THX-TS01

Research and Development

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.

Unique Approach

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.
Entourage Effect THC and PEA image

Entourage Effect”

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.