THX-TS01: THC and PEA Formulation for the Treatment of Tourette Syndrome
Tourette Syndrome (TS) is a neuropsychiatric disorder with increased prevalence among children. According to the 2011–2012 National Survey on Children’s Health, one out of every 360 children in the US has been diagnosed with TS, and about 35,000 children have moderate or severe TS. Symptoms include physical and vocal tics that can be disabling and associated with hyperactivity, anger control problems, sleep disorders, and obsessive compulsive behavior. Current pharmacological treatments have provided very limited efficacy and are almost always accompanied by severe side effects. Medications used to treat TS, such as antipsychotic drugs, Alpha Adrenergic Agonists used for hypertension and migraine headaches, and anticonvulsant drugs, often have ‘black box warnings’ (the strictest warning included in the labeling of prescription drugs or drug products by the FDA) for serious hazards.
Several studies show the beneficial effects of THC in treatment of TS patients. The THX-TS01 program takes a unique approach to cannabinoid formulation using the “Entourage Effect,” in which Endocannabinoid system constituents work synergistically together. The Entourage technology is licensed by Therapix.
The Therapix THX-TS01 compound is a combination drug based on:
- Dronabinol (synthetic THC), the psychoactive molecule in the cannabis plant. Cannabinoids such as synthetic THC are used in the treatment of a wide range of medical conditions, such as pain reduction, anti-inflammation, and reduction or prevention of nausea. They are used by cancer patients undergoing chemotherapy and for mental health conditions such as anxiety and posttraumatic stress disorder.
- 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.
The “Entourage Effect” was first described by Professor Raphael Mechoulam in 1998. Professor Mechoulam, a world renowned expert on pharmaceutical cannabinoids and member of the Therapix Medical Advisory Board. Based on Therapix research and preclinical studies, dronabinol and PEA have been shown to work better together than use of THC or PEA alone. PEA is in the endocannabioid family and is believed to be a pain reliever and anti-inflammatory agent. Combining PEA with dronabinol may stimulate cannabinoid receptors, inhibit metabolic degradation, and thus increase uptake of THC. The overall benefits of the PEA combination are considered to be an increase in efficiency of oral administration, enabling a decrease in dosage and lowering of side effects and adverse events.
Therapix is seeking orphan drug designation for its compound.