q1 2017. Recent studies have found that an ultra-low dose of THC protects the brain from long-term cognitive impairment which may be caused by lack of oxygen supply, seizures or use of drugs.