In 2018, Health Canada approved a Phase 1 study of vaporized cannabinoid-derived treatment for chronic pain. Canadian company Tetra Bio-Pharma announced the accelerated development of its second-generation drug inhalation program for fibromyalgia and uncontrolled pain. The Phase 1 study in healthy volunteers using vaporized PPP001, its codename, was successfully completed. PPP001 is also in Phase 3 testing as a cancer pain drug.
Fibromyalgia is a debilitating condition with constant, chronic pain and a heightened sensitivity. Treatment of conditions associated with fibromyalgia includes medications and prescribed opioids. The development of PPP001 would give options for pain management without the use of opioids.
The new pain remedy is being reported to have the most promising effects when smoked or vaped instead of eaten in the form of an edible. PPP001 relies on a proprietary blend of strains that is estimated to be 9.5 percent THC and 2.5 percent CBD. In July 2018, Tetra Bio-Pharma entered into a co-development agreement with Storz & Bickel for vaporizer design and manufacturing. The study investigated the time to absorb and relieve the pain as well as the safety of using vaporized medicine.
The study determined how much cannabinoid and terpene was distributed in the body by either smoking or vaporizing. It was reported that a smoked cannabis product is delivered more quickly to the brain than other means such as edibles.
There are important differences in some cannabinoids and terpenes when using either a pipe or vaporizer. Tetra Bio-Pharma will use isolates or synthetic-based supplies of cannabinoids and terpenes to develop prescription cannabinoid-derived medicines.
Tetra Bio-Pharma began preparations in 2018 for a research site to be located in the United States to conduct its fibromyalgia clinical trial in both Canada and the US.
“We previously communicated that after reviewing the human clinical data, Tetra anticipated proceeding into phase 2 clinical trials in fibromyalgia patients,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma, in a press release. “We are committed to this target and plan to accelerate this development in the USA as well. Overall, 2018 was a productive year after completing several clinical trials, and we expect 2019 to build on this as we accelerate this program.”
Tetra Bio-Pharma has been created as a cannabinoid-based drug development and innovation with Health Canada-approved and FDA-reviewed clinical programs. The company has several subsidiaries developing pharmaceuticals, natural health, and veterinary products containing cannabis and other medicinal plant-based elements.
Cannabis in Canada was labeled a controlled substance under the Controlled Drugs and Substances Act — it was illegal to grow, possess, distribute, or sell cannabis until changes in Canadian law. On July 30, 2001, it became legal in Canada to possess cannabis for medical purposes as supported by a physician. Since July 2015, licensed producers could supply cannabis for medical purposes in fresh, dried, and oil forms (Health Canada, 2015). On August 24, 2016, under the Access to Cannabis for Medical Purposes Regulations, Canadians with a medical document could produce cannabis for their own medical purposes or designate someone to produce it for them.
This latest development of research and testing cannabinoid-derived treatment is in line with the direction of Public Safety Canada. In 2017, it hosted a symposium on cannabis including researchers, representatives from provincial and territorial governments, personnel representing universities, and non-governmental organizations to discuss cannabis-related research.
The symposium reported that there was a lack of data in many areas concerning cannabis. Research on lifelong cannabis use and tolerance was needed as well as research to understand the interaction between cannabis and prescribed medications.